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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 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: July 10, 2014
Last verified: July 2014
  Purpose

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 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: 30 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: 30 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: 30 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.


Other Outcome Measures:
  • Explanatory variables [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
    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).


Estimated Enrollment: 70
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

  Show Detailed Description

  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 AHI ≥ 15 at screening
  • 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 sequence of interventions;
  • consume no alcohol and not work late at night on the day before polysomnography.

Exclusion Criteria:

  • have an AHI < 15;
  • 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;
  • 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 regular continuous positive airway pressure therapy or nocturnal supplemental oxygen;
  • have sleepiness deemed to be unsafe and requiring urgent treatment;
  • feel that the trial would negatively influence their private life.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Montreal, Quebec, Canada
Contact: Elham Emami, PhD    5143436111 ext 6053    elham.emami@umontreal.ca   
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 by Université de Montréal

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: July 10, 2014
Health Authority: Canada: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 23, 2014