Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances

Not Applicable

Recruiting

• Conditions: Sleep Apnea, Obstructive; Occlusal Splints
• Interventions: Other: Speech positioning technique

• Registration Number: NCT05553860
• Lead Sponsor: University of Alberta

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.

Study Timeline

• Study Start: 2021-12-05
• Study First Submitted: 2022-09-21
• Study First Submitted QC: 2022-09-21
• Study First Posted: 2022-09-23
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Anterior Protrusive	Speech positioning technique	use of anterior protrusive positioning technique
Speech Position	Speech positioning technique	use of speech positioning technique

Primary Outcome Measures

Name	Time	Method
Apnea-hypopnea index (AHI)	3 months	Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea

Secondary Outcome Measures

Name	Time	Method
Overjet	3 months	Measurement to determine whether there is a significant difference in final treatment mandibular position between the positioning techniques.

Trial Locations

Locations (1)

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada