title: 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: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01868295.
authors.affiliation: Faculty of Dentistry, Université de Montréal, 2900 Edouard-Montpetit, Montreal, QC H3T 1J4, Canada. elham.emami@umontreal.ca.
authors.forename: Elham
authors.initials: E
authors.lastname: Emami
authors.forename: Phan The Huy
authors.initials: PT
authors.lastname: Nguyen
authors.forename: Fernanda R
authors.initials: FR
authors.lastname: Almeida
authors.forename: Jocelyne S
authors.initials: JS
authors.lastname: Feine
authors.forename: Igor
authors.initials: I
authors.lastname: Karp
authors.forename: Gilles
authors.initials: G
authors.lastname: Lavigne
authors.forename: Nelly
authors.initials: N
authors.lastname: Huynh
mesh_terms: D000368:Aged; D002985:Clinical Protocols; D018592:Cross-Over Studies; D003824:Denture, Complete / Q000009:adverse effects; D005260:Female; D006801:Humans; D007575:Jaw, Edentulous / Q000150:complications / Q000523:psychology / Q000534:rehabilitation*; D008297:Male; D009909:Oral Health; D011788:Quality of Life; D011792:Quebec; D012107:Research Design; D012720:Severity of Illness Index; D016037:Single-Blind Method; D012890:Sleep; D020181:Sleep Apnea, Obstructive / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control*; D011795:Surveys and Questionnaires; D013997:Time Factors