The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life
Complete tooth loss and sleep problems are common conditions in elders. Tooth loss can influence sleep quality by changing the shape of the lower face and upper airway. Some studies suggest that sleeping without dentures can worsen sleep quality in toothless elders. However, sleeping without dentures is believed to favor oral health. This concerns clinicians as there are no practice guidelines on these issues.
To address this knowledge gap, over the past 5 years we have examined the quality of sleep of a group of edentulous elders. In addition, we conducted a pilot study to examine the link between night-time denture wear, and sleep. Our results indicate that edentulous elders who wore their dentures at night had high levels of daytime sleepiness. Furthermore, use of dentures at night increases the risk of apneic events in those elders who had mild sleep disturbance.
In line with our previous research, the aim of the proposed study is to produce reliable evidence that clinical practice guidelines could be based on. They will be used by dentists and doctors who treat millions of toothless elders in Canada and around the world.
We will enroll 206 toothless elders who will be randomly assigned to wear and not wear their dentures at night for periods of 15 days. Sleep studies will be conducted at the homes of participants. The participants will also be asked to respond to questions on sleep quality and oral health quality of life. Ultimately, the results of this study will help improve the health and quality of life of elders in Canada and around the world.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
|Official Title:||The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life: a Randomized Cross-Over Trial|
- Sleep quality [ Time Frame: 15 days ] [ Designated as safety issue: No ]Sleep quality is measured by the AHI. The AHI index will be measured by use of diagnostic portable polysomnography.
- Daytime sleepiness [ Time Frame: 15 days ] [ Designated as safety issue: No ]The Sleepiness Scale (ESS) will be used to assess perceived daytime sleepiness. Participants will be asked to rate their chance of dozing in eight different sedentary situations.
- Oral health related quality of life [ Time Frame: 15 days ] [ Designated as safety issue: No ]Oral health related quality of life will be measured by means of the oral health impact profile (OHIP-20). This instrument is a disease-specific measure of people's perceptions of their physical, psychological,and social impacts of oral health on their quality of life.
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Sleeping with denture
Sleeping with denture at night
Behavioral: Sleeping with denture
Sleeping with denture at night
No Intervention: Sleeping without denture
Sleeping without denture at night
BACKGROUND Aging substantially increases the risk of edentulism and sleep disturbance. These two chronic conditions have serious adverse consequences for the functioning and quality of life of elders and place a significant burden on the health care system. 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. While there is some evidence suggesting that not wearing dentures at night can worsen sleep quality and lead to severe sleep disturbance in edentate elders, there are also studies that have suggested the opposite. The current controversy does not permit clinicians to engage in evidence-based clinical decision-making.
To enable development of clinical practice guidelines, solid evidence is required. This proposed randomized trial represents the logical next step of the clinical investigations conducted by our multidisciplinary expert team of oral health and sleep researchers from the University of Montreal, McGill University, University of British Colombia, and Laval University. Our pilot data suggest that edentate elders who wear dentures at night experience more daytime sleepiness than those who do not. Furthermore, we found that the nocturnal use of dentures substantially increases the risk of apneic events in seniors affected by mild sleep disturbance.
OBJECTIVES The primary objective of this study is to test whether nocturnal denture wear affects sleep quality and daytime sleepiness of edentate elders. Our secondary objective is to test whether nocturnal denture wear affects the oral-health-related quality of life of edentate elders. The third objective is to identify moderators of effect of nocturnal denture wear so as to identify patient subgroups where the intervention may be more efficacious.
METHODS We will carry out a single-blind randomized cross-over clinical trial, into which 206 edentate elders will be enrolled. Study participants will be assigned to wear and not wear their denture in alternate orders for periods of 15 days. The primary outcome measure will be sleep quality (measured by the apnea-hypopnea index). The secondary outcome measures will be daytime sleepiness and oral health-related quality of life. Outcome assessments will be carried out with instrument- and patient-based sleep measurements, including portable polysomnography, the Epworth Sleepiness Scale and an oral health-related quality of life questionnaire. Explanatory variables will include socio-demographic, oropharyngeal morphology, oral and prosthesis characteristics, as well as perceived general health quality of life. These characteristics will be assessed by means of clinical examination, 3D imaging (Cone Beam Computed Tomography) of the cranio-facial structure, as well as validated questionnaires. Assessments will be done at baseline and at the end of each of the 15-day intervention periods. Linear mixed-effects regression models for repeated measures will be fitted to test the study hypotheses while accounting for chance confounding and multiple outcome testing. 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.
SIGNIFICANCE Our findings will have important clinical implications and will help to resolve the current uncertainty about the effects of nocturnal wearing of dentures in the edentate elderly population. This practice-relevant evidence could represent a preventive approach to improve sleep characteristics of the older population and, thereby, improve their well-being and quality of life. This evidence will be shared with the Canadian Dental Association, the Canadian and the American Academy of Dental Sleep Medicine and the Canadian Sleep Society to assist these agencies in producing practice guidelines for primary care providers, dentists, and sleep medicine specialists involved in the care of edentate elders.
|Contact: Elham Emami, DDS, MSc,PhD||514-343-6111 ext firstname.lastname@example.org|
|Université de Montréal||Not yet recruiting|
|Montreal, Quebec, Canada|
|Principal Investigator: Elham Emami, DDS.MSc,PhD|
|Sub-Investigator: Nelly Huynh, PhD|
|Sub-Investigator: Gilles Lavigne, DMD, MSc, PhD|