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BACKGROUND: The purpose of this study was to report the basic profile of the Miyagi Prefecture part of a repeated center-based survey during the second period (2nd period survey) of the Tohoku Medical Megabank Community-Based Cohort Study (TMM CommCohort Study), as well as the participants' characteristics based on their participation type in the baseline survey. METHODS: The 2nd period survey, conducted from June 2017 to March 2021, included participants of the TMM CommCohort Study (May 2013 to March 2016). In addition to the questionnaire, blood, urine, and physiological function tests were performed during the 2nd period survey. There were three main ways of participation in the baseline survey: Type 1, Type 1 additional, or Type 2 survey. The 2nd period survey was conducted in the same manner as the Type 2 survey, which was based on the community support center (CSC). RESULTS: In Miyagi Prefecture, 29,383 (57.7%) of 50,967 participants participated in the 2nd period survey. The participation rate among individuals who had visited the CSC was approximately 80%. Although some factors differed depending on the participation type in the baseline survey, the 2nd period survey respondents in the Type 1 and Type 2 survey groups at baseline had similar traits. CONCLUSIONS: The 2nd period survey of the TMM CommCohort Study provided detailed follow-up information. Following up on the health conditions of the participants will clarify the long-term effects of disasters and contribute to personalized prevention.
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PURPOSE: The purpose of this study is to investigate the effects of denture adhesives on masticatory performance via a 10-center, parallel, randomized, controlled trial of complete denture wearers in Japan. METHODS: The trial was conducted between September 2013 and October 2016. The inclusion criteria were complete edentulism, willingness to undergo new complete denture treatment, and willingness to return for recall treatment. The exclusion criteria were age 90 years or older, presence of severe systemic illness, inability to understand the questionnaires, wearing metal base complete dentures, denture adhesive user, wearing prosthetics for maxillofacial defects, wearing complete dentures with tissue conditioners, and severe xerostomia. Randomization of the powder-type denture adhesive (powder), cream-type denture adhesive (cream), and control (saline) groups was performed using a sealed envelope system. Masticatory performance was measured using color-changeable chewing gum. Intervention blinding was not feasible. RESULTS: Sixty-seven control, 69 powder, and 64 cream participants are analyzed using the intention-to-treat principle. The participants in all groups show significantly improved masticatory performance at post-intervention (paired t-test with Bonferroni correction P < 0.0001). However, no significant difference in masticatory performance is detected among the three groups (one-way analysis of variance). A significant negative correlation between pre- and post-changes in masticatory performance and intraoral condition scores is observed (Pearson's correlation coefficient, P < 0.0001). CONCLUSIONS: Although denture adhesives improved the masticatory performance of complete denture wearers, their clinical effects are comparable to those of saline solution. The use of denture adhesives is more effective in complete denture wearers with unsatisfactory intraoral conditions.
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Boca Edêntula , Perda de Dente , Humanos , Idoso de 80 Anos ou mais , Pós , Prótese Total , Goma de Mascar , MastigaçãoRESUMO
PURPOSE: This study aimed to determine the effects of denture adhesives on denture retention and occlusal force in complete denture wearers in a multicenter, randomized, parallel-group controlled trial. METHODS: Two hundred edentulous patients wearing complete dentures were allocated to three groups: powder-type denture adhesive, cream-type denture adhesive, and control (saline solution). Denture adhesives and saline solution were applied to the dentures for 4 days. The retentive force of the dentures and occlusal force were measured using a force transducer occlusal force meter at baseline and after 4 days of intervention. In addition to between-group comparisons, subgroup analyses of denture retention and occlusal force were performed based on the level of difficulty of the edentulism treatment. The levels were ranked as I (easy), II, III, and IV (difficult). RESULTS: Cream-type denture adhesives significantly improved the retentive force of the dentures (P<0.01) and occlusal force (P<0.05), with no significant differences between baseline and post-intervention forces in the powder-type denture adhesive and control groups. In within-group comparisons, cream-type denture adhesives improved both the retentive and occlusal forces at Level II (P<0.05), and powder-type denture adhesives improved the occlusal force at Level II (P<0.01). CONCLUSIONS: Application of cream-type denture adhesives effectively improves the denture retention and occlusal force in complete denture wearers with a moderate degree of difficulty during edentulism treatment.
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BACKGROUND: The Tohoku Medical Megabank Project Birth and Three-Generation Cohort Study was launched in 2013 to evaluate the complex interactions of genetic and environmental factors in multifactorial diseases. The present study describes the maternal baseline profile and perinatal data of participating mothers and infants. METHODS: Expectant mothers living in Miyagi Prefecture were recruited from obstetric facilities or affiliated centers between 2013 and 2017. Three sets of self-administered questionnaires were collected, and the medical records were reviewed to obtain precise information about each antenatal visit and each delivery. Biospecimens, including blood, urine, umbilical cord blood, and breast milk, were collected for the study biobank. The baseline maternal sociodemographic characteristics, results of screening tests, and obstetric outcomes were analyzed according to the maternal age group. RESULTS: A total of 23,406 pregnancies involving 23,730 fetuses resulted in 23,143 live births. Younger maternal participants had a tendency toward a higher incidence of threatened abortion and threatened premature labor, while older age groups exhibited a significantly higher rate of low lying placenta, placenta previa, gestational diabetes, and hypertensive disorders of pregnancy. CONCLUSIONS: The present study clearly shows the distribution of maternal baseline characteristics and the range of perinatal outcomes according to maternal age group. This cohort study can provide strategic information for creating breakthroughs in the pathophysiology of perinatal, developmental, and noncommunicable diseases by collaborative data visiting or sharing.
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Diabetes Gestacional , Idoso , Estudos de Coortes , Feminino , Humanos , Lactente , Idade Materna , Mães , Gravidez , Resultado da Gravidez/epidemiologiaRESUMO
To reveal gene-environment interactions underlying common diseases and estimate the risk for common diseases, the Tohoku Medical Megabank (TMM) project has conducted prospective cohort studies and genomic and multiomics analyses. To establish an integrated biobank, we developed an integrated database called "dbTMM" that incorporates both the individual cohort/clinical data and the genome/multiomics data of 157,191 participants in the Tohoku Medical Megabank project. To our knowledge, dbTMM is the first database to store individual whole-genome data on a variant-by-variant basis as well as cohort/clinical data for over one hundred thousand participants in a prospective cohort study. dbTMM enables us to stratify our cohort by both genome-wide genetic factors and environmental factors, and it provides a research and development platform that enables prospective analysis of large-scale data from genome cohorts.
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BACKGROUND: We established a community-based cohort study to assess the long-term impact of the Great East Japan Earthquake on disaster victims and gene-environment interactions on the incidence of major diseases, such as cancer and cardiovascular diseases. METHODS: We asked participants to join our cohort in the health check-up settings and assessment center based settings. Inclusion criteria were aged 20 years or over and living in Miyagi or Iwate Prefecture. We obtained information on lifestyle, effect of disaster, blood, and urine information (Type 1 survey), and some detailed measurements (Type 2 survey), such as carotid echography and calcaneal ultrasound bone mineral density. All participants agreed to measure genome information and to distribute their information widely. RESULTS: As a result, 87,865 gave their informed consent to join our study. Participation rate at health check-up site was about 70%. The participants in the Type 1 survey were more likely to have psychological distress than those in the Type 2 survey, and women were more likely to have psychological distress than men. Additionally, coastal residents were more likely to have higher degrees of psychological distress than inland residents, regardless of sex. CONCLUSION: This cohort comprised a large sample size and it contains information on the natural disaster, genome information, and metabolome information. This cohort also had several detailed measurements. Using this cohort enabled us to clarify the long-term effect of the disaster and also to establish personalized prevention based on genome, metabolome, and other omics information.
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Terremotos/estatística & dados numéricos , Interação Gene-Ambiente , Angústia Psicológica , Adulto , Doenças Cardiovasculares/epidemiologia , Estudos de Coortes , Pesquisa Participativa Baseada na Comunidade , Desastres , Feminino , Genoma , Humanos , Incidência , Japão/epidemiologia , Estilo de Vida , Masculino , Metaboloma , Pessoa de Meia-Idade , Neoplasias/epidemiologia , Inquéritos e Questionários , Adulto JovemRESUMO
Purpose To investigate the difference in improvement of oral health-related quality of life (OHR-QoL) depending on the oral and denture conditions of a complete denture wearer when using a cream or powder type denture adhesive in a 10-center parallel randomized clinical trial.Methods Two hundred edentulous subjects who wore complete dentures were allocated to each of the three groups according to denture adhesive type: cream, powder, and control (saline solution). The materials were applied to the mucosal surface of the dentures for 4 days, and baseline data and data after the intervention were collected. OHR-QoL was assessed using the Japanese version of the modified Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT-J) scale for outcome. Multivariate analysis was used to investigate improvements in OHR-QoL according to participant characteristics among complete denture wearers using these materials.Results OHIP-EDENT-J scores were significantly decreased in all groups after the intervention (p < 0.05); however, there were no statistically significant differences among the groups. Multiple logistic regression analysis revealed a significant association between the vertical height of the maxillary and mandibular alveolar ridge and OHIP-EDENT-J scores in the cream-type denture adhesive group. In contrast, there were no significant association between participant characteristics and OHIP-EDENT-J scores in the powder-type adhesive and control groups.Conclusions The use of denture adhesives could improve OHR-QoL for complete denture wearers. The cream-type denture adhesives may be expected to improve OHR-QoL in patients with poor residual ridge conditions compared with patients with good residual ridge conditions.
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Boca Edêntula , Qualidade de Vida , Prótese Total , Humanos , Análise Multivariada , Saúde Bucal , Satisfação do Paciente , Inquéritos e QuestionáriosRESUMO
In order to assess the long-term impact of the Great East Japan Earthquake on the oral health of disaster victims and to evaluate gene-environmental interactions in the development of major oral diseases and oral-systemic associations, the oral part of two large-scale genome cohort studies by the Tohoku Medical Megabank Organization (ToMMo), including the Community-based cohort (CommCohort) study and the Birth and Three-Generation cohort (BirThree) study, have been conducted. The study population comprised 32,185 subjects, including 16,886 participants in the CommCohort study and 15,299 participants in the BirThree cohort study, recruited from 2013 to 2017. The oral studies consist of a questionnaire regarding oral hygiene behavior, clinical examinations by dentists, and oral plaque and saliva sampling for microbiome analyses, which were carried out at seven community support centers in Miyagi prefecture. The median age of all participants was 55.0 years, and 66.1% of participants were women. Almost all participants reported that they brushed their teeth more than once a day. The median number of present teeth was 27.0, and the decayed, missing and filled tooth number was 16.0, with a significant difference according to age and sex. The median periodontal pocket and clinical attachment level was 2.48 mm and 4.00 mm, respectively. Periodontal parameters increased significantly according to age, except for the accumulation of dental calculus. The oral part of these extensive cross-sectional studies provides a unique and important platform for future studies on oral health and diseases that elicit through interactions with systemic diseases, lifestyles, life events and genetic backgrounds, and contributes to researches clarifying the long-term effects of disasters on oral health.
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Cárie Dentária/epidemiologia , Vítimas de Desastres/estatística & dados numéricos , Terremotos , Saúde Bucal/estatística & dados numéricos , Doenças Periodontais/epidemiologia , Adulto , Idoso , Bancos de Espécimes Biológicos/organização & administração , Bancos de Espécimes Biológicos/tendências , Estudos de Coortes , Estudos Transversais , Cárie Dentária/diagnóstico , Cárie Dentária/patologia , Diagnóstico Bucal/métodos , Diagnóstico Bucal/estatística & dados numéricos , Diagnóstico Bucal/tendências , Desastres , Feminino , Humanos , Japão/epidemiologia , Masculino , Pessoa de Meia-Idade , Saúde Bucal/normas , Doenças Periodontais/diagnóstico , Doenças Periodontais/patologia , Inquéritos e QuestionáriosRESUMO
A baseline oral microbiome study of the Tohoku Medical Megabank Organization (TMM) was planned to characterize the profile of the oral microbiome in the Japanese population. The study also aimed to clarify risk factors for multifactorial diseases by integrated analysis of the oral microbiome and host genome/omics information. From 2013 to 2016, we collected three types of oral biospecimens, saliva, supragingival plaque, and tongue swab, from a total of 25,101 participants who had a dental examination in TMM. In this study, we used two independent cohorts; the Community-Based Cohort and Birth and Three-Generation Cohort as discovery and validation cohorts, respectively, and we selected participants examined by a single dentist. We found through the 16S ribosomal RNA gene sequencing analysis of 834 participants of the Community-Based Cohort Study that there are differences in the microbial composition and community structure between saliva and plaque. The species diversities in both saliva and plaque were increased in correlation with the severity of periodontal disease. These results were nicely reproduced in the analysis of 455 participants of the Birth and Three-Generation Cohort Study. In addition, strong positive and negative associations of microbial taxa in both plaque and saliva with periodontitis-associated biofilm formation were detected by co-occurrence network analysis. The classes Actinobacteria and Bacilli, including oral health-associated bacterial species, showed a positive correlation in saliva. These results revealed differences in microbial composition and community structure between saliva and plaque and a correlation between microbial species and the severity of periodontal disease. We expect that the large database of the oral microbiome in the TMM biobank will help in the discovery of novel targets for the treatment and prevention of oral diseases, as well as for the discovery of therapeutic and/or preventive targets of systemic diseases.
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Microbiota , Estudos de Coortes , Humanos , Estudos Prospectivos , RNA Ribossômico 16S/genética , SalivaRESUMO
PURPOSE: The purpose of this study was to investigate the effect of denture adhesives on oral moisture in a 10-center parallel randomized clinical trial. METHODS: Two hundred edentulous subjects wearing complete dentures were allocated into three groups: cream-type adhesive, powder-type adhesive and control groups. The adhesives (and saline solution in the control group) were applied to the mucosal surface of the dentures for 4 days, and baseline data and data after the intervention for eight meals over 4 days were obtained. For the main outcome, oral moisture was measured with a moisture checking device. Secondary outcomes were denture satisfaction, masticatory performance, denture retention, and occlusal force. In addition to between-group and within-group comparisons of oral moisture, investigations for secondary outcomes were undertaken in subgroups classified according to the degree of oral moisture at baseline (normal subgroup and dry mouth subgroup). Intention-to-treat analysis was also performed. RESULTS: Between-group and within-group comparisons of oral moisture showed no significant differences. The cream-type and powder-type denture adhesives were significantly effective in the dry mouth group for denture satisfaction ratings of ability to masticate, stability, retention, and comfort of mandibular dentures (p<0.05). The masticatory performance and retentive force of the dry mouth denture adhesive using groups were significantly improved after intervention (p<0.05). CONCLUSIONS: The oral moisture of complete denture wearers was not influenced by the use of denture adhesives. Our findings showed that denture adhesives improved subjective denture satisfaction, masticatory performance, and retention for complete denture patients with oral dryness.
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Cimentos Dentários , Boca Edêntula , Retenção de Dentadura , Prótese Total , Humanos , MastigaçãoRESUMO
PURPOSE: This study aimed to investigate the relationship between the bilateral maximum occlusal force (MOF) of full dental arches and all-cause mortality in a group of community-dwelling older males and females in Japan. METHODS: This 13-year prospective cohort study was conducted among 815 older adults (395 male and 420 female) aged 70 years or over (mean age ± standard deviation: 75.1 ± 4.5 years). Bilateral MOF in the intercuspal position was recorded with horseshoe-shaped pressure-sensitive film. Participants were grouped by gender into tertiles according to MOF. Demographic variables, chronicity, comorbidity, physical status, cognitive and psychological status, social functioning, and blood chemistry data were also assessed. Information regarding all-cause mortality and migration was obtained from the Sendai Municipal Authority. Cox proportional hazard modeling was performed to assess all-cause mortality during the follow-up period. RESULTS: In total, 159 male and 109 female participants died over a median 12.9-year follow-up period, and the cumulative mortality significantly increased with lower MOF in both males and females. The multivariate Cox proportional hazard model demonstrated a significant increase in the risk of all-cause mortality associated with lower tertiles of MOF, relative to the upper tertile in males (hazard ratio: 1.62; 95% confidence interval: 1.05-2.51) and females (hazard ratio: 1.94; 95% confidence interval: 1.10-3.56). CONCLUSIONS: There was a significant and independent association of bilateral MOF with all-cause mortality in community-dwelling elderly males and females in Japan. These findings suggested that maintenance of oral functioning contributes to general health.
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Força de Mordida , Vida Independente , Idoso , Comorbidade , Feminino , Humanos , Japão , Masculino , Estudos ProspectivosRESUMO
Background: The aim of this double-blind randomized cross-over trial was to evaluate the effect of oral intake of glucosylceramide extracted from pineapple on oral moisture and xerostomia symptoms. Methods: Sixteen participants who had xerostomia symptoms were randomly allocated into two groups. One group received, as test samples, tablets containing glucosylceramide extracted from pineapple (GCP) followed by placebo tablets. The other group received the test samples in the reverse order. Participants were instructed to take tablets of the first test sample once a day (after breakfast) for two consecutive weeks. Then, after a washout period of four weeks, participants were instructed to take the other test sample for two consecutive weeks. The oral moisture level of the lingual mucosa, xerostomia symptoms, and the number of fungiform papillae was evaluated. Results: The oral moisture significantly increased, and the visual analog scale (VAS) of "How is the dryness of your mouth?" significantly improved after GCP tablets intake and not after placebo tablets intake. The number of fungiform papillae was not significantly different following the intake of GCP tablets or placebo tablets. Conclusion: Results suggested that oral intake of GCP may improve the moisture level and xerostomia symptoms.
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Ananas/química , Frutas/química , Glucosilceramidas/administração & dosagem , Extratos Vegetais/administração & dosagem , Xerostomia/tratamento farmacológico , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Estudos Cross-Over , Método Duplo-Cego , Glucosilceramidas/efeitos adversos , Glucosilceramidas/isolamento & purificação , Humanos , Japão , Extratos Vegetais/efeitos adversos , Extratos Vegetais/isolamento & purificação , Estudos Prospectivos , Recuperação de Função Fisiológica , Comprimidos , Fatores de Tempo , Resultado do Tratamento , Xerostomia/diagnóstico , Xerostomia/fisiopatologiaRESUMO
Personalized healthcare (PHC) based on an individual's genetic make-up is one of the most advanced, yet feasible, forms of medical care. The Tohoku Medical Megabank (TMM) Project aims to combine population genomics, medical genetics and prospective cohort studies to develop a critical infrastructure for the establishment of PHC. To date, a TMM CommCohort (adult general population) and a TMM BirThree Cohort (birth+three-generation families) have conducted recruitments and baseline surveys. Genome analyses as part of the TMM Project will aid in the development of a high-fidelity whole-genome Japanese reference panel, in designing custom single-nucleotide polymorphism (SNP) arrays specific to Japanese, and in estimation of the biological significance of genetic variations through linked investigations of the cohorts. Whole-genome sequencing from >3,500 unrelated Japanese and establishment of a Japanese reference genome sequence from long-read data have been done. We next aim to obtain genotype data for all TMM cohort participants (>150,000) using our custom SNP arrays. These data will help identify disease-associated genomic signatures in the Japanese population, while genomic data from TMM BirThree Cohort participants will be used to improve the reference genome panel. Follow-up of the cohort participants will allow us to test the genetic markers and, consequently, contribute to the realization of PHC.
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Povo Asiático/genética , Genética Médica/tendências , Genoma Humano/genética , Genômica , Medicina de Precisão/tendências , Estudos de Coortes , Feminino , Humanos , Japão , Masculino , Pessoa de Meia-Idade , Polimorfismo de Nucleotídeo Único/genética , Padrões de ReferênciaRESUMO
PURPOSE: The purpose of this study was to examine whether the status of dentition is associated with incident functional disability in elderly people. METHODS: This prospective cohort study targeted community-dwelling Japanese adults of age ≥70 years (n=838). Participants were classified into the following four groups in accordance with Miyachi's Triangular Classification, which represents the status of dentition on the basis of numbers of remaining teeth and occlusal supports: Zone A, ≥10 occlusal supports; Zone B, 5-9 occlusal supports; Zone D, ≤4 occlusal supports and ≥11 remaining teeth and Zone C, ≤10 remaining teeth. Incident functional disability was defined by the first certification of long-term care insurance in Japan. Data regarding age, sex, body mass index, medical history, smoking, alcohol consumption, education, depressive symptoms, cognitive impairment, social support, history of fall, and subjective masticatory ability were collected. RESULTS: During follow-up for 5185 person-years, 305 participants experienced functional disability. Considering the follow-up data of ≥3 years from baseline, participants in Zones C (hazard ratio [HR], 1.98; 95 % confidence interval [CI], 1.26-3.11) and D (HR, 2.50; 95 %CI, 1.54-4.05) were found to be more likely to develop functional disability than those in Zone A (p for trend=0.002). CONCLUSIONS: Status of dentition was associated with incident functional disability in an elderly Japanese population. The findings of this study suggest that maintenance of remaining teeth and retention of occlusal supports contribute to the prevention of functional disability.
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Dentição , Pessoas com Deficiência/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Povo Asiático , Estudos de Coortes , Feminino , Humanos , Japão/epidemiologia , Masculino , Estudos Prospectivos , Gestão de RiscosRESUMO
Colorectal cancer (CRC) is the fourth leading cause of cancer mortality worldwide. Genome-wide association studies (GWAS) identified more than 50 CRC loci. However, most of the previous studies were conducted in European population, and host genetic factors among Japanese population are largely remained to be identified. To identify novel loci in the Japanese population, here, we performed a large-scale GWAS using 6692 cases and 27 178 controls followed by a replication analysis using more than 11 000 case-control samples. We found the significant association of 10 loci (P < 5 × 10-8), including 2 novel loci on 16q24.1 (IRF8-FOXF1, rs847208, P = 3.15 × 10-9 and odds ratio = 1.107 with 95% confidence interval (CI) of 1.071-1.145) and 20q13.12 (TOX2, rs6065668, P = 4.47 × 10-11 and odds ratio = 0.897 with 95% CI of 0.868-0.926). Moreover, 35 previously reported single nucleotide polymorphisms (SNPs) in 24 regions were validated in the Japanese population (P < 0.05) with the same risk allele as in the previous studies. SNP rs6065668 was significantly associated with TOX2 expression in the sigmoid colon. In addition, nucleotide substitutions in the regulatory region of TOX2 were predicted to alter the binding of several transcription factors, including KLF5. Our findings elucidate the important role of genetic variations in the development of CRC in the Japanese population.
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Neoplasias Colorretais/genética , Predisposição Genética para Doença/genética , Polimorfismo de Nucleotídeo Único/genética , Idoso , Alelos , Povo Asiático/genética , Estudos de Casos e Controles , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Razão de Chances , Fatores de RiscoRESUMO
OBJECTIVES: To examine whether number of remaining teeth and regular dental care affect incident functional disability in elderly Japanese adults. DESIGN: Prospective cohort study. SETTING: Tsurugaya district, Sendai, Japan. PARTICIPANTS: Community-dwelling individuals aged 70 and older (N = 834). MEASUREMENTS: The outcome measurement was incident functional disability, defined as first certification of long-term care insurance in Japan, which is determined on the basis of a strictly established uniform nationwide standard. During a median follow-up of 7.9 years (interquartile range 4.8-7.9 years), information on long-term care insurance was obtained from the Sendai Municipal Authority. Oral health was assessed according to number of remaining teeth and presence or absence of regular dental care. Data were also collected on age, sex, body mass index, medical history, smoking, alcohol consumption, duration of education, depressive symptoms, cognitive impairment, physical functioning, and social support. RESULTS: Participants with 10 to 19 teeth (adjusted hazard ratio (aHR) = 1.42, 95% confidence interval (CI) = 1.03-1.94), one to nine teeth (aHR = 1.46, 95% CI = 1.04-2.03), and no teeth (aHR = 1.49, 95% CI = 1.03-2.14) were more likely to develop functional disability than those with 20 or more teeth. There was no significant difference in risk of functional disability between participants with 20 or more teeth and those with zero to 19 teeth who were receiving regular dental care, whereas those with zero to 19 teeth without regular dental care had a significantly greater risk of functional disability than those with 20 or more teeth (HR = 1.46, 95% CI = 1.11-1.92). CONCLUSION: Tooth loss was associated with greater risk of functional disability in community-dwelling elderly Japanese. Regular dental care might moderate the risk of functional disability in elderly individuals with missing teeth.
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Assistência Odontológica para Idosos/estatística & dados numéricos , Avaliação da Deficiência , Avaliação Geriátrica , Perda de Dente/epidemiologia , Idoso , Feminino , Humanos , Incidência , Seguro de Assistência de Longo Prazo , Japão/epidemiologia , Masculino , Saúde Bucal , Estudos Prospectivos , Fatores de RiscoRESUMO
BACKGROUND: Denture adhesives, characterized as medical products in 1935 by the American Dental Association, have been considered useful adjuncts for improving denture retention and stability. However, many dentists in Japan are hesitant to acknowledge denture adhesives in daily practice because of the stereotype that dentures should be inherently stable, without the aid of adhesives. The aim of this study is to verify the efficacy of denture adhesives to establish guidelines for Japanese users. The null hypothesis is that the application of denture adhesives, including the cream and powder types, or a control (isotonic sodium chloride solution) would not produce different outcomes nor would they differentially improve the set outcomes between baseline and day 4 post-application. METHODS: This ten-center, randomized controlled trial with parallel groups is ongoing. Three hundred edentulous patients with complete dentures will be allocated to three groups (cream-type adhesive, powder-type adhesive, and control groups). The participants will wear their dentures with the denture adhesive for 4 days, including during eight meals (three breakfasts, two lunches, and three dinners). The baseline measurements and final measurements for the denture adhesives will be performed on the first day and after breakfast on the fourth day. The primary outcome is a general satisfaction rating for the denture. The secondary outcomes are denture satisfaction ratings for various denture functions, occlusal bite force, resistance to dislodgement, masticatory performance, perceived chewing ability, and oral health-related quality of life. Between-subjects comparisons among the three groups and within-subjects comparisons of the pre- and post-intervention measurements will be performed. Furthermore, a multiple regression analysis will be performed. The main analyses will be based on the intention-to-treat principle. A sample size of 100 subjects per group, including an assumed dropout rate of 10 %, will be required to achieve 80 % power with a 5 % alpha level. DISCUSSION: This randomized clinical trial will provide information about denture adhesives to complete denture wearers, prosthodontic educators, and dentists in Japan. We believe this new evidence on denture adhesive use from Japan will aid dentists in their daily practice even in other countries. TRIAL REGISTRATION: ClinicalTrials.gov NCT01712802 . Registered on 17 October 2012.
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Adesivos , Protocolos Clínicos , Prótese Total , Guias de Prática Clínica como Assunto , HumanosRESUMO
The Great East Japan Earthquake (GEJE) and resulting tsunami of March 11, 2011 gave rise to devastating damage on the Pacific coast of the Tohoku region. The Tohoku Medical Megabank Project (TMM), which is being conducted by Tohoku University Tohoku Medical Megabank Organization (ToMMo) and Iwate Medical University Iwate Tohoku Medical Megabank Organization (IMM), has been launched to realize creative reconstruction and to solve medical problems in the aftermath of this disaster. We started two prospective cohort studies in Miyagi and Iwate Prefectures: a population-based adult cohort study, the TMM Community-Based Cohort Study (TMM CommCohort Study), which will recruit 80 000 participants, and a birth and three-generation cohort study, the TMM Birth and Three-Generation Cohort Study (TMM BirThree Cohort Study), which will recruit 70 000 participants, including fetuses and their parents, siblings, grandparents, and extended family members. The TMM CommCohort Study will recruit participants from 2013 to 2016 and follow them for at least 5 years. The TMM BirThree Cohort Study will recruit participants from 2013 to 2017 and follow them for at least 4 years. For children, the ToMMo Child Health Study, which adopted a cross-sectional design, was also started in November 2012 in Miyagi Prefecture. An integrated biobank will be constructed based on the two prospective cohort studies, and ToMMo and IMM will investigate the chronic medical impacts of the GEJE. The integrated biobank of TMM consists of health and clinical information, biospecimens, and genome and omics data. The biobank aims to establish a firm basis for personalized healthcare and medicine, mainly for diseases aggravated by the GEJE in the two prefectures. Biospecimens and related information in the biobank will be distributed to the research community. TMM itself will also undertake genomic and omics research. The aims of the genomic studies are: 1) to construct an integrated biobank; 2) to return genomic research results to the participants of the cohort studies, which will lead to the implementation of personalized healthcare and medicine in the affected areas in the near future; and 3) to contribute the development of personalized healthcare and medicine worldwide. Through the activities of TMM, we will clarify how to approach prolonged healthcare problems in areas damaged by large-scale disasters and how useful genomic information is for disease prevention.
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Medicina de Desastres/organização & administração , Desastres , Terremotos , Tsunamis , Objetivos , Humanos , Japão , Estudos ProspectivosRESUMO
The rapid improvement of next-generation sequencing performance now enables us to analyze huge sample sets with more than ten thousand specimens. However, DNA extraction can still be a limiting step in such metagenomic approaches. In this study, we analyzed human oral microbes to compare the performance of three DNA extraction methods: PowerSoil (a method widely used in this field), QIAsymphony (a robotics method), and a simple boiling method. Dental plaque was initially collected from three volunteers in the pilot study and then expanded to 12 volunteers in the follow-up study. Bacterial flora was estimated by sequencing the V4 region of 16S rRNA following species-level profiling. Our results indicate that the efficiency of PowerSoil and QIAsymphony was comparable to the boiling method. Therefore, the boiling method may be a promising alternative because of its simplicity, cost effectiveness, and short handling time. Moreover, this method was reliable for estimating bacterial species and could be used in the future to examine the correlation between oral flora and health status. Despite this, differences in the efficiency of DNA extraction for various bacterial species were observed among the three methods. Based on these findings, there is no "gold standard" for DNA extraction. In future, we suggest that the DNA extraction method should be selected on a case-by-case basis considering the aims and specimens of the study.