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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.

ABSTRACT: 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.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.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.ClinicalTrials.gov NCT01712802 . Registered on 17 October 2012.

SUBMITTER: Kimoto S

PROVIDER: S-EPMC5070081 | biostudies-literature | 2016 Oct

REPOSITORIES: biostudies-literature

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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.

Kimoto Suguru S Kawai Yasuhiko Y Gunji Atsuko A Kondo Hisatomo H Nomura Taro T Murakami Tomohiko T Tsuboi Akito A Hong Guang G Minakuchi Shunsuke S Sato Yusuke Y Ohwada Gaku G Suzuki Tetsuya T Kimoto Katsuhiko K Hoshi Noriyuki N Saita Makiko M Yoneyama Yoshikazu Y Sato Yohei Y Morokuma Masakazu M Okazaki Joji J Maeda Takeshi T Nakai Kenichiro K Ichikawa Tetsuo T Nagao Kan K Fujimoto Keiko K Murata Hiroshi H Kurogi Tadafumi T Yoshida Kazuhiro K Nishimura Masahiro M Nishi Yasuhiro Y Murakami Mamoru M Hosoi Toshio T Hamada Taizo T

Trials 20161018 1

<h4>Background</h4>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 ...[more]

PMID: 27756441

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Project description:BackgroundDenture adhesives can be useful in improving patients' satisfaction with complete dentures. However, comparison clinical trials are lacking. The purpose of this randomized clinical trial was to assess the satisfaction of edentulous patients and their oral health impact profile when provided with 3 types of denture adhesives.MethodsSixty-four completely edentulous patients seeking complete dentures for their first time were randomly divided into 3 groups. Each group received a set of complete dentures, which were adjusted at review appointments until participants reported no complaints. After 1 month of using the dentures, participants rated their overall satisfaction and their satisfaction regarding comfort, retention, stability, and efficiency of mastication and speech on a 100-mm visual analog scale (VAS). Participants also filled out the oral health impact profile for edentulous patients (OHIP-EDENT) questionnaire. Each group was then given 1 type of denture adhesive to use. Group C received Corega Ultra denture fixative cream (GlaxoSmithKline), Group O received Olivafix (Bonyf), and Group S received Sea. Bond adhesive strips (Sea.Bond). Mann-Whitney U test was used to analyze the differences in VAS scores before and after using the adhesive within each group and Wilcoxon-signed rank test was used to compare OHIP scores and total OHIP values before and after using the adhesive within each group (p = 0.05). Furthermore, Kruskal Wallis test was used to compare the differences before and after using the adhesives in VAS and OHIP values between the 3 groups.ResultsSignificantly higher VAS values were detected in all groups and significantly lower values for many OHIP items in addition to total OHIP values were detected in all groups after using the adhesives (P < 0.05), except for the ease of cleaning for Group O and Group S (P > 0.05). No significant differences were found in VAS and OHIP values between the 3 groups (P > 0.05), except for the ease of cleaning which was significantly different between Group C and Group S (p = 0.005).ConclusionsUsing denture adhesives for completely edentulous patients resulted in higher patient satisfaction as indicated by higher VAS scores as well as improved quality of life as indicated by lower OHIP-EDENT scores after using the adhesives. These improvements were not dependent on the type of adhesive, except for ease of cleaning as adhesive strips were easier to clean than paste type adhesives.Trial registrationThis trial was registered at ClinicalTrials.gov (ID: NCT05496283) on 11/08/2022.

Project description:Edentulism and sleep disturbance are chronic conditions that are common in older people and have serious adverse consequences for their functioning and quality of life. Edentulism can disturb sleep through the alteration of the craniofacial structure and surrounding soft tissue. However, the effect of prosthetic rehabilitation of edentulism on sleep quality is still not well understood. The objectives of this study are to test whether nocturnal denture wear affects sleep quality, daytime sleepiness, and the oral health related quality of life of edentate older people with moderate to severe sleep apnea, and to identify modifiers of effect of nocturnal denture wear.We will carry out a single-blind randomized cross-over trial. Seventy edentate older people with moderate to severe obstructive sleep apnea will be enrolled. The study participants will be assigned to wear and not wear their dentures on alternate periods of 30 days. The outcome measures will be sleep quality (assessed by portable polysomnography), daytime sleepiness (assessed by the Epworth Sleepiness Scale), and oral health related quality of life (assessed by validated questionnaire). A number of characteristics (sociodemographic, oropharyngeal morphology, oral and prosthesis characteristics, and perceived general health quality of life) will be assessed by means of clinical examination, 3D imaging of the craniofacial structure, and validated questionnaires at baseline. Linear mixed effects regression models for repeated measures will be fitted to test the study hypotheses. The main analyses will be based on the intention-to-treat principle. To assess the robustness of the findings to potential incomplete adherence, sensitivity analyses will be conducted while applying the per-protocol principle.This practice-relevant evidence could represent a preventive approach to improve sleep characteristics of the older population and improve their well-being and quality of life.ClinicalTrials.gov NCT01868295.

Project description:PURPOSE:To study the effects of denture adhesive upon denture micromovements in three dimensions during the chewing of hard, sticky, and tough food items observed using a novel method involving an electromagnetic articulograph (EMA) speech research system. MATERIALS AND METHODS:Ten volunteers (mean age 60.9 ± 10.4 years) with fair- or poor-fitting complete maxillary dentures were enrolled. Chewing experiments were conducted using two treatments (adhesive or no-adhesive control) and three foods: carrots (hard), raisins (sticky), and processed meat stick (tough). Denture micromovement was measured through a novel application of a Northern Digital Wave EMA System. Three-dimensional denture position was captured during mastication using three sensors embedded into a replica denture for each subject. Following individual characterization of a "home" reference position, the Euclidean Distances from Home (DfH) were calculated for each recorded sample of the chewing experiments. The DfH at each sample represented the denture movement for that 1/100th of a second of the activity. The DfH data were then summarized as the mean DfH, the maximum DfH, and total distance traveled by the denture. Several thresholds were also analyzed, including the percent of time that the DfH ≥1.5 mm, ≥2.0 mm, and ≥2.5 mm. RESULTS:With adhesive treatment, the mean DfH of dentures during chewing was reduced by 26.8% for carrot, 30.3% for raisin, and 31.0% for meat stick, when compared with no-adhesive treatment (p < 0.001 for all comparisons). Similar results were also seen for the maximum DfH and total distance travelled endpoints across foods. For the threshold endpoints, adhesive treatment was associated with a statistically significant reduction in denture micromovements at all three thresholds across foods. At the threshold of DfH ≥ 1.5 mm, adhesive treatment was associated with a reduction in micromovement by 61.6%, 56.2%, and 70.0% with carrot, raisin, and meat stick, respectively (p ≤ 0.004 for all comparisons). CONCLUSIONS:Observations of denture movement using the Wave EMA System were able to differentiate systematically between adhesive treatment and no-adhesive treatment for denture micromovements during different chewing challenges. Use of adhesive was associated with statistically significant reductions in denture micromovements for hard, sticky, and tough foods as measured with both distance and threshold endpoints.

Project description:BACKGROUND: The number of people with diabetes is increasing worldwide, especially in developing South Asian countries. Therefore, preventing diabetes at the early stages has become an important issue. Recent clinical trials, systematic reviews, and meta-analysis have shown that zinc has beneficial effects on glycemic and metabolic control in those with diabetes. The present study is designed to evaluate the effects of zinc supplementation on glycemic control and other metabolic parameters in those with pre-diabetes. METHODS/DESIGN: The study will be conducted as a randomized, double-blind, placebo-controlled clinical trial for a period of 12 months at the Faculty of Medicine, University of Colombo, Sri Lanka. The study has been approved by the Ethics Review Committee of Faculty of Medicine, University of Colombo (EC/11/189). A total of 200 adults (age 18-60 years) with pre-diabetes will be recruited for the study. They will be stratified according to age, gender, and body mass index and randomly assigned into the test and placebo groups on a 1:1 ratio. The zinc capsules, each weighing 456 mg, will contain the following ingredients:zinc sulfate monohydrate 55.096 mg (elemental zinc 20 mg), lactose monohydrate 399.504 mg, and stearic acid 1.400 mg. The placebo capsule with the same weight will be comprised of lactose monohydrate 454.600 mg and stearic acid 1.400 mg. The subjects will receive either zinc 20 mg capsules or placebo daily for a period of 12 months. The study drugs will be double blinded to both investigators and subjects. The visits and the evaluations will be done as follows: screening (visit 0), 1 month (visit 1), 3 month (visit 2), 6 month (visit 3), and 12 month (visit 4). The following primary outcome measures will be evaluated:fasting plasma glucose (FPG), post oral glucose tolerance test (OGTT), serum insulin, HbA1c, total/low-density lipoprotein (LDL)/high-density lipoprotein (HDL) cholesterol, triglycerides, serum zinc, and appetite using a visual analog scale. Secondary outcome measures include: blood pressure, anthropometry, and dietary assessment using a validated food frequency questionnaire. Data will be analyzed using SPSS v16. DISCUSSION: The present protocol will aim to establish the beneficial effects of zinc supplementation on disease progression in those with pre-diabetes and also establish its effectiveness in the prevention of diabetes mellitus. TRIAL REGISTRATION: Sri Lanka Clinical Trial Registry: SLCTR/2012/010.

Project description:Bone preservation is an essential issue in the context of last teeth extraction and complete edentulism. The intended treatment, whether a complete denture or an implant placement, is facilitated with a voluminous residual ridge. Bone resorption after multiple extractions has not been as well studied as the bone resorption that occurs after the extraction of a single tooth. Recent advances in bone substitute materials have revived this issue. The purpose of this study is to evaluate the interest in using bone substitute material to fill the socket after last teeth extraction in a maxillary immediate complete denture procedure compared with the conventional protocol without socket filling.A randomized, controlled, clinical trial was designed. The 34 participants eligible for maxillary immediate complete denture were divided into two groups. Complete dentures were prepared despite persistence of the last anterior teeth. The control group received a conventional treatment including denture placement immediately after extractions. In the experimental group, in addition to the immediate denture placement, a xenograft bone-substitute material (Bio-Oss Collagen®) was placed in the fresh sockets. The primary outcome of the study is to compare mean bone ridge height loss 1 year after maxillary immediate complete denture placement, with or without bone-substitute material, in incisor and canine sockets. The secondary outcomes are to compare the average bone ridge height and width loss for each extraction site. An original quantitative evaluation method using cone beam computed tomography was designed for reproducible measurements, with a radio-opaque denture duplicate. Two independent operators perform the radiologic measurements.The immediate complete denture technique limits bone resorption in multiple extraction situations and thus allows better denture retention and better options for implant placement. To compare the benefit of using any bone socket-filling material, we proposed a quantitative evaluation protocol of resorption in the specific case of the last anterior maxillary teeth extraction with immediate denture placement.ClinicalTrials.gov, NCT02120053 . Registered on 18 April 2014.

Dataset Information

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.

Publications

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.

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