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

NCT01868295 | Completed DMC

• 1 other identifier: FMD-UdeM-EE-2013a
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Sleep quality

  Sleep quality is measured by the AHI. The AHI index will be measured by use of diagnostic portable polysomnography.

  30 days

Secondary Outcomes (2)

• Daytime sleepiness

  30 days

• Oral health related quality of life

  30 days

Other Outcomes (1)

• Explanatory variables

  Baseline

Study Arms (2)

Sleeping with denture

EXPERIMENTAL

Sleeping with denture at night

Behavioral: Sleeping with denture

Sleeping without denture

NO INTERVENTION

Sleeping without denture at night

Interventions

Sleeping with denture BEHAVIORAL

Sleeping with denture at night

Sleeping with denture

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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 ≥ 10 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.

You may not qualify if:

• have an AHI \< 10;
• 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.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Université de Montréal

Montreal, Quebec, Canada

Location

Related Publications (4)

• Chen H, Emami E, Kauffmann C, Rompre P, Almeida F, Schmittbuhl M, van der Stelt P, Ge S, Lavigne G, Huynh N. Airway Phenotypes and Nocturnal Wearing of Dentures in Elders with Sleep Apnea. J Dent Res. 2023 Mar;102(3):263-269. doi: 10.1177/00220345221133278. Epub 2022 Nov 4.

  PMID: 36333889 DERIVED

• Chen H, Elham E, Li Y, Ge S, Schmittbuhl M, Lavigne G, van der Stelt PF, Huynh N. Comparison of anatomic and aerodynamic characteristics of the upper airway among edentulous mild, moderate, and severe obstructive sleep apnea in older adults. J Clin Sleep Med. 2022 Mar 1;18(3):759-768. doi: 10.5664/jcsm.9716.

  PMID: 34636319 DERIVED

• Emami E, Lavigne G, Feine JS, Karp I, Rompre PH, Almeida FR, Huynh NT. Effects of nocturnal wearing of dentures on the quality of sleep and oral-health-related quality in edentate elders with untreated sleep apnea: a randomized cross-over trial. Sleep. 2021 Oct 11;44(10):zsab101. doi: 10.1093/sleep/zsab101.

  PMID: 33955479 DERIVED

• Emami E, Nguyen PT, Almeida FR, Feine JS, Karp I, Lavigne G, Huynh N. The effect of nocturnal wear of complete dentures on sleep and oral health related quality of life: study protocol for a randomized controlled trial. Trials. 2014 Sep 13;15:358. doi: 10.1186/1745-6215-15-358.

  PMID: 25218696 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Sleep; Dentures

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Dental Prosthesis; Prosthodontics; Dentistry; Prostheses and Implants; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: June 4, 2013
• Study Start: April 1, 2014
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2019
• Last Updated: September 18, 2019

Record last verified: 2019-09

Locations

CA (1)