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OpenTrials
Completed

NCT Number: NCT04694040

Condylar Inclination Recorded With Modjaw® Device.

In oral rehabilitation, the integration into the digital flow of mandibular movements and the patient's individual reference planes optimizes the functional adaptation of prosthetic elements whose design is computer aided. The innovative Modjaw® device allows you to record and then virtually simulate mandibular movements.

This retrospective study aims to: 1) Test the reliability of the Modjaw® device; 2) Measure the condylar displacements of asymptomatic subjects for the arbitrary programming of simulators.

Kinematic recordings of 22 healthy volunteers (15F / 7H; mean age: 22.2 years) were analyzed. Two recording sessions were carried out within one month of each other, by three different operators; each subject was followed by the same operator during the first (E1) and the second (E2) recording. The values of sagittal condylar inclination (SCI) obtained in opening, protrusion, right-left mediotrusion were calculated at 3 and 5 mm of condylar displacement. The transverse condylar inclination (TCI) was calculated at 4mm.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de NICE - Hôpital St Roch

Nice, 06000, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

adult ;

Exclusion criteria

temporomandibular disorders (TMD symptom questionnaire)

Treatment and study plan

Modjaw® device

Device

Analysis of mandibular kinematics with Modjaw® device

Primary outcomes

  1. Reliability of recordings

    Time frame: 5 months

    The intra-class correlation coefficient (ICC) based on a one-way random-effects ANOVA was used to measure the repeatability of the recordings.

Secondary outcomes

  1. Mandibular motion

    Time frame: 5 months

    Sagittal and transversal condylar inclination mesured in degrees

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

Analysis of Mandibular Kinematics of a Group of Asymptomatic Subjects Recorded With the Modjaw® Device

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

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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