JP7795126B2 - Oral care support system - Google Patents

Description

The present invention provides a specimen test that combines a blood test that can estimate the state of glucose metabolism in the body, which is increasingly known to be related to at least oral health, with a test that utilizes an antigen-antibody reaction to identify bacterial species and strains that may be affecting oral health. By implementing the test of the present invention in specimen tests that are commonly performed as part of medical procedures and for managing, maintaining, and improving overall health, it is possible to support the maintenance and improvement of the oral health of the general public. Furthermore, the present invention relates to an oral care support system that provides the test results to dental medical institutions and institutions that provide dental health guidance, enabling effective treatment and guidance on maintaining and managing oral health. It also provides information on the state of the subject's oral function and information useful for maintaining and improving oral function, thereby maintaining and improving the subject's oral health and ultimately maintaining and improving the subject's quality of life.

It is becoming increasingly clear that maintaining and improving oral function is essential to maintaining and improving people's quality of life. In particular, with the rapid aging of the population in recent years, which significantly reduces oral function, there is an increasing need to maintain and improve oral health for a wide range of age groups, including younger generations, in order to maintain and improve future oral function. Maintaining and improving oral health is a prerequisite for maintaining and improving oral function. The national government also states that "periodontal disease does not produce clear subjective symptoms in the early stages, and by the time symptoms such as loose teeth and purulent discharge from the gums appear, it is often difficult to prevent tooth loss, even with dental health guidance and dental treatment. Therefore, periodontal disease screening is essential to prevent tooth loss, and it is important to detect periodontal disease early so that appropriate dental health guidance and dental treatment can be received." Therefore, "maintaining oral health and chewing significantly impacts independence, including speaking, maintaining posture, chewing, and swallowing, and is also expected to be effective in preventing the need for nursing care." For this reason, the government is currently conducting periodontal disease screening for people aged 40, 50, 60, and 70, based on the idea that "improving and maintaining oral function and oral health can be expected to maintain and improve quality of life in old age." However, the current situation is that dental disease screening has not been widely implemented, with estimated national attendance rates of 1.27% in 2000, 2.74% in 2005, 3.34% in 2010, and 4.30% in 2015, indicating that it is hardly being implemented at all. Furthermore, even dental screening, which is simpler than periodontal disease screening, only accounts for approximately half (52.9%) of those aged 20-79. This is particularly true for men, with attendance rates of 43.3% for those aged 20-29, 44.6% for those aged 30-39, and 49.4% for those aged 40-49 (National Health and Nutrition Survey (2016)). In order to resolve the above issues, the government announced in May 2022 that it would begin considering whether to include in its "Basic Policy" for economic and fiscal management "a policy to introduce a system of universal dental checkups, which would make annual dental checkups mandatory for all citizens," and measures to make this a reality will be taken in the future.

Periodontal and dental examinations require at least 20-40 minutes for each subject, as they involve specialized dentists and dental hygienists assessing the condition of each subject's teeth, gums, and plaque through visual observation and testing with instruments and reagents. To successfully conduct these examinations, it is necessary to secure a sufficient number of specialists to accommodate the number of subjects, as well as provide specialized equipment and tools, such as examination chairs equipped with a device capable of shining visible light into the oral cavity, an environment allowing for mouth rinsing, and specialized testing instruments. Accommodating a large number of subjects requires a large testing venue appropriate for the number of subjects, which is one of the factors hindering the widespread implementation of these examinations. Furthermore, dental examinations typically cost around 5,000 yen per subject, even when only basic tests are performed. Implementing dental examinations for the entire population would require a huge amount of funding. Furthermore, since examinations are preferably conducted approximately once a year, funding poses a major challenge. With regard to the burden of implementation costs, the national budget and health insurance budget are already in a tight spot, so it will be difficult to raise all the funds. If the costs were to be borne by the subjects, it is unlikely that subjects would be willing to bear the large costs to undergo regular checkups, considering that the test is not directly related to life and that personal income for those below the middle class is declining significantly. Therefore, even if a universal dental checkup system were enacted, it can be predicted that major challenges would be resolving and realizing the shortage of experts, the testing environment such as testing locations and equipment, and the large amount of funds required to implement the program.

Meanwhile, in order to provide information on bacteria believed to cause periodontal disease, tests have been proposed that use markers to identify specific bacteria contained in samples collected from the oral cavity (Patent Documents 1 and 2). This test can accurately determine the presence or absence in the oral cavity of specific bacteria believed to be the cause of oral infections in a broad sense, such as periodontal disease. However, because periodontal disease is diagnosed by checking the condition of the periodontal tissues and the degree of inflammation based on diagnostic criteria, this test is only performed by a select few dentists who need reference information when treating periodontal disease.

WO 2004/106541 WO 2000/039583

In recent years, it has become increasingly known that poor oral hygiene can have adverse effects on systems other than the oral cavity, such as systemic diseases, and can reduce quality of life, especially in the elderly. Maintaining and preventing the decline of oral function associated with aging, as well as improving and maintaining the state of the oral cavity, which is closely related to oral function, to a healthy state are becoming major challenges in today's aging society. Meanwhile, due to factors such as the testing environment and the costs involved, tests to assess oral health, such as periodontal disease checkups and dental checkups, are not widely conducted among the general public. It is therefore necessary to regularly assess oral hygiene status using methods that eliminate these obstacles to implementation, and to improve, maintain, and manage oral health.

Therefore, in light of the above-mentioned circumstances and as a result of extensive research, the present invention seeks to provide a specimen test that can assess oral health status, without imposing a significant burden of effort or expense on subjects or test administrators, in order to improve and contribute to the maintenance of oral health in the general public. Specifically, one or more test items selected from the group consisting of nucleic acid tests, antigen tests, and antibody tests for oral bacteria and Candida that may affect oral health status, as well as blood tests such as blood glucose and hemoglobin A1c levels, are conducted. The results of these specimen tests are used to predict the subject's oral health status and to identify subjects who require dental treatment, periodontal disease screening, dental checkups, or dental health guidance. By communicating these test results and predictions to subjects or those requesting the tests, it is possible to treat oral disease at an early stage, implement effective preventive measures to prevent oral disease and oral problems, and regularly provide optimal dental treatment and dental health guidance. The present invention provides a specimen test and oral care support system that makes these possible.

The present invention can be performed in conjunction with blood tests during health checkups and medical procedures, which have traditionally been widely conducted among the general public. This does not require significant burdens on subjects or test administrators in terms of environmental preparation, labor, or cost, making it highly feasible for widespread implementation. Therefore, implementing the present invention can contribute to the early improvement and maintenance of the oral health of the general public. Furthermore, because it is possible to predict subjects who require dental examinations, checkups, and dental health guidance, specialized medical treatment need only be provided to a subset of at-risk subjects, rather than the entire population. This is simpler and significantly less costly than conducting periodontal disease and dental checkups on all subjects, while achieving the same or greater effectiveness. Therefore, implementing the present invention makes it possible to conduct regular examinations that are as effective as national dental checkups, enabling accurate and efficient oral hygiene education and medical treatment for subjects who require dental treatment, dental health guidance, and other educational activities to improve dental hygiene. Furthermore, in the prevention and treatment of oral diseases, various information about each subject that may affect oral health status and oral treatment can be communicated to dentists and other medical professionals, making it possible to refer to it when considering effective treatments and prognosis care methods, and to provide optimal dental health guidance for each subject. Furthermore, because it makes it easy to understand a patient's oral health status even in medical institutions that do not have an oral care department, it is expected that appropriate measures will be able to be taken in medical fields other than oral care in terms of improving the effectiveness of treatment and postoperative prognosis.

1 is an explanatory diagram showing the configuration of a support system according to a representative embodiment of the present invention. FIG. 2 is a block diagram showing the configuration of a support server in the support system. FIG. 10 is a block diagram showing another configuration of the support server in the support system.

That is, the present invention includes the following inventions.
Item 1: Specimen tests that include one or more tests selected from the group consisting of nucleic acid tests, antigen tests, and antibody tests related to oral bacteria and/or Candida, and one or more tests selected from the group consisting of blood glucose level measurement, hemoglobin A1c level measurement, oxidized HDL level measurement, and high-sensitivity CRP test.
Item 2: The specimen test according to Item 1, wherein the oral bacteria include at least Porphyromonas gingivalis .
Item 3: The specimen test according to Item 2, wherein the oral bacteria include at least two or more different strains of Porphyromonas gingivalis .
Item 4: A specimen test according to any one of Items 1 to 3, which provides information about the subject's oral cavity in addition to the results of the test items.
Item 5: The specimen test according to Item 4, wherein the information about the subject's oral cavity includes information contained in any of information about oral health status, information about risk factors in oral health, information about oral hygiene, and information about recommended oral care products.
Item 6: The specimen test according to any one of Items 4 or 5, wherein the information relating to the subject's oral cavity includes information relating to dental health guidance.
Item 7: The specimen test according to any one of Items 1 to 6, wherein the test related to oral bacteria and/or Candida includes two tests: an antibody test and either a nucleic acid test or an antigen test.
Item 8: An oral care support system that uses the results information of one or more tests selected from the group consisting of nucleic acid tests, antigen tests, and antibody tests related to oral bacteria and/or Candida, and either of the information (i) and (ii) below, to create information useful for improving or maintaining the subject's oral cavity in a healthy state, and provides the results information and the created useful information to the subject.
(i) Information on the results of specimen tests, including blood tests that include at least one or more of the following test items: blood glucose level measurement, hemoglobin A1c level measurement, oxidized HDL level measurement, and high-sensitivity CRP test. (ii) An oral care support system that creates useful information for improving or maintaining the oral health of a subject by utilizing one or more pieces of information from one or more of the following information items: subject information item 9: specimen test results information from one or more tests selected from the group consisting of nucleic acid tests, antigen tests, and antibody tests related to oral bacteria and/or Candida, including at least one or more pieces of general attribute information such as the subject's own gender, age, height, weight, waist circumference, BMI, waist-to-hip length ratio, and medical history information of blood relatives; subjective information on oral and general health status; treatment history information; oral hygiene habits; actual information on dietary, lifestyle, exercise, drinking, and smoking habits; bedtime behavior information; and psychological state information; and information from one or more of the following information items (i) and (ii) below, and provides at least the created useful information and specimen test results information to the person requesting the test and/or the subject.
(i) Information on the results of specimen tests, including blood tests that include at least one or more test items selected from the group consisting of blood glucose level measurement, hemoglobin A1c level measurement, oxidized HDL level measurement, and high-sensitivity CRP test; (ii) Subject information Item 10: The oral care support system according to any one of Items 8 or 9, wherein the oral bacteria include at least Porphyromonas gingivalis, including one or more of the following information: general attribute information such as the subject's own gender, age, height, weight, abdominal circumference, BMI, waist-to-hip length ratio, medical history information of blood relatives, self-awareness of oral and general health status, treatment history information, oral hygiene habits, actual information on dietary, lifestyle, exercise, drinking, and smoking habits , bedtime behavior information, and psychological state information.
Item 11: An oral care support system according to Item 10, wherein the oral bacteria include at least two or more different strains of Porphyromonas gingivalis .
Item 12: The oral care support system according to any one of Items 8 to 11, further comprising one or more evaluations from the group consisting of: understanding and evaluation of oral function and oral condition using images and videos of the oral cavity; evaluation of oral function using videos including the head during chewing and/or vocalization and chewing sounds; and oral diadochokinesis.
Item 13: An oral care support system according to any one of Items 8 to 12, wherein some or all of the test results of the specimen test and information necessary for maintaining and improving the subject's oral cavity in a healthy state, created from the test results of the specimen test, are stored in an electronic medical record or a database used for the subject's health management, and are used to support medical procedures in the fields of dentistry and oral surgery and to support oral health management of the subject.
Item 14: The oral care support system according to any one of Items 8 to 13, wherein the information useful for improving or maintaining the oral cavity of the subject in a healthy state includes determining whether the subject needs dental health guidance and communicating the determination result to the subject.

The oral bacteria tested in the present invention refer to bacteria present in the oral cavity and throat, which are said to number more than 400 to 800 species. The types of bacteria that constitute the normal oral flora vary from subject to subject, and even within a given subject, they are known to fluctuate depending on age, oral hygiene status, systemic diseases, metabolism, and other factors. While the presence or absence of periodontal disease, caries, and other conditions is typically assessed during dental examinations and dental treatments, the technology of the present invention not only provides a simple method for predicting these conditions, but also provides information that can be used to estimate oral infection risks, such as the risk of oral infection contraction and recurrence, the likelihood of oral infection becoming severe, and the presence and severity of constitutions that make standard oral infection treatments and preventative measures less effective. Therefore, oral bacteria tested in the present invention are preferably bacteria known to affect oral health, and even more preferably bacteria that may affect disease onset and progression. In addition to bacteria, the fungus Candida albicans is also a known causative agent of oral infections, making it a preferred target for testing. Examples of bacteria that can have a negative impact on oral health include the three bacteria known as the red complex, Porphyromonas gingivalis , Treponema denticola , and Tannerella forsythia , which are associated with periodontal disease; Aggregatibacter actinomycetemcomitans (formerly known as Actinobacillus actinomycetemcomitans ); and the orange complex, Prevotella intermedia , Eubacterium nodatum , Fusobacterium nucleatum , Fusobacterium polymorphum, and Prevotella nigrescens . Prevotella nigrescens, Peptostreptococcus micros , Campylobacter rectus , Campylobacter showae , Campylobacter gracilis , Streptococcus constellatus , etc. Other bacteria known to have a direct or indirect relationship with dental caries include Streptococcus mutans , Streptococcus sobrinus , Actinomyces naeslundii , Actinomyces viscosus , Actinomyces odontolyticus , and Actinomyces oris , as well as Corynebacterium matruchotii , known to be associated with plaque formation, Actinomyces israelli , known to be associated with jaw actinomycosis, and Streptococcus agalactiae , known to be associated with invasive infections in the elderly.

"Related to oral bacteria or Candida fungi" means that the subject of the specimen test is nucleic acid, antigen, or antibody derived from oral bacteria or Candida fungi, or nucleic acid, antigen, or antibody that exhibits reactivity equivalent to the genes, antigens, and antibodies derived from the above. Specifically, in the case of nucleic acid testing, the subject of the specimen test is nucleic acid corresponding to each of the oral bacteria or Candida fungi that are the subject of the specimen test; in the case of antigen testing, the subject of the specimen test is antigen corresponding to each of the oral bacteria or Candida fungi that are the subject of the specimen test; and in the case of antibody testing, the subject of the specimen test is antibody corresponding to each of the oral bacteria or Candida fungi that are the subject of the specimen test, or a substance that exhibits reactivity equivalent to these.

There are no particular limitations on the testing methods that can be used for nucleic acid testing, as long as they utilize nucleic acids, and the optimal method can be adopted depending on the purpose of the test. Examples include testing methods that utilize conventional PCR, real-time PCR, reverse transcription PCR, nested PCR, hot start PCR, multiplex PCR, quantitative PCR, quantitative real-time PCR, touchdown PCR, inverse PCR, GC-rich PCR, two-step PCR, loop-mediated isothermal amplification, digital PCR, multiple displacement amplification such as whole genome amplification, strand displacement amplification, nicking enzyme amplification reaction, helicase-dependent amplification, recombinase polymerase amplification, strand-invasion based amplification, nucleic acid sequences based amplification, and transcription mediated amplification.

The antigens tested in antigen tests refer to the bacterial body itself, parts of the bacterial body, and compounds derived from bacteria that have an antigenic structure. When testing for antigens related to two or more bacteria simultaneously, a combination of antigen tests is performed using separate antibodies corresponding to each bacteria. In this case, it is desirable that the antibodies used for each antigen test do not substantially cross-react with at least other bacteria contained in the sample. In this context, "does not substantially cross-react" means that, as long as it is possible to distinguish the presence of antigens from each of the bacteria being tested, even if some cross-reaction occurs, it is considered to be no cross-reaction.

The antibodies tested in antibody tests refer to proteins that have the activity to specifically bind to antigens produced by antigenic stimulation with the bacteria themselves, parts of the bacteria, and compounds derived from the bacteria. Test antigens that react with antibodies include the bacteria themselves, parts of the bacteria, and compounds derived from the bacteria, as well as antigen peptides and combinations thereof that have similar reactivity. When testing for antibodies associated with two or more bacteria, an antigen-antibody reaction is used, utilizing antigens with distinct antigenic structures corresponding to each antibody. In this case, it is desirable to have no substantial cross-reaction between the individual antigen-antibody reactions or with antibodies against other bacteria contained in the sample. Here, "no substantial cross-reaction" means that, as long as it is possible to distinguish the presence of antibodies to each of the bacteria being tested, even if some cross-reaction occurs, it is considered to be no cross-reaction. Furthermore, while antibody tests can be qualitative tests that determine the presence or absence of antibodies, tests that can measure antibody titers are preferable, as this provides information that can be used to infer the degree and timing of infection.

One or more tests selected from the group consisting of nucleic acid testing, antigen testing, and antibody testing can be selected appropriately depending on the purpose of the test. Preferably, at least one of nucleic acid testing or antigen testing is performed in addition to antibody testing. Both nucleic acid testing and antigen testing can determine the presence of oral bacteria, Candida, or their fragments in the test sample at the time of testing. Because the former detects the presence of nucleic acids, while the latter detects the presence of antigens, the results of the two tests cannot be said to be completely consistent. Therefore, analysis of test results must take into account the principles of the test being performed and the specific test conditions. Nucleic acid testing and antigen testing also differ in terms of detection accuracy and test time. Nucleic acid testing using EMA (ethidium bromide monoazide) or PMA (propidium monoazide) can identify the possible presence of viable bacteria. Therefore, when conducting testing, the optimal method or methods should be selected based on a comprehensive consideration of the test purpose, testing costs, and testing environment. On the other hand, antibody tests can determine whether a subject has been infected with oral bacteria or Candida in the past, and whether the infection is still ongoing. Even if an antibody test identifies a suspected infection, the site of infection may be outside the oral region, so a simple judgment cannot be made based on the information from these tests alone. However, by combining and considering the information from these tests with other information, it is possible to understand the subject's condition, including their infection history.

The test samples used for nucleic acid, antigen, and antibody tests may be the same or different, but they must be collected at the same time. While sampling on the same day or even several days apart is considered "same time," sampling on the same day is preferable. Different sampling times are undesirable because they may alter the subject's condition and make it difficult to accurately ascertain the subject's information. It is most preferable to collect specimen test samples for all test items during health checkups or blood tests at medical institutions. Specimen test samples can be obtained by venous blood collection or collection from the oral cavity, throat, or oral tissue. Of these, specimen test samples used for antibody tests are preferably blood, blood components, or exudates collected from veins or oral tissue. Meanwhile, specimen test samples used for nucleic acid and antigen tests may be the same samples used for antibody tests, but preferably are collected from the oral cavity. Examples of specimens collected from the oral cavity include blood (including blood components), gingival crevicular fluid, dental plaque, tongue coating, and saliva. Although specimen test samples containing a mixture of these substances are acceptable, it is preferable to use samples that are as free of contamination as possible, as this may impair the accuracy of analysis of test results. If there is a possibility of contamination, it is most preferable to attach as much detailed information as possible to the collected specimen, such as the circumstances at the time of collection and the possibility of contamination, so that the test results can be analyzed easily. Furthermore, specimen test samples can be selected appropriately depending on the purpose of the test, but if information on periodontal tissues is to be obtained, samples containing at least one of gingival crevicular fluid, dental plaque, and saliva are preferred, with gingival crevicular fluid and/or dental plaque being preferred, and gingival crevicular fluid being most preferred.

Test results for nucleic acid tests and antigen tests include the species and number of bacteria detected, their proportion of the total (ratio to remittances), and the types detected in specific strains, and can be selected appropriately from these to provide the test result, taking into account the purpose of the test. Test results for antibody tests include the presence or absence of antibodies derived from specific species or strains and their antibody titers (neutralizing antibody titer, agglutinating antibody titer, etc.), and can be selected appropriately from these to provide the test result, taking into account the purpose of the test. Furthermore, by comprehensively examining the above test results (combination of bacterial species and their proportions, detected test items and test samples, etc.), inferences can be made regarding the health status of the oral cavity and included in the above test results. Examples of patent publications that describe related technologies include, but are not limited to, JP 2009-52945 A (method for testing or diagnosing periodontal disease using immunochromatography), JP 2022-96817 A, JP 2022-96815 A, JP 2022-96814 A, JP 2022-96812 A, and JP 2017-111095 A (all technical information related to measuring antibody titers against periodontal pathogens).

Regarding periodontal disease, the possibility of disease and susceptibility to disease risk can be assessed by comprehensively assessing the results of the presence or absence of detection of Porphyromonas gingivalis , a bacterial species known as the Red Complex, the number of bacteria, their presence ratio to the total number of bacteria, the test items detected, the type of test sample, etc. In addition, it is preferable to take into account information about the subject, such as the results of the subject's interview, information obtained from various information collection terminals and their analysis results, and information about the subject, such as past treatment history, as this will allow for more accurate risk assessment. Specifically, antibody titers, blood glucose levels, hemoglobin A1c levels, oxidized HDL levels (evaluation of caries risk, periodontal disease severity, and oral hygiene status: disclosed in JP 2022-171275, JP 2022-171263, JP 2022-171272, etc.), blood test items such as a preference CRP test, BMI (Body Mass Index) values, the presence or absence of live bacteria in oral tissues, information on the subject's oral condition and awareness and consciousness regarding oral care, whether or not dental implants have been performed, intestinal bacterial flora information, information related to the subject's lifestyle (information on actual oral care behavior, dietary patterns, and lifestyle patterns (preferably including information obtained using an information acquisition terminal and the results of analyzing that information), whether or not the subject has a smoking habit, etc.), etc. may be appropriately selected and taken into consideration when making a judgment. In these specific cases, antibody titers can suggest the presence of trace amounts of viable bacteria in oral tissues, blood test items such as blood glucose, hemoglobin A1c, and oxidized HDL can indicate the likelihood of an inflammatory response, and the presence of dental implant sites makes deep infection in periodontal tissues relatively easy, making patients more susceptible to severe periodontal disease. High-sensitivity CRP test results can also suggest the possibility of a strong inflammatory response in periodontal tissues. Therefore, it is best to combine these test items appropriately. To further improve test judgment, it is also advisable to consider test information on bacterial species other than Porphyromonas gingivalis . Specifically, it is preferable to appropriately select one or more species selected from the two bacteria Treponema denticola and Tannerella forsythia (excluding Porphyromonas gingivalis ) of the Red Complex, Prevotella intermedia , and Aggregatibacter actinomycetemcomitans , and it is even more preferable to select all of these bacterial species. Furthermore, by considering the above information in addition to test results that provide specific bacterial strain information, it is possible to provide useful information for selecting effective and efficient periodontal disease treatment methods. As another example, if a high number of Prevotella intermedia bacteria is detected in a gingival crevicular fluid test sample, it suggests the possibility of periodontal disease. In particular, if the subject is adolescent, the test strongly suggests the possibility of adolescent gingivitis, and if the subject is pregnant, the test strongly suggests the possibility of pregnancy gingivitis. Furthermore, if, in addition to Prevotella intermedia , fusobacteria such as Fusobacterium nucleatum or spirochetes such as Treponema denticola account for a large proportion of the total number of bacteria detected, the possibility of (acute) necrotizing ulcerative gingivitis is suggested. Unlike ordinary gingivitis, (acute) necrotizing ulcerative gingivitis is accompanied by serious symptoms such as soft tissue necrosis, rapid periodontal destruction, and interproximal bone loss. Therefore, it is preferable to detect it at an early stage using the test of the present invention and take appropriate measures.

Regarding dental caries, Streptococcus mutans is widely known as the causative bacterium, but the presence of other bacteria such as Streptococcus sobrinus , Streptococcus downei , Streptococcus rattus, Actinomyces naeslundii , Actinomyces viscosus , Actinomyces odontolyticus , and Actinomyces oris is also thought to be one of the factors that cause dental caries, and is therefore a factor in risk assessment. Furthermore, when dental plaque is used as a test sample, the relationship between the ratio (A) of the number of Streptococcus sanguinis (formerly known as Streptococcus sanguis ) bacteria to the total number of bacteria detected in the plaque and the ratio (B) of the number of Streptococcus mutans bacteria (for example, the B/A ratio) is said to be closely related to the occurrence of caries sites in the oral cavity (for example, a B/A ratio of around 1-2 can suggest the possibility of pre-caries, while a value higher than this suggests the possibility of caries occurrence). Therefore, although Streptococcus sanguinis is not a causative bacterium of caries, it can also be included in specimen testing when the purpose is to assess the risk of caries.

It is known that the types of bacteria adhering to dental plaque surfaces change during the plaque formation process. Therefore, when dental plaque is used as a test sample, the stage of plaque formation, deterioration of oral health, and the risk of oral disease can be estimated by examining the main bacterial species detected. Specifically, Streptococcus gordonii , Streptococcus oralis , Streptococcus mitis , Actinomyces naeslundii , Fusobacterium nucleatum , Prevotella nigrescens , Porphyromonas pasteri , Veillonella dispar , Veillonella parvula , Aggregatibacter actinomycetemcomitans , Prevotella intermedia , Porphyromonas The presence of Porphyromonas gingivalis , Treponema denticola , and other bacteria, as well as their relative abundance relative to the total, can be used to estimate the maturity of dental plaque, the risk of oral disease, and the presence or absence of unpleasant symptoms such as bad breath. Corynebacterium matruchotii deposits calcium phosphate within its cells, which is known to be deeply involved in the formation of tartar through the calcification of dental plaque. Because this provides useful information from the perspective of tartar adhesion and tartar prevention, it can be used as a specimen for testing when the purpose includes risk assessment for tartar and tartar-related periodontal disease and caries. In addition, plaque that adheres to the tooth surface above the edge of the gums (supragingival plaque) can provide information useful for assessing the risk of caries and periodontal disease, while plaque that adheres to the tooth surface below the edge of the gums in the area known as the periodontal pocket (supragingival plaque) can provide information useful mainly for assessing the risk of periodontal disease.

In addition, if Candida albicans is detected in oral samples from elderly people, people with dry mouth, people taking steroids or chemotherapy, or people who wear dentures, it can be inferred that they have oral candidiasis or are at risk of developing it. Furthermore, if nucleic acid, antigen, or antibody tests on periodontal tissue samples suggest a mixed infection with Streptococcus constellatus and Prevotella intermedius , it can be inferred that a closed abscess may have developed in the oral cavity. Therefore, specimens can be tested for the purpose of assessing the risk of closed abscess.

Information about the subject's oral cavity that can be provided in addition to the test results is not limited to information related to periodontal disease, caries, dental plaque, etc. Examples include information on the body's internal state related to tongue coating, which can cause bad breath, glossitis, and taste abnormalities, recommendations for dental treatment if a patient is suspected of having a disease requiring medical treatment, recommendations for dental health guidance if poor dental hygiene is suspected, and information useful for improving, maintaining, and managing oral health, such as providing various information on maintaining and improving oral health, recommending oral care products, and how to use them correctly.

The present invention can also provide dentists, dental hygienists, and other professionals with information useful for dental checkups, dental health guidance, and dental treatment. Currently, most people do not visit dental clinics until they experience serious conditions, such as oral pain or swelling, and few regularly visit dental clinics for preventative oral health, which is considered desirable from an oral care perspective. Tooth and alveolar bone loss, recession, and severe periodontal pocket formation are often difficult to reverse, and medical interventions aimed at maintaining the current state rather than worsening the condition are often implemented. In particular, periodontitis, an advanced stage of periodontal disease, often requires a long period of time for treatment to be effective due to chronic inflammation and alveolar bone resorption. Therefore, if a subject's oral condition is severely deteriorated when they first visit a dental clinic, tooth loss may not be prevented, leading to eating disorders, a decline in quality of life, malnutrition, and the progression of dementia. Therefore, in oral health management, it is important to implement preventive dental measures, and if a person's health condition deteriorates, it is important to seek medical advice or treatment from a dental specialist as early as possible. The present invention can resolve the aforementioned issues by conducting antibody tests using blood samples collected at medical institutions that commonly conduct health checkups and blood tests for the purpose of general health management, thereby selecting individuals who are likely to require a dental specialist's consultation and recommending a dental visit. Additionally, by providing information on bacterial species that may affect oral health status, as well as blood test results such as blood glucose levels, hemoglobin A1c levels, oxidized HDL levels, and high-sensitivity CRP tests that may affect oral inflammation and its treatment effects, it is possible to provide information useful for selecting appropriate and effective treatment methods at dental medical institutions. Furthermore, even if periodontal tissues are diagnosed as healthy by visual observation or other tests, detection of antibodies to bacteria associated with oral infections in blood or gingival crevicular fluid samples may indicate an infection in the oral tissues that does not cause inflammation (a subclinical infection). People in this state are infected but show no or only very mild symptoms. Therefore, any trigger, such as minor changes in physical condition or deterioration of oral hygiene, can cause the symptoms of oral infection to progress, and because they are already infected, symptoms often progress much more quickly than usual. Furthermore, in addition to the early stage, if the patient has a systemic condition that can affect the progression of the disease, such as abnormal blood glucose metabolism, there is a risk that not only will the symptoms progress further, but treatment of the disease will take longer or even become more difficult. Therefore, it is important to take medical measures as early as possible before the symptoms progress. By understanding the state of asymptomatic infection, the present invention can enable early disease treatment and regular preventive measures, contributing to the maintenance and improvement of oral health.

The present invention can also provide an oral care support system that can provide many subjects with the information necessary to maintain and improve oral health, improve subjects' oral care awareness and behavior, and help subjects receive dental care more efficiently.

The oral care support system of the present invention collects and stores the results of one or more specimen tests selected from the group consisting of nucleic acid tests, antigen tests, and antibody tests related to oral bacteria or Candida, the results of at least one blood test of blood glucose level, hemoglobin A1c level, oxidized HDL level, and favorable CRP test value, and general attribute information such as the subject's own gender, age, height, weight, abdominal circumference, BMI, waist-to-hip ratio, and medical history information of blood relatives, self-awareness of oral and general health status, treatment history information, oral hygiene habits, actual information on dietary habits, lifestyle habits, exercise habits, drinking habits, smoking habits, and bedtime behavior information. The system includes a support server 1 that records one or more pieces of subject information selected from the following: and psychological state information. It estimates the subject's oral health status and risk of impairment using specimen test results such as nucleic acid tests and either or both of blood test result information and subject information. It creates information useful for maintaining or improving the oral health of each individual subject based on the estimated information. It provides the test results, estimated information, and the created information useful for improving or maintaining the oral health of the subject to subjects and healthcare professionals via a network, either directly or via a testing provider or test requester. Note that information useful for maintaining or improving oral health also includes the offer and actual provision of oral care services and products that businesses can provide to subjects. This system not only enables very simple and inexpensive information processing for a large number of subjects, but also effectively selects subjects who may have poor oral health and require specialist examinations, screenings, and guidance, or subjects who are likely to have poor oral hygiene and require oral health guidance. By providing the necessary medical treatment for subjects based on the provided information, it could potentially become a testing system that replaces universal dental checkups. The examination system of the present invention is extremely superior in that it is significantly cheaper, simpler, and faster to implement than actually conducting dental examinations for the entire population.

As shown in FIG. 1, the oral care support system of this embodiment includes a support server 1, a terminal 2 for inputting test results, and a terminal 5 for outputting information to communicate test results and other information to the subject, all connected via a network N such as the Internet to transmit and receive various information. The support server 1 is also connected to and communicates with the network N to transmit and receive various information. A computing device 3, which, if necessary, estimates the subject's oral health status based on test results and other necessary information and selects or creates appropriate information for each subject regarding maintaining and improving their oral health status when the support server is unable to process the information, is also connected via the network N such as the Internet to an external server 4, which obtains various information other than test results necessary to estimate the subject's oral health status and various information not stored in the support server that is necessary for selecting and creating information to provide to subjects regarding maintaining and improving their oral health status. External servers include databases utilizing the My Number system, electronic health insurance cards, and electronic medical records managed by medical institutions or specialized institutions. Information on subjects, etc., can be obtained from the external server and utilized, or information obtained or created by the oral care support system of the present invention can be transferred to the external server and utilized within the system.

In the oral care support system according to the above embodiment, the support server may be composed of two or more computers. In this case, the constituent computers are connected to each other via a connection means not involving the Internet, such as a local network, or via a network N such as the Internet. The connection means may be used in combination or may be mixed within the system. When multiple support servers are present, each support server can be assigned to perform tasks such as recording and data processing (calculation), as well as data and system backup, in an optimal manner for operating the system. When multiple support servers are present, at least one support server 1 must have the function of selecting test results and information useful for improving or maintaining oral health and transmitting such information to a designated terminal. Since test results and subject attribute information are personal information, from the perspective of confidentiality, the less frequently such information is transmitted and received, the better. If the data input location is geographically distant from the support server, the information can be recorded on a separate support server 1 connected to the input terminal without using a network such as the Internet. This significantly reduces the number of times personal information is transmitted and received over the Internet, thereby mitigating the risk of information leakage. Additionally, if the useful information generation unit of the processing device in the support server 1 cannot process or cannot handle all the data due to reasons such as processing capacity, a computing device outside the system can be used.

As shown in Figure 2, the support server 1 is composed of one or more computers each equipped with a processing device 10 equipped with a communication control unit 12 and storage means 11. Specifically, a conventional, general-purpose computer device can be used, consisting of a processing device 10 at the center, storage means 11, a communication control unit 12, and input operation means (not shown) such as a pointing device, keyboard, and display.

The processing device 10 is primarily composed of a CPU such as a microprocessor, and has a memory unit consisting of RAM and ROM (not shown) in which programs defining the procedures for various processing operations and processing data are stored. The storage means 11 can be selected from memory inside or outside the support server 1, a hard disk drive (HDD), a solid state drive (SSD), a removable disk exchange system (RDX), a redundant array of independent disks (RAID), etc. Some or all of the contents of the storage unit may also be stored in the memory or hard disk of another computer communicatively connected to the support server 1.

The processing device 10 is broadly divided into two functional sections: an "information collection and recording function" that acquires information necessary for system operation and stores it in the storage means of a designated support server; and an "information generation and transmission function" that acquires information from the recording means necessary for generating test result information to be provided to each subject and information useful for improving or maintaining the subject's oral health, and then creates and transmits the information to the terminal 5, which outputs the useful information. Specifically, each piece of information to be recorded is input from the terminal 2 as the information to be input is obtained and recorded in the recording means. In this case, for example, if there are multiple support servers, it is possible to specify a recording means for recording information for each information item to be input, or to specify a recording means for recording information on a subject-by-subject basis. It is desirable to adopt the optimal method for the "information generation and transmission function" that utilizes the recorded information from the perspectives of convenience and prevention of information leaks. When providing information to a subject, the information is provided by generating the test results to be provided and, if necessary, information useful for improving or maintaining the subject's oral health, and then compiling and transmitting this information to the terminal 5. The terminal 5 not only displays and prints the information on a display or the like, but also transfers the information via the terminal 5 to the subject's computer, smartphone, recording medium, etc. In this case, the support system terminal 5 is a computer owned by the subject or a terminal for acquiring information, and information can be sent directly from the support server to terminal 5, i.e., the computer owned by the subject.

The generation of information useful for improving or maintaining a subject's oral health involves reference to past findings and one or more of the following: (i) the results of one or more specimen tests selected from the group consisting of nucleic acid tests, antigen tests, and antibody tests related to oral bacteria or Candida; (ii) the results of blood tests, including at least blood glucose or hemoglobin A1c levels, oxidized HDL levels, and high-sensitivity CRP tests; and/or (iii) general attribute information, such as the subject's gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history of close relatives; subjective awareness of oral and general health status; treatment history; oral hygiene habits; dietary, lifestyle, exercise, drinking, and smoking habits; sleep behavior; and psychological state information. The subject information listed above has been shown to be related to oral health and can be useful information for estimating a subject's oral health. Past knowledge that can be used as reference includes, for example, factors that may differ from those of normal healthy individuals in the onset and treatment of oral disease, as well as factors that theoretically cannot be ruled out as being related to oral health. Based on these, test results are examined by creating unique assessment schemes and criteria. For example, nucleic acid tests and antigen tests can indicate the presence of live bacteria or parts of bacteria, and these are considered in conjunction with the origin of the test sample. For test samples collected from the oral cavity, knowledge of the relationship between the bacteria detected in the test and oral health status can be used to determine the need for prevention or treatment, the possibility of disease onset, and estimate the subject's risk of disease. Furthermore, if the test sample is collected from oral tissue, the possibility of infection can be estimated, although there is a possibility of contamination with oral bacteria due to the sample collection method. On the other hand, antibody test results can be used to estimate the presence of current or past infection. Meanwhile, blood glucose levels, hemoglobin A1c levels, and oxidized HDL levels are blood indicators that can determine whether or not a subject has an abnormality in their glucose metabolism and the extent to which it exists. These levels are also known to affect the incidence of inflammatory oral diseases such as periodontal disease and the effectiveness of treatment. High-sensitivity CRP tests can also detect the occurrence of inflammation, even in localized areas such as oral tissue. Therefore, this information can also be useful in estimating the oral health of subjects.

When there is only one support server 1, the support server 1 includes at least a subject attribute information storage unit that stores subject attribute information acquired by the subject general attribute information acquisition unit, a test information storage unit that stores test result information acquired by the test result information acquisition unit, a subject information storage unit that stores subject information acquired by the subject information acquisition unit, and a useful information storage unit that stores information useful for improving or maintaining the subject's oral cavity in a healthy state, generated by the useful information generation unit. On the other hand, when there are multiple support servers 1, the subject attribute information storage unit, test information storage unit, subject information storage unit, and useful information storage unit must be present on at least one of the support servers 1; however, multiple support servers 1 may be equipped with all of the storage units, and the storage units can be freely designed to suit the actual operation.

Periodontal disease is a typical oral disease that not only causes inconveniences such as bad breath and loss of aesthetic appearance due to gingival recession, but also leads to significant tooth loss, impairment of oral functions such as masticatory function, and systemic diseases such as malnutrition and mental disorders associated with eating disorders, thereby contributing to a decline in quality of life. Therefore, it is preferable that the oral care support system of the present invention includes one or more test items selected from the group consisting of nucleic acid tests, antigen tests, and antibody tests related to oral bacteria or Candida, and at least one test item selected from the group consisting of nucleic acid tests, antigen tests, and antibody tests related to Porphyromonas gingivalis . Furthermore, it is possible that multiple strains of Porphyromonas gingivalis may threaten oral health or cause inconvenience. Some strains of Porphyromonas gingivalis can be highly pathogenic in periodontal disease, have characteristics such as drug resistance that make standard treatments ineffective, or can contribute to the development of systemic diseases, so strain information is also useful for generating more effective subject information. For this reason, it is most desirable to include test items that target as many strains as possible.

In this invention, "the healthy state of the subject's oral cavity" also includes the meaning of "the state of healthy oral function." Therefore, "information necessary to maintain and improve the subject's oral cavity in a healthy state" also encompasses "information necessary to maintain and improve the subject's oral function in a healthy state." Oral function involves eating (taking food into the mouth), chewing, bolus formation and transport, swallowing, articulation, taste, touch, and saliva secretion, and is a fundamental function necessary for people to live a healthy life in society. Understanding these conditions is extremely useful for the subject. Furthermore, since there is a known close relationship between oral hygiene and diseases such as periodontal disease and dental caries, understanding both the state of the oral cavity and the state of oral function is extremely important from the perspective of maintaining and improving the subject's quality of life.

Existing technologies can be utilized to acquire information about oral function and the condition of the oral cavity. Examples include dedicated terminals for information collection, and multipurpose terminals such as smartphones equipped with dedicated applications or information collection devices. These terminals can transmit acquired information to the terminal 2 used for information input or directly to the support server 1 via a connection method that does not involve the Internet, such as Bluetooth®, infrared communication, or a wired line, or via a network N such as the Internet, and can also acquire information such as instruction information from the network. When collecting information about oral function and the condition of the oral cavity, the information necessary to achieve the purpose of the analysis is acquired and stored in digital format, processed as necessary, and then transmitted to the support server 1 or other device using the aforementioned method. When acquiring information from the subject using the terminal, information about the subject's oral function, such as the content and control of the information acquisition operation, may be acquired based on or utilize information transmitted from the support server 1 to the terminal used to grasp the condition of oral function. As shown in Figure 3, the information transmitted from the terminal is ultimately acquired by the oral function information acquisition unit of the processing device 10 and stored in the oral function information storage unit of the recording means. The information recorded may be the information obtained by the support server 1 from a terminal used to grasp the state of oral function, as is, or secondary information obtained by processing the information obtained from the terminal may be recorded in the oral function information storage unit. Furthermore, the information necessary for maintaining and improving the subject's oral cavity in a healthy state can be created by the useful information generation unit of the processing device 10 using the information recorded in the oral function information storage unit and the information necessary for information processing, such as information about the subject's oral cavity, subject information, and subject attribute information, and this information can be recorded in the useful information storage unit of the recording device 11.

The oral care support system of the present invention can also provide useful information to employees in the employee health management department of corporations and other organizations whose job it is to maintain and promote employee health, as well as to dental healthcare professionals. Currently, dental health guidance is often provided to individuals who dentists or other medical professionals determine are in need of dental hygiene guidance during dental examinations. However, in such cases, oral health has already been compromised, posing a challenge in that the timing is too late from the perspective of preventive dentistry, the primary goal of dental hygiene. Because the present invention facilitates large-scale and regular implementation, by utilizing the oral care support system of the present invention periodically and continuously, such as once a year, it is possible to identify subjects with poor oral health before oral diseases or other conditions become noticeable. By conducting dental checkups or encouraging selected individuals to visit a medical institution, dental treatment and dental health guidance can be provided at an early stage, before their oral health is significantly impaired. Furthermore, in dental medical procedures, detailed information on bacterial infections in the oral cavity can be provided, as well as information on the subject's overall condition and behavioral habits that may affect oral health. This allows dentists and other medical professionals to understand the above-mentioned reference information before taking necessary measures, enabling them to formulate effective treatment plans and preventive measures for recurrence.

As described above, subject information in this invention refers to at least the subject's general attribute information, such as the subject's gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, and medical history information of blood relatives; subjective information regarding oral and general health status; treatment history information; oral hygiene habits; actual information regarding dietary, lifestyle, exercise, drinking, and smoking habits; bedtime behavior information; and psychological state information. This information can be obtained from the subject's self-report, monitoring using a terminal device, or electronic medical records. Self-reporting methods include, for example, subject information from specific health checkups. In specific health checkups, subject information regarding medical history and subjective symptoms is obtained. Since specific health checkups also include blood tests for fasting blood glucose and hemoglobin A1c levels, nucleic acid testing and other tests can be performed using these blood samples, thereby enabling the present invention to be implemented without requiring any additional special measures. Some of the medical history information and subjective symptoms in specific health checkups are obtained in the form of questions posed to the subject, such as on a medical questionnaire. For example, in addition to medical history, there are generally items such as smoking habits, exercise habits, eating habits, drinking habits, and sleeping habits, and this information can be utilized.

Methods for understanding and assessing oral function and the state of the oral cavity are not particularly limited, but examples include the following. Important elements of oral function include chewing and swallowing functions. Understanding and assessing masticatory function include understanding and estimating jaw and tongue movements from facial video information while the subject is actually chewing; analyzing and understanding the amount of food placed in the mouth, the number of chews from ingestion to swallowing, and chewing speed (number of chews per unit); and understanding and assessing oral function during eating behavior from video of the movements of the upper body and jaw when putting food into the mouth. Understanding and assessing swallowing function include analyzing video information around the throat during swallowing, understanding the details of the swallowing movement state and evaluating swallowing ability from the displacement of various parts of the throat, and understanding and estimating swallowing function by analyzing sound information generated during swallowing. Examples of patent publications that describe related technologies include, but are not limited to, JP 2021-105878, JP 2022-126288, JP 2022-74671, JP 2022-68486, JP 2022-68485, and JP 2022-68483. Another example of a method for understanding and evaluating oral function is oral diadochokinesis. Oral diadochokinesis is a test method that evaluates the speed and dexterity of movements of the tongue, lips, soft palate, etc. based on the pronunciation situation. For example, by acquiring and analyzing audio information generated when performing the action of repeatedly pronouncing specific sounds such as "pa," "ta," and "ka" within a certain period of time, a method can be used to evaluate the speed and dexterity (skill) of movements of the tongue, lips, soft palate, etc., and understand oral function. On the other hand, examples of methods for acquiring information to understand and evaluate the condition of the oral cavity include the following. Examples of oral conditions include the location and condition of plaque, the presence and degree of tongue coating, the presence and degree of tartar, the state of tooth alignment, the condition of the gums (surface color; the presence and location and degree of gingival recession; the presence and location and degree of gingival swelling; etc.), the status of dental treatment (treatment area and treatment content, location of missing teeth and dentures, etc.), and understanding or estimation of occlusion. One method for acquiring this information is to capture and analyze images or videos of the mouth opening. For example, a smartphone's camera function can be used to acquire images or videos using a light source or other imaging aid, such as a mouth opener, that irradiates the measurement area with light of a specific wavelength, sunlight-like light, or ultraviolet light, depending on the purpose. Furthermore, by acquiring this information multiple times, if a single acquisition is partially missing or does not provide sufficient information for analysis, the missing information can be supplemented by comparing it with other information, and then analyzed. Examples of patent publications that describe related technologies include, but are not limited to, JP 2020-179173, JP 2022-171272, JP 2021-105878, JP 2022-97176, JP 2022-68486, JP 2022-68485, JP 2022-68484, and JP 2022-68483. Terminals for acquiring this image, video, and audio information may be dedicated devices, or office equipment such as smartphones with data collection software installed. However, they are not limited to devices that are capable of acquiring the information and have the functionality to transmit the acquired information to a support server, etc.

Oral functions other than mastication and swallowing can be assessed using the following methods. Examples include oral movement information (teeth grinding, chewing, chewing force, and range of jaw movement during swallowing), occlusal function (bite force (bite pressure) and occlusion condition), masticatory function (masticatory ability, number of chews, and mandibular movement ability), swallowing function (throat movement and swallowing force), tongue function (tongue movement ability, tongue pressure, and blood flow), saliva condition (pH and buffering capacity (ability to maintain pH within a normal range), saliva secretion rate, dryness of the oral cavity and throat area, calcium ion concentration in saliva, serum antibody titer for oral bacteria, immunoglobulin amount, active oxygen amount, oral stickiness, type and concentration of major gases as halitosis, tooth condition (interdental embrasure area), tooth surface color, and number of remaining teeth, and gum condition (color and blood flow).

More specifically, the bite force (bite pressure) of occlusal function can be obtained by measuring myoelectric potential, biting with a piezoelectric sensor, or measuring the myoelectric potential of the jaw or temples. The occlusal state can be obtained by capturing images and analyzing them using AI. Like bite force (bite pressure), chewing ability can be obtained by measuring myoelectric potential, biting with a piezoelectric sensor, or measuring the myoelectric potential of the jaw or temples. The number of chews can be obtained by measuring jaw movement or the myoelectric potential generated during chewing using image analysis, myoelectric potential acceleration, distance sensors, etc. Mandibular movement ability can be obtained from the myoelectric potential when the jaw is moved. Swallowing function and throat movement during swallowing can be evaluated and estimated using the Repetitive Saliva Swallowing Test (RSST), Water Swallowing Test (MWST), Food Test (FT), swallowing sound measurement (cervical auscultation), videofluoroscopic swallowing (VF), endoscopy, electromyography, and photoelectric sensor phase measurement. Swallowing force can be obtained by measuring the electromyography (EMG) generated when the throat moves. Tongue pressure can be obtained by measuring the pressure when a probe equipped with a piezoelectric or pressure sensor is held between the tongue and jaw. Tongue blood flow can be measured by pressing a probe equipped with an SpO2 photoelectric sensor against the tongue. Examples of patent publications that describe related technologies include, but are not limited to, JP 2021-105878 A and JP 2017-515565 A.

In addition, the pH and buffering capacity of saliva can be measured by using a sensor device equipped with a probe equipped with a pH sensor and holding the probe in the oral cavity. The amount of saliva secreted and the dryness of the oral cavity and throat area can be measured by using a sensor device equipped with a probe equipped with a capacitance sensor (impedance measurement) and holding the probe in the oral cavity.

The types and concentrations of the main gases that cause bad breath can be obtained by using a sensor device equipped with a gas/breath sensor nozzle and having the user blow their breath into the nozzle. The size of the interdental embrasures (opening area), tooth surface color, number of remaining teeth, and gum color can be obtained by having the user hold a sensor device equipped with a sensor that spectrally analyzes the light absorption pattern of near-infrared light in their mouth and performing color discrimination and image analysis. The blood flow rate in the gums can be obtained by having the user place a sensor device equipped with an SpO2 sensor in their mouth.

In addition, the information that the subject information acquisition unit acquires from the user's sensor-equipped terminal (sensor device) that can be used to understand the actual state of care includes tooth brushing patterns, such as the date and time of toothbrushing acquired by a switch signal, brushing time acquired by a timer, brushing area acquired by a gyro sensor, brushing speed acquired by an acceleration sensor, and brushing pressure acquired by a strain gauge or pressure sensor.

Such sensor devices can include various oral devices with sensors, such as a terminal equipped with sensors that monitors the tissue function levels related to chewing, swallowing, saliva secretion, tongue movement, occlusion status, chewing or swallowing behavior during eating, or behavior during sleep, a toothbrush attachment terminal for the oral care support system described in JP 2017-60661 A, or the GrindCare (registered trademark) terminal, a sensor-equipped product for preventing bruxism (teeth grinding and clenching) (related patents manufactured by Sunstar Suisse SA; European Patent No. 1610862, U.S. Patent No. 8160689, U.S. Patent No. 9149226, etc.).

The sensor device can be configured, for example, with a processing device at its core, memory means, input/output unit, image input unit, display/notification unit, and wireless/wired communication unit, and can be a device that obtains biological information, behavioral information, and care behavior information from inside and outside the oral cavity and pharynx using the sensors in the input/output unit and the image input unit.

A device with the following configuration can also be used as a means of accurately understanding dental hygiene behaviors such as tooth brushing. The device is powered on when the switch is turned on, when the device is removed from the docking station, or when movement is detected by an acceleration or biometric sensor. Information obtained from the sensors in the input/output section, along with the status of the sensor device (remaining battery level, usage time, wearing status, etc.), is transferred from each device that acquires subject information to an information terminal such as a computer or smartphone owned by the subject via short-range wireless communication (ANT+, Bluetooth, ZigBee, IrDA, etc.) via the wireless/wired communication section. When used online, sensor information is transferred to the information terminal via short-range wireless communication, and subject information such as tooth brushing behavior, teeth grinding behavior, and heart rate status is sent to the information terminal.

The information acquired by the device can be sent to the support server 1 or the information input terminal 2 by directly equipping each device with the functionality to send and receive information, or by sending information via the subject's computer or smartphone. Biometric information, behavioral information, care behavior information, advice information, and product information from inside and outside the oral cavity and pharynx can be displayed, and information such as the subject's attributes, overall health status, and behavioral diary can be input using an input unit such as a keyboard or microphone. Customer information and product information can also be captured as image information from an image input unit using a built-in camera or barcode reader. Interactive information transmission with the sensor device instantly displays care behaviors and the current condition of the oral cavity and pharynx, and the support server 1 also displays the results of analysis and evaluation based on information from the device. The aim is also to appropriately introduce related products based on analysis data and actual usage, thereby increasing convenience for the subject.

In addition, information on the device's status (remaining battery level, usage time, wearing status, etc.) along with sensor information from the sensor device can be received using short-range wireless communication (ANT+, Bluetooth (registered trademark), ZigBee, IrDA, etc.). When used online, for example, sensor information is transferred from the sensor device via short-range wireless communication, and subject information such as tooth brushing behavior, teeth grinding behavior, and heart rate status is sent to an information terminal. Information that must be notified immediately about tooth brushing behavior, such as high brushing pressure or fast brushing speed, can be transferred from the information terminal to the sensor device using short-range wireless communication. Data on the analysis and evaluation content displayed after oral care behavior is transmitted to the support server 1 via an internet connection via a wireless LAN such as Wi-Fi or a wired LAN.

For example, subjective symptoms of oral conditions that can be obtained through user input include sensitive teeth, sticky mouth, dry mouth, difficulty swallowing, bleeding gums, poor gum color, misaligned teeth, poor tooth surface color, noticeable gaps between teeth, noticeable bad breath, difficulty chewing, poor bite, and shaky jaw. Institutions that hold information on the function, health status, and actual care of biological tissues in the user's oral and pharyngeal regions include medical institutions such as dental clinics, institutions that manage electronic medical record systems, and analytical evaluation institutions that analyze user specimen samples, and this information can be obtained by forming partnerships with these institutions in advance to exchange information.

The oral care-related information provided includes problems that can arise from using improper toothpaste, toothbrushes, and other products, as well as criteria and methods for selecting appropriate products, information on various oral care products (ingredients, problems that can arise from incorrect use and correct usage, etc.), specific optimal oral care methods for a set period of time (for example, one week), oral problems that arise from differences in age and gender, and among pregnant women, infants, and people requiring care, and how to prevent and deal with them, an introduction to the latest oral care research, basic knowledge about dentures and implants, common problems with dentures and how to prevent them, etc.

Information provided about the relationship between diet and care may include examples of problems caused by poor or unbalanced eating habits, the consumption or use of luxury items, and how to deal with them, information about the importance of chewing and problems that can arise when chewing disorders occur, preventative measures to make chewing disorders less likely to occur, information about the importance of bite alignment and problems that can arise when bite disorders occur, etc. It is also preferable to provide information about the relationship between overall health and oral hygiene.

In exchange for providing this information, the subject will obtain information on the subject's awareness and actual knowledge status without the user being aware of it as much as possible. Specifically, information is obtained from the user's selection history from a list of free services, or by the user inputting the information required for each service provided. If monitoring information is input in conjunction with product use, a data storage directory will be created for each subject. It is also preferable to perform user registration after product purchase and provide product after-sales service.

The subject general attribute information acquisition unit acquires general user attributes such as gender, age, date of birth, height, weight, area of residence, and occupation from individual terminals 2 or the external system server 4 that stores subject information.

The health conditions acquired by the subject information acquisition unit include information acquired from the sensor device serving as terminal 2, such as the frequency and number of teeth grinding events, obtained from an electromyography sensor attached to the temples or chin, which indicates the state of the jaw; physical conditions such as height, weight, body fat percentage, electrocardiogram, pulse wave, pulse rate, SpO2 (transcutaneous arterial oxygen saturation), hemoglobin concentration, body temperature, activity level, blood pressure, blood sugar level, and bone density, obtained from dedicated sensors; and calorie intake, obtained from a camera. Information acquired from institutional computers 3, such as those of medical institutions, health insurance and labor unions, and institutions that manage electronic medical record systems, includes the subject's health checkup results, blood donation eligibility and specimen test information, the type and frequency of health foods consumed, information on diseases currently being treated, the presence and type of allergies, and medication information.

The treatment history acquired by the subject information acquisition unit can include information declared by the subject, as well as information acquired from an external system server 4 used by medical institutions, health insurance and labor unions, and institutions that manage electronic medical record systems. Examples of information that can be obtained include past dental checkup history, past tartar removal history, whether or not fluoride application was performed and the date of treatment, whether or not scaling or root planing was performed and the date of treatment, whether or not dentures are worn and the location where they are worn, the date they were worn first, whether or not implants are worn and the location where they are worn, treatment information (caries treatment, periodontal disease treatment, etc.), oral bacterial serum antibody titer measurement information, occlusion status information, whether or not brushing instruction was given and the date of instruction, the presence of specific oral bacteria (for example, tests utilizing immune responses), the presence or absence of occult blood (for example, tests utilizing the catalytic action of hemoglobin or immune responses), the state of the user's oral flora, the type and amount of immunoglobulin in saliva, DNA/RNA analysis of oral mucosa and saliva, quantification of heparanase in saliva, quantification of female hormones in saliva, quantification of ammonia in saliva, quantification of leukocytes in saliva, quantification of tissue destruction markers such as LDH and MMP in saliva, and the type and amount of oxidative stress markers in saliva.

Similarly, examples of information about dietary habits acquired by the subject information acquisition unit include the number of usual meals, the usual start and duration of meals, and the contents of the meals. It is preferable that this information can be acquired automatically, without the subject having to declare it, using a dedicated device or the like. For example, for information about meal contents that is difficult to provide, it is preferable to use a method such as taking and sending photos of the meals, which are then analyzed by AI and converted into information about the meal contents. It is also more preferable to acquire as much information as possible about the subject's eating and drinking habits, such as the number of times they eat out, the contents of meals when they eat out, whether or not they have snacks and their contents, and the contents and times of ingestion of beverages consumed.

Similarly, the lifestyle habits acquired by the subject information acquisition unit are preferably automatically input to the support server 1 from various information acquisition devices via an information terminal owned by the subject. Examples of information sent from the information terminal to the support server 1 include lifestyle (smoking, drinking, preferences (e.g., frequent consumption of sweets)), daily activity diary, types of daily exercise, average exercise time for daily exercise, average bedtime and average wake-up time, and information related to sleep quality.

The useful information generation unit analyzes the latest and past information stored in the test information storage unit, subject information storage unit, and oral function information storage unit, which can grasp the function and health status of biological tissues in the oral cavity and pharyngeal region, the current state of care, and the current state of awareness and knowledge, based on the subject information stored in the subject information storage unit, and selects and generates information useful for maintaining and improving the insurer's oral health at the time the analyzed information is provided. The analysis can be performed based on a predetermined formula, such as multivariate analysis. It is also preferable to analyze past information and useful information provided in the past using machine learning, and generate the information based on inference. Any method, such as deep learning using neural networks, can be used for this machine learning.

The useful information generated by the useful information generating unit preferably includes one or more pieces of information selected from the following pieces of information (i) to (vi):
(i) Evaluation information and improvement proposals regarding the subject's oral care status;
(ii) general information on the level of functioning of the tissues in the oral-pharyngeal region, the state of oral hygiene, and the possible impact of the presence or absence of oral diseases and their severity on physical and mental health;
(iii) Information about the subject's current oral and pharyngeal condition and other possible risks to future oral health status, and methods for preventing and improving such risks;
(iv) Information about services to maintain and improve the subject's oral function;
(v) An evaluation of the subject's actual lifestyle, dietary and exercise habits, and the risks to future oral health that can be predicted from those habits, as well as information on how to improve those habits and support suggestions for maintaining and improving those habits;
(vi) Information about sleep behaviors or remedial services that may adversely affect the function or condition of the subject's oral and pharyngeal area.

The above describes embodiments of the present invention, but the present invention is not limited to these examples and can, of course, be embodied in various forms without departing from the spirit of the present invention.

1 Support server 2 Terminal 3 System-external computing device 4 System-external server 5 Terminal 10 Processing device 11 Storage means 12 Communication control unit

Claims (14)

A specimen test for predicting the oral health status of a subject, including a nucleic acid test related to bacteria and/or Candida present in the oral cavity and throat, and one or more tests selected from the group consisting of blood glucose level measurement, hemoglobin A1c level measurement, oxidized HDL level measurement, and high-sensitivity CRP test. Bacteria present in the oral cavity and throat include at least Porphyromonas g ingivalis , Treponema denticola , Tannerella forsythia , Prevotella intermedia , Aggregatibacter actinomycetemcomitans , Fusobacterium nucleatum , Streptococcus mutans , Streptococcus sobrinus , and Streptococcus downei. , Streptococcus rattus , Actinomyces naeslundii , Actinomyces viscosus , Actinomyces odontolyticus , Actinomyces oris , Streptococcus sanguinis , Streptococcus gordonii , Streptococcus oralis , Streptococcus mitis , Prevotella nigrescens , Porphyromonas pasteri , Veillonella dispar 2. The test sample of claim 1, wherein the sample contains one or more bacteria selected from the group consisting of: Veillonella parvula , Aggregatibacter actinomycetemcomitans , Corynebacterium matruchotii , and Streptococcus constellatus . The sample test according to claim 2, wherein the bacteria present in the oral cavity or throat include at least Porphyromonas gingivalis . The specimen test described in any one of claims 1 to 3 provides information about the subject's oral cavity in addition to the specimen test results. The specimen test described in claim 4, wherein the information relating to the subject's oral cavity includes at least information relating to oral health status, information relating to oral health risk factors, information relating to oral hygiene, and information relating to recommended oral care products. The specimen test described in claim 4, wherein the information regarding the subject's oral cavity includes information regarding dental health guidance. The specimen test according to claim 1, wherein the test sample to be subjected to nucleic acid testing is a blood sample drawn from a vein or a specimen test sample obtained by collection from the oral cavity, throat, or oral tissue. An oral care support system that uses nucleic acid test results information related to bacteria and/or Candida present in the oral cavity and throat and the information in (i) below to create information useful for improving or maintaining the subject's oral cavity in a healthy state, and provides the nucleic acid test results information and the created useful information to the person requesting the test and/or the subject.
(i) Blood test results including at least one or more of the following test items: blood glucose level measurement, hemoglobin A1c level measurement, oxidized HDL level measurement, and high-sensitivity CRP test An oral care support system that uses nucleic acid test result information related to bacteria and/or Candida present in the oral cavity and throat and the information in (i) and (ii) below to create information useful for improving or maintaining the oral cavity of a subject in a healthy state, and provides some or all of the nucleic acid test result information and the created useful information to the person requesting the test and/or the subject.
(i) Blood test results including at least one or more of the following test items: blood glucose level measurement, hemoglobin A1c level measurement, oxidized HDL level measurement, and high-sensitivity CRP test
(ii) Subject information including at least one or more of the following: the subject's own gender, age, height, weight, waist circumference, BMI, waist-to-hip ratio, general attribute information on the medical history of blood relatives, subjective information on oral and general health status, treatment history information, actual information on oral hygiene habits, dietary habits, lifestyle habits, exercise habits, drinking habits, and smoking habits, bedtime behavior information, and psychological state information. Bacteria present in the oral cavity and throat include at least Porphyromonas gingivalis , Treponema denticola , Tannerella forsythia , Prevotella intermedia , Aggregatibacter actinomycetemcomitans , Fusobacterium nucleatum , Streptococcus mutans , Streptococcus sobrinus , and Streptococcus downei. , Streptococcus rattus , Actinomyces naeslundii , Actinomyces viscosus , Actinomyces odontolyticus , Actinomyces oris , Streptococcus sanguinis , Streptococcus gordonii , Streptococcus oralis , Streptococcus mitis , Prevotella nigrescens , Porphyromonas pasteri , Veillonella dispar 10. The oral care support system according to claim 8 or 9, comprising one or more bacteria selected from the group consisting of Veillonella parvula , Aggregatibacter actinomycetemcomitans , Corynebacterium matruchotii , and Streptcoccus constellatus . 10. The oral care support system according to claim 8 or 9, wherein the bacteria present in the oral cavity or throat include at least two or more different strains of Porphyromonas gingivalis . The oral care support system of claim 8 or 9 further includes, as test items, one or more of the following evaluations: understanding and evaluation of oral function and oral condition using images or videos of the oral cavity; evaluation of oral function using videos including the head during chewing and/or vocalization and chewing sounds; and oral diadochokinesis. The oral care support system according to claim 8 or 9, further comprising one or more pieces of information about the oral cavity obtained using a sensor device as test items. The oral care support system of claim 8 or 9 stores some or all of the test results of the specimen test and information generated from the test results necessary for maintaining and improving the subject's oral cavity in a healthy state in an electronic medical record or a database used for the subject's health management, and uses the information to support medical procedures in the fields of dentistry and oral surgery and to support oral health management for the subject.