Evaluation of the Dental Movements Caused by Oral Appliance in Sleep Apnea Syndrome (DPOAM)
Primary Purpose
Sleep Apnea Syndromes
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
prevention
Sponsored by
About this trial
This is an interventional prevention trial for Sleep Apnea Syndromes focused on measuring oral appliance, dental movement
Eligibility Criteria
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
Sites / Locations
- Ch Valence
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
open label
Arm Description
Single Group Assignment
Outcomes
Primary Outcome Measures
dental movement
dental length rotation (mm)
Secondary Outcome Measures
Full Information
NCT ID
NCT05150470
First Posted
October 19, 2021
Last Updated
August 28, 2023
Sponsor
Centre Hospitalier de Valence
Collaborators
Claude Bernard University
1. Study Identification
Unique Protocol Identification Number
NCT05150470
Brief Title
Evaluation of the Dental Movements Caused by Oral Appliance in Sleep Apnea Syndrome
Acronym
DPOAM
Official Title
Evaluation of the Dental Movements Caused by Oral Appliance in Syndrome Sleep Apnea Syndrome(DPOAM)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 25, 2021 (Actual)
Primary Completion Date
November 25, 2022 (Actual)
Study Completion Date
December 25, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier de Valence
Collaborators
Claude Bernard University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes
Keywords
oral appliance, dental movement
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open label
Arm Type
Other
Arm Description
Single Group Assignment
Intervention Type
Other
Intervention Name(s)
prevention
Other Intervention Name(s)
dental digital fingerprinting
Intervention Description
dental digital fingerprinting
Primary Outcome Measure Information:
Title
dental movement
Description
dental length rotation (mm)
Time Frame
1 DAY at inclusion visit only
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillaume Buiret
Organizational Affiliation
CH Valence
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch Valence
City
Valence
ZIP/Postal Code
26000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Dental Movements Caused by Oral Appliance in Sleep Apnea Syndrome
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