Trial record 5 of 12 for:    denture [CONDITION] OR denture [TREATMENT] | Open Studies

The Effect of Nocturnal Wear of Dentures on Sleep and Oral Health Related Quality of Life

This study is not yet open for participant recruitment.
Verified August 2013 by Université de Montréal
Sponsor:
Information provided by (Responsible Party):
Elham Emami, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01868295
First received: May 29, 2013
Last updated: August 26, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Sleep Apnea, Obstructive
Behavioral: Sleeping with denture

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 206
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)
Arms Assigned Interventions
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • be aged 65 years or older; have worn a complete set of removable dentures in the last year AND not have worn a denture during sleep in the last 12 months;
  • have an adequate understanding of written and spoken English or French;
  • be able to understand and respond to the questionnaires used in the study;
  • agree to follow the research study instructions;
  • agree to maximally adhere to the allocated study arm;
  • consume no alcohol and not work late at night on the day before polysomnography

Exclusion Criteria:

  • have any severe cardiologic, neurologic, psychological, or psychiatric condition, respiratory disease,acute airway infection or any other health condition that jeopardizes sleep;
  • have a score of 24 or less on the mini-mental state evaluation 125;
  • have a body mass index above 30 kg/m2;
  • regularly consume more than 2 alcoholic beverages per day for females and 3 for males;
  • are taking medication or any illicit drug that will affect sleep architecture or respiratory muscle activity (i.e., hypnotics, psychostimulants, anticonvulsant, or antipsychotics);
  • are on continuous positive airway pressure therapy or nocturnal supplemental oxygen;
  • have sleepiness deemed to be unsafe and requiring urgent treatment;
  • feel that the trial would be detrimental to their private life.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01868295

Contacts
Contact: Elham Emami, DDS, MSc,PhD 514-343-6111 ext 6053 elham.emami@umontreal.ca

Locations
Canada, Quebec
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         
Sponsors and Collaborators
Université de Montréal
  More Information

No publications provided

Responsible Party: Elham Emami, Associate professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01868295     History of Changes
Other Study ID Numbers: FMD-UdeM-EE-2013a
Study First Received: May 29, 2013
Last Updated: August 26, 2013
Health Authority: Canada: Institutional Review Board

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 23, 2014