Condylar Inclination Recorded With Modjaw® Device.

Completed

• Conditions: Temporomandibular Disorder
• Interventions: Device: Modjaw® device

• Registration Number: NCT04694040
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-07
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2020-12
• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Last Update Submitted: 2020-12-31
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
healthy adult volunteers showing no signs of temporomandibular disorders	Modjaw® device	-

Primary Outcome Measures

Name	Time	Method
Reliability of recordings	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 Outcome Measures

Name	Time	Method
Mandibular motion	5 months	Sagittal and transversal condylar inclination mesured in degrees

Trial Locations

Locations (1)

CHU de NICE - Hôpital St Roch; 🇫🇷 Nice, France