NCT05150470

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 25, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2022

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

October 19, 2021

Last Update Submit

September 5, 2025

Conditions

Sleep Apnea Syndromes

Keywords

oral appliancedental movement

Outcome Measures

Primary Outcomes (1)

  • dental movement

    dental length rotation (mm)

    1 DAY at inclusion visit only

Study Arms (1)

open label

OTHER

Single Group Assignment

Other: prevention

Interventions

preventionOTHER

dental digital fingerprinting

Also known as: dental digital fingerprinting
open label

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ch Valence

Valence, 26000, France

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Guillaume Buiret

    CH VALENCE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2021

First Posted

December 9, 2021

Study Start

November 25, 2021

Primary Completion

November 25, 2022

Study Completion

December 25, 2022

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)