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The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial.

ABSTRACT: 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.

SUBMITTER: Emami E

PROVIDER: S-EPMC4177759 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

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The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial.

Emami Elham E Nguyen Phan The Huy PT Almeida Fernanda R FR Feine Jocelyne S JS Karp Igor I Lavigne Gilles G Huynh Nelly N

Trials 20140913

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

PMID: 25218696

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Project description: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.

Project description:BackgroundHealth-related quality of life (HRQOL) is an important outcome measure in patients with end-stage renal disease. HRQOL is assumed to improve with kidney transplantation and also with nocturnal hemodialysis compared to conventional hemodialysis. However, there is no evidence regarding HRQOL to support the optimal treatment choice for patients on nocturnal hemodialysis who hesitate opting for transplantation. We therefore compared HRQOL between patients who were treated with kidney transplantation or nocturnal hemodialysis for one year.MethodsWe assessed HQROL using the Kidney Disease Quality of Life-Short Form questionnaire in a cross-sectional sample of patients who were treated with kidney transplantation (n = 41) or nocturnal hemodialysis (n = 31) for one year. All patients on nocturnal hemodialysis were transplantation candidates. Using linear regression, we compared HRQOL between kidney transplantation and nocturnal hemodialysis, and adjusted for age, sex, dialysis duration, cardiovascular disease, and presence of residual urine production.ResultsAt one year follow-up, mean age of the study population was 54 ±13 years, and median dialysis duration was 3.2 (IQR 2.1-5.0) years. Kidney transplantation was associated with significantly higher HRQOL on the domain "effects" compared to nocturnal hemodialysis (adjusted difference 12.0 points, 95% CI 3.9; 20.1). There were potentially clinically relevant differences between kidney transplantation and nocturnal hemodialysis on the domains "burden" (adjusted difference 11.1 points, 95% CI -2.6; 24.8), "social support" (adjusted difference 6.2, 95% CI -6.6; 19.1), and the physical composite score (adjusted difference 3.0, 95% CI -2.0; 8.1), but these were not significant.ConclusionsAfter kidney transplantation, HRQOL is especially higher on the domain "effects of kidney disease" compared to nocturnal hemodialysis. This can be useful when counseling patients on nocturnal hemodialysis who may opt for transplantation.

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The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial.

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The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial.

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