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

Not Applicable

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Other: prevention

• Registration Number: NCT05150470
• Lead Sponsor: Centre Hospitalier de Valence

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-10-19
• Study Start: 2021-11-25
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-09
• Primary Completion: 2022-11-25
• Study Completion: 2022-12-25
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 180

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open label	prevention	Single Group Assignment

Primary Outcome Measures

Name	Time	Method
dental movement	1 DAY at inclusion visit only	dental length rotation (mm)

Trial Locations

Locations (1)

Ch Valence; 🇫🇷 Valence, France