The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial
نویسندگان
چکیده
BACKGROUND 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. METHODS/DESIGN 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. DISCUSSION 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. TRIAL REGISTRATION ClinicalTrials.gov NCT01868295.
منابع مشابه
The nocturnal use of complete dentures and sleep stability in edentulous elders.
OBJECTIVE To evaluate the stability of sleep quality and the impact of nocturnal use of complete dentures on sleep quality in an elderly edentulous population over a one-year period. MATERIALS AND METHODS Written informed consent was obtained from 172 edentulous elders who agreed to enrol in a longitudinal cohort study. A total of 153 participants completed the follow-up after one year. Perce...
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عنوان ژورنال:
دوره 15 شماره
صفحات -
تاریخ انتشار 2014