The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life
|ClinicalTrials.gov Identifier: NCT01868295|
Recruitment Status : Enrolling by invitation
First Posted : June 4, 2013
Last Update Posted : May 4, 2017
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. While some studies suggest that sleeping without dentures can worsen sleep quality in toothless elders, others suggest the opposite. Consequently, there are currently no evidence-based practice guidelines regarding whether dentures should be used at night, and dentists and doctors do not know how to properly advise their patients on these issues. To address this knowledge gap, over the past 5 years we have carried out research examining 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 seemed to increase the risk of apneic events in those elders who had mild sleep disturbance. While intriguing, these results require confirmation in larger samples. 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 and which could be used by dentists and doctors who treat toothless elders.
We will enroll 70 toothless elders who will be randomly assigned to wear and not wear their dentures at night for two periods of 30 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-related quality of life. Ultimately, the results of this study will help improve the health and quality of life of millions of elders in Canada and around the world.
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea, Obstructive||Behavioral: Sleeping with denture||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||September 2018|
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
- Sleep quality [ Time Frame: 30 days ]Sleep quality is measured by the AHI. The AHI index will be measured by use of diagnostic portable polysomnography.
- Daytime sleepiness [ Time Frame: 30 days ]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: 30 days ]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.
- Explanatory variables [ Time Frame: Baseline ]These include socio-demographic, medical, and anthropometric (weight, height) variables, oropharyngeal morphology (measured by a 3-dimensional imaging system, CBCT, NewTom 5G CBCT, QR S.r.l.-Verona, Italy), edentulism-associated variables, as well as perceived general health. Perceived general health will be assessed by the use of the Short Form-36 (SF-36).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868295
|Université de Montréal|
|Montreal, Quebec, Canada|