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Determinants of Tooth Movement in Oral Appliance Treatment of OSA.

NCT03341130 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2023-09-28

No results posted yet for this study

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

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • Université de Montréal

    collaborator OTHER

  • Laval University

    collaborator OTHER

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Benjamin T Pliska, DDS · University British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2024-07-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03341130 on ClinicalTrials.gov