Effect of denture adhesives on masticatory performance: Multicenter randomized controlled trial.

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.

Effective use of an extraoral vacuum in preventing the dispersal of particulate matter from metal dental materials.

OBJECTIVES: When dentists adjust prostheses at the dental chairside, particulate matter (PM) from the dental material is dispersed. Little is known about the effective use of an extraoral vacuum (EOV) in preventing PM dispersal. This study aimed to evaluate the effective use of an EOV in preventing the dispersal of metal PM in dental offices. METHODS: The following experimental conditions were planned: the distance from the EOV to the metallic materials (50, 100, 150, and 200 mm), the horizontal angle between the long axis of the micromotor handpiece and EOV (0°, 45°, and 90°), and the operating time of the EOV (during grinding, during grinding and 1 min thereafter, during grinding and the preceding 1 min, 1 min before and after grinding, and during grinding). Carborundum and silicone points were used for grinding and PM dispersal. Diameters (0.3, 0.5, 1.0, and 3.0 µm) were measured using a laser particle counter. RESULTS: Depending on the instrument used to grind, there were undetectable PMs of different diameters (Carborundum point: 0.3 and 0.5 µm, Silicone point: 0.3 µm). PMNs were reduced as the distance from the EOV to metal materials decreased. Operating the EOV before grinding along the long axis of the micromotor handpiece was effective in reducing the PMNs. CONCLUSION: PMNs dispersed when grinding metals were effectively reduced by positioning the EOV closer to the grinding surface (within 150 mm) along the long axis of the micromotor handpiece and operating the EOV before grinding.

Can Measurement of Ultrasonic Echo Intensity Predict Physical Frailty in Older Adults?

Echo intensity (EI) of the tongue in ultrasonography is an easy and quantitative assessment of tongue function. Elucidating the relationship between EI and frailty, is expected to aid in the early detection of frailty and oral hypofunction in older adults. We assessed tongue function and frailty in older outpatients visiting a hospital. The subjects were 101 individuals aged 65 or older (35 men and 66 women, mean age 76.4 ± 7.0 years). Tongue pressure and EI were measured as assessments of tongue function and grip strength, and Kihon Checklist (KCL) scores were measured as assessments of frailty. In women, a significant correlation was not found between the mean EI and grip strength, whereas a significant correlation was noted between each score of the KCL and the mean EI; the scores increased as the mean EI increased. A significant positive correlation was found between tongue pressure and grip strength, but no significant correlation was observed between tongue pressure and the KCL scores. In men, no significant correlation was found between tongue assessments and frailty, except for a significant positive correlation between tongue pressure and grip strength. The results of this study suggest that EI of the tongue is positively associated with physical frailty in women and may be useful for early detection of physical frailty status.

Effects of denture adhesives on denture retention and occlusal forces in complete denture wearers: A multicenter, randomized controlled trial.

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.

Prosthodontic treatment can improve the ingestible food profile in Japanese adult outpatients.

PURPOSE: To investigate the effect of prosthodontic treatment on the ingestible food profile in adult Japanese outpatients, and to identify the related risk factors that can deteriorate the profile. METHODS: The participants were 277 outpatients who visited university-based specialty clinics in Japan for prosthodontic treatment. The demographic data, number of present teeth assessed via intraoral examination, and oral health-related quality of life assessed by the total Oral Health Impact Profile (OHIP-J54) scores of all participants were recorded before treatment. Ingestible food profile score (IFS) was recorded using a validated food intake questionnaire. Eligible participants who answered the questionnaire before and after treatment were categorized into five groups based on the prosthodontic treatments they received (i.e., crowns, bridges, removable partial dentures, removable complete dentures, and removable complete and partial dentures). RESULTS: Multivariate analysis of covariance revealed a statistically significant main effect of prosthodontic intervention (time course: before and after treatment) on mean IFS (P=0.035, F=4.526), even after adjusting for covariates (age, number of present teeth, and treatment modality). Multiple linear regression analysis revealed that the low number of present teeth (r=0.427, P<0.001) and a high OHIP-J54 total score (r=-0.519, P<0.001) of the patients at the baseline were significantly associated with their baseline IFSs, even after adjusting for confounding variables. CONCLUSIONS: The findings of this multicenter follow-up study indicate the importance of prosthodontic rehabilitation in improving patients' ingestible food profiles.

Measurement of ultrasonic echo intensity predicts the mass and strength of the tongue muscles in the elderly.

PURPOSE: The purpose of this study was to investigate the relationship between the echo intensity (EI) on ultrasound images of the tongue, tongue thickness, and tongue pressure to examine the effectiveness of EI measurement for assessing the tongue function. METHODS: A total of 100 elderly outpatients were enrolled. Tongue thickness and EI were measured using ultrasonography. The distance from mylohyoid muscle surface to dorsal surface of the tongue was measured for tongue thickness. Subsequently, this area was vertically divided into four areas: top of tongue dorsal side (DT), bottom of tongue dorsal side (DB), top of basal tongue side (BT), and bottom of basal tongue side (BB), and the EI was measured in each area. RESULTS: The mean EIs of DT and DB were lower than those of BT and BB. In the three areas apart from BB, the EI decreased with an increase in tongue thickness. In particular, a significant correlation between the EI in DB and tongue thickness was found. In all areas, the EI decreased with an increase in tongue pressure. CONCLUSION: The results of this study suggested that the measurement of EI could be an important indicator for assessing the tongue function in the elderly.

Multivariate analysis reveals oral health-related quality of life of complete denture wearers with denture adhesives: a multicenter randomized controlled trial.

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.

Does Masticatory Ability Contribute to Nutritional Status in Older Individuals?

Mastication plays a primary role in the process of eating. Hence, compromised masticatory ability may affect the nutrition and quality of life, which are particularly important concerns among older individuals. It remains unclear how is the masticatory ability assessed regarding the nutritional status. We examined the effect of various oral factors on three masticatory ability tests conducted among older individuals. A total of 100 older individuals were enrolled in this study. Body mass index (BMI) as an indicator of nutritional status; and age, sex, and the number of occlusal and molar occlusal supports as clinical attributes were recorded. Three masticatory ability tests (masticatory efficiency, masticatory score, and satisfaction with mastication) were conducted, and tongue pressure, cheek pressure, and occlusal force were assessed as oral functions. A significant but weak correlation was found between masticatory efficiency and the masticatory score, but not between masticatory efficiency and satisfaction score. Objective masticatory efficiency was strongly associated with objective oral factors, whereas subjective assessments of masticatory ability (masticatory score and satisfaction score) were not. Furthermore, BMI was significantly associated with subjective assessments of masticatory ability but not with objective masticatory efficiency. Both subjective and objective assessments of masticatory ability, along with considerations of nutritional formulations, are required for the maintenance and improvement of nutritional status in older individuals.

Reliability of Screening Methods to Diagnose Oral Dryness and Evaluate Saliva Secretion.

In this study, we evaluated the reliability and reproducibility of widely implemented salivary flow rate and oral dryness tests. In experiment 1, twenty young and healthy Japanese participants volunteered to participate. For each participant, the oral moisture (OM) level, unstimulated whole saliva volume (U-WSV), and stimulated whole saliva volume (S-WSV) were measured at the same time on two separate days. In experiment 2, twenty-seven patients who were over 65 years of age volunteered to participate. The OM level and U-WSV were measured at the same time on two separate days. In Experiment 1, the intra-class correlation coefficients (ICCs) corresponding to the S-WSV, U-WSV, and OM level were 0.23, 0.28, and 0.16, respectively, for the young participants. In Experiment 2, the ICCs corresponding to the U-WSV/spitting and OM level were 0.83 and 0.12, respectively, for the older participants. The results of Bland-Altman analysis confirmed the absence of systematic error, with the exception of the OM level results in Experiment 2, which indicated systematic bias. In conclusion, we believe that there is currently no consistent and reliable screening test for assessing salivary flow rate and oral dryness, although the spitting test was determined to be highly reliable.

Effect of denture adhesives on oral moisture: A multicenter randomized controlled trial.

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.

The Geniohyoid Muscle Directly Affects Masticatory Function: Evaluation with Decision-Tree Analysis.

PURPOSE: To clarify the effect of geniohyoid (GH) muscle morphology and related function on masticatory ability using a decision-tree analysis. MATERIALS AND METHODS: A total of 103 participants were enrolled. A cross-sectional area (CSA) of the GH muscle, neck circumference, body mass index, tongue pressure, jaw opening strength, and masticatory ability score were measured. The CSA of the GH muscle was selected as an independent variable for the first layer of the decision tree, with masticatory score as the dependent variable. RESULTS AND CONCLUSION: These data suggest that the CSA of the GH muscle may have a large impact on the masticatory ability score when evaluating masticatory ability.

Oral hypofunction in the older population: Position paper of the Japanese Society of Gerodontology in 2016.

BACKGROUND: There is growing international interest in identifying the effects of ageing on oral health and on appropriate strategies for managing oral disorders. The Japanese Society of Gerodontology (JSG), as the official representative of researchers and clinicians interested in geriatric dentistry in Japan, makes several recommendations on the concept of "oral hypofunction." AIMS: This study proposes diagnostic criteria and management strategies to reduce the risk of oral hypofunction among older people. CONCEPTUAL FRAMEWORK: We define oral hypofunction as a presentation of 7 oral signs or symptoms: oral uncleanness; oral dryness; decline in occlusal force; decline in motor function of tongue and lips; decline in tongue pressure; decline in chewing function; and decline in swallowing function. The criteria of each symptom were determined based on the data of previous studies, and oral hypofunction was diagnosed if the criteria for 3 or more signs or symptoms were met. CONCLUSIONS: We recommend that more evidence should be gathered from clinical studies and trials to clarify our diagnostic criteria and management strategies.

A multi-centered epidemiological study evaluating the validity of the treatment difficulty indices developed by the Japan Prosthodontic Society.

PURPOSE: The Japan Prosthodontic Society developed a multi-axis assessment protocol to evaluate the complex variations in patients who need prosthodontic care, and to classify the level of treatment difficulty. A previous report found the protocol to be sufficiently reliable. The purpose of this multi-center cohort study was to evaluate the validity of this multi-axis assessment protocol. METHODS: The treatment difficulty was evaluated using the multi-axis assessment protocol before starting prosthodontic treatment. The time required for active prosthodontic treatment, medical resources such as treatment cost, and changes in the oral health-related QOL before and after treatment, were evaluated after treatment completion. The construct validity of this protocol was assessed by the correlation between the dentist's pre-operative subjective assessment of the treatment difficulty, and the level of difficulty determined by this protocol. The predictive validity was assessed estimating the correlations between a "comprehensive level of treatment difficulty" based on the four axes of this protocol and total treatment cost, total treatment time, and changes in the oral health-related QOL before and after treatment. RESULTS: The construct validity of this protocol was well documented except for psychological assessment. Regarding the predictive validity, the comprehensive level of treatment difficulty assessed before treatment was significantly correlated with the three surrogate endpoints known to be related to the treatment difficulty (total treatment cost, treatment time, and improvement in the oral health-related QOL). To further clarify the validity of the protocol according to patients' oral condition, a subgroup analysis by defects was performed. Analyses revealed that treatment difficulty assessment before treatment was significantly related to one or two surrogate endpoints in the fully edentulous patients and the partially edentulous patients. No significant relationship was observed in the patients with mixture of full/partial edentulism and the patients with teeth problems, possibly due to the small sample size in these groups. CONCLUSION: This study revealed that the multi-axis assessment protocol was sufficiently valid to predict the level of treatment difficulty in prosthodontic care in patients with fully edentulous defects and with partially edentulous defects.

Antifungal and Mechanical Properties of Tissue Conditioner Containing Plant-Derived Component: An In Vitro Study.

PURPOSE: To evaluate the antifungal activity and mechanical properties of a novel antifungal tissue conditioner containing Juncus powder. MATERIALS AND METHODS: Juncus powder was mixed with GC tissue conditioner at concentrations of 2.5%, 5.0%, and 10.0% by mass. The cylindrical specimens of Juncus-mixed tissue conditioner (dimensions: 10 mm in diameter and 2 and 6 mm in height for antimicrobial and mechanical tests, respectively) were prepared. The specimens placed on the bottom of the 24-well tissue culture plate were cultured with Candida albicans CAD1 for 2 and 4 days. The proliferation of the C. albicans in the wells was determined by measuring the optical density of fungal culture, and the surface of the specimens were also observed by scanning electron microscopy (SEM). To assess the mechanical properties of the specimens, the fluidity and hardness of Juncus-mixed tissue conditioner were measured using the methods certified according to ISO 10139-1. RESULTS: Juncus-mixed tissue conditioner significantly exhibited growth inhibitory effect in a Juncus concentration-dependent manner after both 2- and 4- day cultures. SEM observation showed that the amount of C. albicans on Juncus-mixed specimens drastically decreased, and biofilm formation was markedly inhibited. Moreover, both mechanical properties were found to be within the ranges regulated and specified by ISO. CONCLUSION: These findings demonstrated that the tissue conditioner including Juncus powder has a significant growth inhibitory effect against C. albicans, and it is suggested that the application of Juncus-mixed tissue conditioner may prevent denture stomatitis and oral candidiasis in denture wearers.

Changes in food bolus texture during mastication.

The purpose of this study was to survey the changes that occur in bolus texture from intake to swallowing during the mastication process for four types of food materials and to identify how texture is related to the number of chews. We recruited 15 young Japanese participants for this study. The subjects were asked to spit the food bolus just before swallowing when eating four different foods: cracker, boiled rice, hard gelatine gel, and soft gelatine gel. Three physical properties (hardness, adhesiveness, and cohesiveness) were measured in the bolus after being chewed for 25, 50, 75, 100, and 125% of the normal number of chews. Occlusal force and pressure as well as stimulated whole saliva volume were also measured. Extensive variation in the number of chews existed between subjects, but minimal intra-subject variation was observed. Hardness was observed to decrease, whereas cohesiveness and adhesiveness increased in a chew-dependent manner for the cracker, soft gelatine gel, and hard gelatine gel, but not boiled rice. Bolus texture appears to be largely related to the number of chews. Hardness also tended to be influenced by occlusion. The adhesiveness and hardness of the boiled rice were also greatly influenced by saliva volume and occlusal force, respectively. Hardness is an important rheological factor in food bolus texture and likely plays a significant role in determining the appropriate number of chews. Adhesiveness and cohesiveness appear to be secondary factors in this process. PRACTICAL APPLICATIONS: We propose a model of oral processing for application in determining the appropriate number of chews for an individual. Hardness appears to be an important rheological factor in food bolus texture, with adhesiveness and cohesiveness being secondary aspects. When food is hard or difficult to swallow, chewing behavior will likely be more influenced by the perception of bolus texture.

Reliability and validity of the patient disability-oriented diagnostic nomenclature system for prosthetic dentistry.

PURPOSE: The Japan Prosthodontic Society (JPS) has proposed a new diagnostic nomenclature system (DNS), based on pathogenesis and etiology, to facilitate and improve prosthodontic treatment. This system specifies patient disability and the causative factor (i.e. "B (disability) caused by A (causative factor)"). The purpose of this study was to examine the reliability and validity of this DNS. STUDY SELECTION: The JPS Clinical Guideline Committee assessed mock patient charts and formulated disease names using the new DNS. Fifty validators, comprising prosthodontic specialists and dental residents, made diagnoses using the same patient charts. Reliability was evaluated as the consistency of the disease names among the validators, and validity was evaluated using the concordance rate of the disease names with the reference disease names. RESULTS: Krippendorff's α was 0.378 among all validators, 0.370 among prosthodontic specialists, and 0.401 among dental hospital residents. Krippendorff's α for 10 validators (3 specialists and 7 residents) with higher concordance rates was 0.524. Two validators (1 specialist and 1 resident) with the highest concordance rates had a Krippendorff's α of 0.648. Common disease names had higher concordance rates, while uncommon disease names showed lower concordance rates. These rates did not show correlation with clinical experience of the validator or time taken to devise the disease name. CONCLUSIONS: High reliability was not found among all validators; however, validators with higher concordance rates showed better reliability. Furthermore, common disease names had higher concordance rates. These findings indicate that the new DNS for prosthodontic dentistry exhibits clinically acceptable reliability and validity.

Characterization of Swallowing Sound: Preliminary Investigation of Normal Subjects.

OBJECTIVE: The purpose of this study was to characterize the swallowing sound and identify the process of sound generation during swallowing in young healthy adults. METHODS: Thirty-three healthy volunteers were enrolled and allocated into three experimental groups. In experiment 1, a microphone was attached to one of eight cervical sites in 20 subjects, participants swallowed 5 ml water, and the sound waveform was recorded. In experiment 2, 10 subjects swallowed either 0, 5, 10, or 15 ml water during audio recording. In addition, participants consumed the 5 ml bolus in two different cervical postures. In experiment 3, the sound waveform and videofluoroscopy were simultaneously recorded while the three participants consumed 5 ml iopamidol solution. The duration and peak intensity ratio of the waveform were analyzed in all experimental groups. RESULTS: The acoustic analysis of the waveforms and videofluoroscopy suggested that the swallowing sound could be divided into three periods, each associated with a stage of the swallowing movement: the oral phase comprising posterior tongue and hyoid bone movement; the pharyngeal phase comprising larynx movement, hyoid bone elevation, epiglottis closure, and passage of the bolus through the esophagus orifice; and the repositioning phase comprising the return of the hyoid bone and larynx to their resting positions, and reopening of the epiglottis. CONCLUSION: Acoustic analysis of swallowing sounds and videofluoroscopy suggests that the swallowing sound could be divided into three periods associated with each process of the swallowing movement: the oral phase comprising the posterior movement of the tongue and hyoid bone; the pharyngeal phase comprising the laryngeal movement, hyoid bone elevation, epiglottis closure, and the bolus passage to the esophagus orifice; and the repositioning phase comprising the repositioning of the hyoid bone and larynx, and reopening of the epiglottis.

Study protocol for a multi-center, randomized controlled trial to develop Japanese denture adhesive guidelines for patients with complete dentures: the Denture Adhesive Guideline trial: study protocol for a randomized controlled trial.

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.