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OpenTrials
Completed

NCT Number: NCT05553860

Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Speech positioning technique

Other

Speech positioning technique

Primary outcomes

  1. 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

  1. Overjet

    Time frame: 3 months

    Measurement to determine whether there is a significant difference in final treatment mandibular position between the positioning techniques.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Sep 23, 2022
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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