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NCT Number: NCT05710952

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

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.

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Key information

Conditions

Temporomandibular Joint Disorders Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de soins dentaires

Montpellier, 34000, France

Location status: Recruiting

Location contact

Stéphane BARTHELEMI, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Review by Modjaw

Device

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Condylar courses homogeneity

    Time frame: Up to 24 months

    Qualitative comparison of the homogeneity of the condylar courses before and after treatment

  2. Condylar courses symmetry

    Time frame: Up to 24 months

    Qualitative comparison of the symmetry of the condylar symmetry before and after treatment

  3. Condylar courses straightness

    Time frame: Up to 24 months

    Qualitative comparison of the straightness of the condylar symmetry before and after treatment

  4. Amplitude of the condylar path

    Time frame: Up to 24 months

    Virtual path length in mm assessed by Modjaw

  5. Straightness of the condylar path

    Time frame: Up to 24 months

    Y-axis deviation in mm assessed by Modjaw

  6. Adverses events

    Time frame: Up to 24 months

    Adverse events will be assessed before and after treatment

  7. Pain assessment

    Time frame: Up to 24 months

    Pain is assessed by an analogic visual scale from 0 (no pain) to 10 (maximum pain)

Study contacts

Contact information is provided by the study sponsor or research team.

Clémence HERTEAU

CONTACT

[email protected]

+334 67 33 67 10

Stéphane BARTHELEMI, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: EMDJW

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Feb 2, 2023
Registry last updated
May 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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