Comparing Two Mandibular Positioning Techniques for Dental Sleep Appliances

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-05

Study Completion Date

2028-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Upper Airway's Pressure Drop Analyses After Mandibular Advancement and Maxillary Expansion

NCT04190953

Apnea Airway Obstruction, Nasal Mandible Small +1 more

RECRUITING NA

Titration of Oral Appliance Therapy: a Prospective, Randomized Cross-over Trial.

NCT03716648

Obstructive Sleep Apnea

COMPLETED NA

The Effects of Oral Appliance Therapy on Masseter Muscle Activity in Obstructive Sleep Apnea

NCT02011425

Obstructive Sleep Apnea

COMPLETED NA

Determinants of Tooth Movement in Oral Appliance Treatment of OSA.

NCT03341130

Obstructive Sleep Apnea

UNKNOWN NA

The Effect of Ultrasound on Orthodontic Tooth Movement

NCT01828164

Malocclusion

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sleep Apnea, Obstructive Occlusal Splints

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Anterior Protrusive

use of anterior protrusive positioning technique

Group Type ACTIVE_COMPARATOR

Speech positioning technique

Intervention Type OTHER

Speech positioning technique

Speech Position

use of speech positioning technique

Group Type EXPERIMENTAL

Speech positioning technique

Intervention Type OTHER

Speech positioning technique

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Speech positioning technique

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes