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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05150470
Other study ID # 0003
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 25, 2021
Est. completion date December 25, 2022

Study information

Verified date August 2023
Source Centre Hospitalier de Valence
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 180
Est. completion date December 25, 2022
Est. primary completion date November 25, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Other:
prevention
dental digital fingerprinting

Locations

Country Name City State
France Ch Valence Valence

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier de Valence Claude Bernard University

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary dental movement dental length rotation (mm) 1 DAY at inclusion visit only
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