Effects of repositioning splints on tooth movement in sleep apnea treatment

Determinants of Occlusal Changes in Oral Appliance Treatment of OSA - A Randomized Controlled Trial

This study is testing if using special splints along with a common mouthpiece can help people with sleep apnea have better tooth movement and oral health.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 105 (estimated)
• Ages: 25 Years to 65 Years
• Sex: All
• Sponsor: University of British Columbia (Academic / other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT03341130 on ClinicalTrials.gov

What this trial studies

This study investigates the impact of using mandibular repositioning splints alongside mandibular advancement oral appliances (OAM) for treating obstructive sleep apnea (OSA). It aims to compare the bite changes in patients using OAM alone versus those using both OAM and repositioning splints. The study will also assess other factors such as oral health, the degree of mandibular advancement, and treatment adherence to understand their influence on occlusal changes. Conducted at three clinical centers, this single-blinded randomized controlled trial will involve 90 treatment-naive OSA patients aged 25 to 65.

Who should consider this trial

Good fit: Ideal candidates are treatment-naive adults aged 25 to 65 with a BMI of 35 or less and a documented diagnosis of OSA.

Not a fit: Patients with extensive periodontal disease, significant tooth mobility, or those unable to use OAM due to anatomical limitations may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved long-term adherence to OAM treatment by minimizing bite changes and enhancing patient quality of life.

How similar studies have performed: While the use of repositioning splints has been advocated in practice, this specific approach has not been previously studied in a prospective clinical trial.

Eligibility criteria

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)

Where this trial is running

Vancouver, British Columbia

• University of British Columbia — Vancouver, British Columbia, Canada (Recruiting)

Study contacts

• Principal investigator: Benjamin T Pliska, DDS — University British Columbia
• Study coordinator: Benjamin T Pliska, DDS

Conditions Obstructive Sleep Apnea; OSA; Mandibular Advancement Splint; Oral Appliance; Treatment; Repositioning Splint