Impact of Orthodontic Treatment on the Temporomandibular Joints (TMJ) Assessed by Modjaw (EMDJW)
Primary Purpose
Temporomandibular Joint Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Review by Modjaw
Sponsored by
About this trial
This is an interventional diagnostic trial for Temporomandibular Joint Disorders focused on measuring Temporomandibular joint, Orthodontic, Modjaw, Orthodontic braces
Eligibility Criteria
Inclusion Criteria: Major patient (≥18 years) First dentofacial orthopedic consultation at the dental clinic of Montpellier Patient requiring multi-attachment orthodontic treatment (vestibular or lingual) for a duration ≤2 years Signed informed consent Exclusion Criteria: Syndromic patient Orthodontic treatment with aligners General joint or bone pathology Patients with oral hygiene incompatible with orthodontic treatment
Sites / Locations
- Centre de soins dentairesRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Braces
Arm Description
Patients will receive an orthodontic treatment with fixed braces for 12 to 24 months
Outcomes
Primary Outcome Measures
Gap reduction between the interincisive point in mouth opening and the ordinate axis
Define if there is an improvement in the straightness of the condylar path by measuring the gap between the interincisive point in mouth opening and the ordinate axis in mm assessed by Modjaw
Secondary Outcome Measures
Condylar courses homogeneity
Qualitative comparison of the homogeneity of the condylar courses before and after treatment
Condylar courses symmetry
Qualitative comparison of the symmetry of the condylar symmetry before and after treatment
Condylar courses straightness
Qualitative comparison of the straightness of the condylar symmetry before and after treatment
Amplitude of the condylar path
Virtual path length in mm assessed by Modjaw
Straightness of the condylar path
Y-axis deviation in mm assessed by Modjaw
Adverses events
Adverse events will be assessed before and after treatment
Pain assessment
Pain is assessed by an analogic visual scale from 0 (no pain) to 10 (maximum pain)
Full Information
NCT ID
NCT05710952
First Posted
January 12, 2023
Last Updated
February 15, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT05710952
Brief Title
Impact of Orthodontic Treatment on the Temporomandibular Joints (TMJ) Assessed by Modjaw
Acronym
EMDJW
Official Title
Impact of Orthodontic Treatment on the Temporomandibular Joints (TMJ) Assessed by Modjaw in Adults
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 7, 2023 (Actual)
Primary Completion Date
April 7, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to assess the correlation between orthodontic treatment and temporomandibular joint (TMJ). For that, an evaluation with a virtual articulator (Modjaw) is carried out before and after the treatment. The condylar course are compared. Furthermore, the eventual TMJ symptoms are also compared before and after.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Joint Disorders
Keywords
Temporomandibular joint, Orthodontic, Modjaw, Orthodontic braces
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Braces
Arm Type
Other
Arm Description
Patients will receive an orthodontic treatment with fixed braces for 12 to 24 months
Intervention Type
Device
Intervention Name(s)
Review by Modjaw
Intervention Description
A review by Modjaw's will be done before the braces treatment and after.
Primary Outcome Measure Information:
Title
Gap reduction between the interincisive point in mouth opening and the ordinate axis
Description
Define if there is an improvement in the straightness of the condylar path by measuring the gap between the interincisive point in mouth opening and the ordinate axis in mm assessed by Modjaw
Time Frame
Up to 24 months
Secondary Outcome Measure Information:
Title
Condylar courses homogeneity
Description
Qualitative comparison of the homogeneity of the condylar courses before and after treatment
Time Frame
Up to 24 months
Title
Condylar courses symmetry
Description
Qualitative comparison of the symmetry of the condylar symmetry before and after treatment
Time Frame
Up to 24 months
Title
Condylar courses straightness
Description
Qualitative comparison of the straightness of the condylar symmetry before and after treatment
Time Frame
Up to 24 months
Title
Amplitude of the condylar path
Description
Virtual path length in mm assessed by Modjaw
Time Frame
Up to 24 months
Title
Straightness of the condylar path
Description
Y-axis deviation in mm assessed by Modjaw
Time Frame
Up to 24 months
Title
Adverses events
Description
Adverse events will be assessed before and after treatment
Time Frame
Up to 24 months
Title
Pain assessment
Description
Pain is assessed by an analogic visual scale from 0 (no pain) to 10 (maximum pain)
Time Frame
Up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major patient (≥18 years)
First dentofacial orthopedic consultation at the dental clinic of Montpellier
Patient requiring multi-attachment orthodontic treatment (vestibular or lingual) for a duration ≤2 years
Signed informed consent
Exclusion Criteria:
Syndromic patient
Orthodontic treatment with aligners
General joint or bone pathology
Patients with oral hygiene incompatible with orthodontic treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clémence HERTEAU
Phone
+334 67 33 67 10
Email
c-herteau@chu-montpellier.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Stéphane BARTHELEMI, MD, PhD
Email
stephane.barthelemi@umontpellier.fr
Facility Information:
Facility Name
Centre de soins dentaires
City
Montpellier
ZIP/Postal Code
34000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane BARTHELEMI, MD
Email
stephane.barthelemi@umontpellier.fr
12. IPD Sharing Statement
Learn more about this trial
Impact of Orthodontic Treatment on the Temporomandibular Joints (TMJ) Assessed by Modjaw
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