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Determinants of Tooth Movement in Oral Appliance Treatment of OSA.

Obstructive Sleep Apnea

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.

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Participation Requirements

  • Sex:

    ALL

  • Eligible Ages:

    25 to 65

Participation 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* Pregnancy (if a participant becomes pregnant during the trial, the participant will be withdrawn from the study).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)

Study Location

University of British Columbia
University of British Columbia
Vancouver, British Columbia
Canada

Contact Study Team

Primary Contact

Benjamin T Pliska, DDS

[email protected]
604-822-7237
Backup Contact

Eleanor F Cawthorne, BSc

[email protected]
604-827-0690
Study Sponsored By
University of British Columbia
Participants Required
More Information
Study ID: NCT03341130