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

Temporomandibular Joint Disorders Clinical Trial

— EMDJW  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05710952
• Other study ID #: RECHMPL22_0509
• Status: Recruiting
• Phase: N/A
• Start date: February 7, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Clémence HERTEAU
• Phone: +334 67 33 67 10
• Email: c-herteau[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 32
• Est. completion date: December 31, 2026
• Est. primary completion date: April 7, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Device:
• Review by Modjaw
A review by Modjaw's will be done before the braces treatment and after.

Locations

Country	Name	City	State
France	Centre de soins dentaires	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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