Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances
Primary Purpose
Sleep Apnea, Obstructive, Occlusal Splints
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Speech positioning technique
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
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
Sites / Locations
- University of AlbertaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Anterior Protrusive
Speech Position
Arm Description
use of anterior protrusive positioning technique
use of speech positioning technique
Outcomes
Primary Outcome Measures
Apnea-hypopnea index (AHI)
Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea
Secondary Outcome Measures
Overjet
Measurement to determine whether there is a significant difference in final treatment mandibular position between the positioning techniques.
Full Information
NCT ID
NCT05553860
First Posted
September 21, 2022
Last Updated
October 20, 2023
Sponsor
University of Alberta
1. Study Identification
Unique Protocol Identification Number
NCT05553860
Brief Title
Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances
Official Title
Two Cohort Prospective Single Blinded Patient Crossover Trial Comparing Anterior Protrusive and Sibilant Phoneme Mandibular Positioning Techniques for Dental Sleep Appliances
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Occlusal Splints
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anterior Protrusive
Arm Type
Active Comparator
Arm Description
use of anterior protrusive positioning technique
Arm Title
Speech Position
Arm Type
Experimental
Arm Description
use of speech positioning technique
Intervention Type
Other
Intervention Name(s)
Speech positioning technique
Intervention Description
Speech positioning technique
Primary Outcome Measure Information:
Title
Apnea-hypopnea index (AHI)
Description
Measurement to determine whether both mandibular positioning techniques provide similar management of obstructive sleep apnea
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Overjet
Description
Measurement to determine whether there is a significant difference in final treatment mandibular position between the positioning techniques.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enoch Ng, DDS
Phone
780-407-5550
Email
enoch@ualberta.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Enoch Ng, DDS
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enich Ng, DDS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances
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