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

NCT ID: NCT05150470

Last Updated: 2025-09-08

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-25

Study Completion Date

2022-12-25

Brief Summary

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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

Detailed Description

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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.

Conditions

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Sleep Apnea Syndromes

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

cohort
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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open label

Single Group Assignment

Group Type OTHER

prevention

Intervention Type OTHER

dental digital fingerprinting

Interventions

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prevention

dental digital fingerprinting

Intervention Type OTHER

Other Intervention Names

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dental digital fingerprinting

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Claude Bernard University

OTHER

Sponsor Role collaborator

Centre Hospitalier de Valence

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guillaume Buiret

Role: PRINCIPAL_INVESTIGATOR

CH VALENCE

Locations

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Ch Valence

Valence, , France

Site Status

Countries

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France

Other Identifiers

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RIPH-CHV-08

Identifier Type: -

Identifier Source: org_study_id

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