NCT05710952

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress84%
Feb 2023Dec 2026

First Submitted

Initial submission to the registry

January 12, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

February 7, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

3.2 years

First QC Date

January 12, 2023

Last Update Submit

May 24, 2024

Conditions

Temporomandibular Joint Disorders

Keywords

Temporomandibular jointOrthodonticModjawOrthodontic braces

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Condylar courses homogeneity

    Up to 24 months

  • Condylar courses symmetry

    Up to 24 months

  • Condylar courses straightness

    Up to 24 months

  • Amplitude of the condylar path

    Up to 24 months

  • Straightness of the condylar path

    Up to 24 months

  • +2 more secondary outcomes

Study Arms (1)

Braces

OTHER

Patients will receive an orthodontic treatment with fixed braces for 12 to 24 months

Device: Review by Modjaw

Interventions

Review by ModjawDEVICE

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

Braces

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Syndromic patient
  • Orthodontic treatment with aligners
  • General joint or bone pathology
  • Patients with oral hygiene incompatible with orthodontic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de soins dentaires

Montpellier, 34000, France

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Central Study Contacts

Clémence HERTEAU

CONTACT

+334 67 33 67 10c-herteau@chu-montpellier.fr

Stéphane BARTHELEMI, MD, PhD

CONTACT

stephane.barthelemi@umontpellier.fr

Study Design

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

Study Record Dates

First Submitted

January 12, 2023

First Posted

February 2, 2023

Study Start

February 7, 2023

Primary Completion

April 7, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

FR(1)