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Implant Supported Oral Appliance Treatment of OSA

NCT03362671 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2022-11-22

No results posted yet for this study

Summary

Mandibular advancing oral appliances (OAm) are an effective and increasingly common treatment modality for the management of obstructive sleep apnea (OSA) in adults.

The effectiveness of OAm therapy, however, is dependent on a high level of patient adherence, which may be negatively impacted by treatment side effects - the most significant of which are occlusal changes and tooth movement.

The proposed pilot study will evaluate the efficacy of a novel implant supported OAm in 10 OSA patients who have already been successfully treated with a traditional OAm.

The study will compare OSA specific outcomes with traditional OAm use against novel oral appliance use after one month. This study could potentially validate the novel design features of an effective treatment option for OSA that does not result in tooth movement, which is a significant side effect shared by all existing OAm devices.

Ultimately, this study could lead to increased treatment adherence and better OSA patient health outcomes in the future.

Conditions

Interventions

DEVICE

Implant Supported Mandibular Advancement Oral Appliance

This device is a novel oral appliance that attached to orthodontic mini implants in the jaw and is designed to keep the jaw in an advanced position, opening the upper airway during sleep.

DEVICE

Orthodontic Mini Implant

Small titanium devices that are fixed to the bone for the purpose of enhancing anchorage of other orthodontic devices.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Benjamin T Pliska, DDS · University British Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-01
Primary Completion
2019-06-11
Completion
2019-09-11

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03362671 on ClinicalTrials.gov