Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05553860
• Other study ID #: Pro00097563
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2021
• Est. completion date: December 2024

Study information

• Verified date: October 2023
• Source: University of Alberta
• Contact: Enoch Ng, DDS
• Phone: 780-407-5550
• Email: enoch[@]ualberta.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sleep Apnea, Obstructive

Intervention

Other:
• Speech positioning technique
Speech positioning technique

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Alberta

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea-hypopnea index (AHI)	Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea	3 months
Secondary	Overjet	Measurement to determine whether there is a significant difference in final treatment mandibular position between the positioning techniques.	3 months