Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT03341130

Conditions

Obstructive Sleep Apnea

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Interventions

Mandibular Repositioning Splint

Mandibular Advancement Oral Appliance

Study Details

Brief summary:

Obstructive sleep apnea (OSA) is a sleep related breathing disorder, affecting approximately 10% of adults. Mandibular advancement oral appliances (OAM) are an effective treatment for OSA, however, long term use has shown to lead to changes in teeth positioning and jaw alignment (bite changes), which has resulted in some patients stopping treatment.

It is becoming common clinical practice for doctors to prescribe the use of repositioning splints to help reduce the bite changes associated with using OAM. However, this has not been studied in a clinical trial.

This study will compare the bite changes between patients using OAM alone against patients using a morning repositioning splint in addition to OAM. Other variables, such as oral health, the size of mandibular advancement, and treatment adherence will also be measured to determine if they have an effect on the bite changes associated with OAM use.

By understanding the key the factors that influence the bite changes associated with OAM use and potentially validating a technique to reduce these changes, this study will improve the clinical practice of Dental Sleep Medicine, leading to improved health outcomes for OSA patients.

Conditions

Obstructive Sleep Apnea

Study ID

NCT03341130

Start date

Aug 22, 2018

Status verified date

Sep, 2023

Completion date

Dec, 2024

Anticipated

Primary completion date

Jul, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Treatment naive (have never used an oral appliance as treatment for OSA);
  • Age 25 - 65 years old, who are able to freely provide informed consent;
  • Body Mass Index (BMI) ≤ 35;
  • 8 or more teeth per arch to support treatment with OAM;
  • Apnea-Hypopnea Index (AHI) within the range 5≤AHI≤50 documented with polysomnography in the last 2 years \*\*\*OR\*\*\*
  • Respiratory Disturbance Index (RDI) within the range 20 ≤ RDI ≤ 50 documented with level III portable sleep test \*\*\*OR\*\*\*
  • Oxygen Desaturation Index (ODI) ≥ 10

Exclusion Criteria:

  • Extensive periodontal disease with significant tooth mobility;
  • Inability to protrude jaw;
  • Insufficient vertical opening to accommodate treatment with OAM;
  • Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).
  • Uncontrolled congestive heart failure (defined as a prior clinical diagnosis, an ejection cut-off of 40% or clinical sign in the opinion of a primary care physician or cardiologist) that makes it unsafe in the opinion of the investigators for the subject to participate in the trial;
  • Coronary artery disease unless stable for at least 6 months and considered by the investigators to have a stable disease;
  • Any history of angina, myocardial infarction or stroke;
  • Any history of major depressive disorder along with current moderate-severe disease;
  • Active cancer management (unless in remission for more than 1 year);
  • Known renal failure (with need for dialysis)

Study Design

Enrollment

105 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Treatment Group

The treatment group will will be treated a mandibular advancement oral appliance following standard practices. The treatment group will also receive a mandibular repositioning splint to wear in the mornings for a minimum of 1 hour following removal of their mandibular advancement oral appliance, in an effort to reduce the side effects resulting from use of the mandibular advancement oral appliance.

experimental: Positive Control Group

The positive control group will will be treated a mandibular advancement oral appliance following standard practices. The positive control group will not receive any additional oral appliances. Side effects resulting from use of the mandibular advancement oral appliance will be managed using standard practices, including jaw stretching exercises as needed for comfort.

no intervention: Negative Control Group

The negative control group is comprised of 15 healthy individuals recruited specifically from faculty members at the UBC Faculty of Dentistry. This group will undergo the same clinical data collection as the treatment group and the negative control group but will not receive any treatment.

Interventions

Mandibular Repositioning Splint

The Morning Repositioner is a hands-free bite deprogrammer designed to help return the patient's jaw back to its pre-treatment centric position.

Mandibular Advancement Oral Appliance

Mandibular Advancement Oral Appliances are dental splints used to keep the jaw in an advanced position, opening the upper airway during sleep.

Primary outcome measure

  • Change in Overjet [ Time Frame: Data collected at 0, 18 and 36 months after appliance insertion. ]

Central Contacts and Locations

Central contacts

Benjamin T Pliska, DDS

604-822-7237pliska@dentistry.ubc.ca

Locations

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6T 1Z3

Contacts

Benjamin T Pliska, DDS

604-822-7237pliska@dentistry.ubc.ca

Eleanor F Cawthorne, BSc

604-827-0690ecawthorne@dentistry.ubc.ca

Principal Investigator:

Benjamin T Pliska, DDS

More Information

Sponsor

University of British Columbia

Last update posted

Sep 28, 2023

Last verified

Sep, 2023

Keywords

  • OSA
  • Mandibular Advancement Splint
  • Oral Appliance
  • Treatment
  • Repositioning Splint

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2023-09-28.