Determinants of Tooth Movement in Oral Appliance Treatment of OSA.

NCT03341130 | Unknown FDA Device

• 1 other identifier: F17-00320
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in Overjet

  The change in the extent of horizontal (anterior-posterior) overlap of the maxillary central incisors over the mandibular central incisors, measured from digital dental model analysis.

  Data collected at 0, 18 and 36 months after appliance insertion.

Secondary Outcomes (9)

• Treatment Adherence

  Data collected every 6 months after treatment commencement, up to 36 months.

• Quality of Life using Functional Outcomes of Sleep Questionnaire (FOSQ-10)

  Data collected at 0, 1, 2, 18 and 36 months after appliance insertion.

• Daytime Sleepiness

  Data collected at 0, 1, 2, 18 and 36 months after appliance insertion.

• Change in Overbite

  Data collected at 0, 18 and 36 months after appliance insertion.

• Dental Crowding

  Data collected at 0, 18 and 36 months after appliance insertion.

Study Arms (3)

Treatment Group

EXPERIMENTAL

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.

Device: Mandibular Repositioning Splint; Device: Mandibular Advancement Oral Appliance

Positive Control Group

EXPERIMENTAL

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.

Device: Mandibular Advancement Oral Appliance

Negative Control Group

NO INTERVENTION

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 DEVICE

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

Also known as: Morning Repositioner, Morning Aligner

Treatment Group

Mandibular Advancement Oral Appliance DEVICE

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

Also known as: OAM, MAS

Positive Control Group; Treatment Group

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of British Columbia: lead
• Université de Montréal: collaborator
• Laval University: collaborator

Study Sites (1)

University of British Columbia

Vancouver, British Columbia, V6T 1Z3, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Benjamin T Pliska, DDS

  University British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Benjamin T Pliska, DDS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Analysis of primary outcomes will be performed by an examiner blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 14, 2017
• Study Start: August 22, 2018
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

CA (1)