Evaluation of the Dental Movements Caused by Oral Appliance in Sleep Apnea Syndrome (DPOAM)

September 5, 2025 updated by: Centre Hospitalier de Valence

Evaluation of the Dental Movements Caused by Oral Appliance in Syndrome Sleep Apnea Syndrome(DPOAM)

The DO OAM study is a mono-center, interventional, prospective study carried out in CH VALENCE.

It will estimate the prevalence of dental movements in patients treated by oral Appliance for Sleep Apnea syndrome.

The investigators will used fingerprinting technique by taking multiple photographs of the teeth that allow for the three-dimensional reconstruction of the teeth

this study will provide a better understanding of dental movement caused by oral appliance

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

oral appliances are indicated for the treatment of Sleep Apnea syndrome. Dentoskeletal effects of oral Appliance are imperfectly assessed.

the investigators want to study dental movements by comparing three-dimensional reconstruction of the teeth and the dental articulation in patients treated for sleep apnea syndrome in our Hospital.

The study consists of an additional acquisition of three-dimensional reconstruction of teeth.

the data previously acquired during the first digital impression according usual practise will be compared to this additional acquisition.

Study Type

Interventional

Enrollment (Actual)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Valence, France, 26000
        • CH Valence

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with a diagnosis of sleep apnea syndrome treated by Oral appliances in CH Valence
  • Availability of previous digital impressions required for Oral appliances manufacturing
  • Age ≥ 18 years old
  • Read, write and understand the French language

Exclusion Criteria:

  • Patient under guardianship, deprived of liberty, safeguard of justice
  • Refusal to participate in research

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: open label
Single Group Assignment
Other: prevention
dental digital fingerprinting
Other Names:
  • dental digital fingerprinting

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dental movement
Time Frame: 1 DAY at inclusion visit only
dental length rotation (mm)
1 DAY at inclusion visit only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Valence

Collaborators

Claude Bernard University

Investigators

  • Principal Investigator: Guillaume Buiret, CH Valence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2021

Primary Completion (Actual)

November 25, 2022

Study Completion (Actual)

December 25, 2022

Study Registration Dates

First Submitted

October 19, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (Actual)

December 9, 2021

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIPH-CHV-08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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