Impact of Orthodontic Treatment on the Temporomandibular Joints (TMJ) Assessed by Modjaw (EMDJW)

May 24, 2024 updated by: University Hospital, Montpellier

Impact of Orthodontic Treatment on the Temporomandibular Joints (TMJ) Assessed by Modjaw in Adults

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Braces
Patients will receive an orthodontic treatment with fixed braces for 12 to 24 months
Device: Review by Modjaw
A review by Modjaw's will be done before the braces treatment and after.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gap reduction between the interincisive point in mouth opening and the ordinate axis
Time Frame: Up to 24 months
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
Up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Condylar courses homogeneity
Time Frame: Up to 24 months
Qualitative comparison of the homogeneity of the condylar courses before and after treatment
Up to 24 months
Condylar courses symmetry
Time Frame: Up to 24 months
Qualitative comparison of the symmetry of the condylar symmetry before and after treatment
Up to 24 months
Condylar courses straightness
Time Frame: Up to 24 months
Qualitative comparison of the straightness of the condylar symmetry before and after treatment
Up to 24 months
Amplitude of the condylar path
Time Frame: Up to 24 months
Virtual path length in mm assessed by Modjaw
Up to 24 months
Straightness of the condylar path
Time Frame: Up to 24 months
Y-axis deviation in mm assessed by Modjaw
Up to 24 months
Adverses events
Time Frame: Up to 24 months
Adverse events will be assessed before and after treatment
Up to 24 months
Pain assessment
Time Frame: Up to 24 months
Pain is assessed by an analogic visual scale from 0 (no pain) to 10 (maximum pain)
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2023

Primary Completion (Estimated)

April 7, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

January 12, 2023

First Submitted That Met QC Criteria

January 26, 2023

First Posted (Actual)

February 2, 2023

Study Record Updates

Last Update Posted (Actual)

May 28, 2024

Last Update Submitted That Met QC Criteria

May 24, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RECHMPL22_0509

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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