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Clinical Trials/NCT05553860
NCT05553860
Completed
Not Applicable

Two Cohort Prospective Single Blinded Patient Crossover Trial Comparing Anterior Protrusive and Sibilant Phoneme Mandibular Positioning Techniques for Dental Sleep Appliances

University of Alberta1 site in 1 country11 target enrollmentDecember 5, 2021

Overview

Phase
Not Applicable
Intervention
Speech positioning technique
Conditions
Sleep Apnea, Obstructive
Sponsor
University of Alberta
Enrollment
11
Locations
1
Primary Endpoint
Apnea-hypopnea index (AHI)
Status
Completed
Last Updated
last month

Overview

Brief Summary

This is a prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

Detailed Description

Obstructive sleep apnea is a medical condition where a person has great difficulty with breathing, or stops breathing all together, while asleep. This is a medical condition for which one of the current standard treatments is the use of a custom-made dental appliance to help hold the person's airway open while asleep so that the person does not suffocate while sleeping. Current methodology within dentistry is to position the mandible based on the person's maximum ability to position their mandible forward as the starting point and then slowly move the bottom jaw forward as necessary. Recent literature has shown that different mandibular positioning techniques may require less protrusion, less titrations, and potentially decreased side effects compared with the traditional protrusive techniques. One of the most promising techniques involves the use of speech to determine mandibular position. This technique would not require that a patient place their jaw outside of their normal functional range and could potentially decrease the face pain/jaw joint problems commonly associated with the use of oral sleep appliances for the treatment of obstructive sleep apnea. The use of speech as the determinant for where to position the mandible is important for muscular balance. Minimal research has been done in this area, with most studies being either retrospective or confounded by other variables. This will be the first prospective study that directly compares the use of speech vs an anterior protrusive technique for mandibular positioning.

Registry
clinicaltrials.gov
Start Date
December 5, 2021
End Date
December 3, 2025
Last Updated
last month
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patient diagnosed with obstructive sleep apnea, and
  • Prescription/order for a dental sleep appliance
  • 18 years or older
  • Treatment planned in accordance with AADSM treatment guidelines

Exclusion Criteria

  • There are no separate exclusion criteria

Arms & Interventions

Anterior Protrusive

use of anterior protrusive positioning technique

Intervention: Speech positioning technique

Speech Position

use of speech positioning technique

Intervention: Speech positioning technique

Outcomes

Primary Outcomes

Apnea-hypopnea index (AHI)

Time Frame: 3 months

Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea

Secondary Outcomes

  • Overjet(3 months)

Study Sites (1)

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