Determinants of Tooth Movement in Oral Appliance Treatment of OSA. (TACO)
Obstructive Sleep Apnea
About this trial
This is an interventional supportive care trial for Obstructive Sleep Apnea focused on measuring OSA, Mandibular Advancement Splint, Oral Appliance, Treatment, Repositioning Splint
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- Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).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)
Sites / Locations
- University of British ColumbiaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
No Intervention
Treatment Group
Positive Control Group
Negative Control 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.
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.
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.