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Clinical Trials/NCT04694040
NCT04694040CompletedNot Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country22 target enrollmentStarted: January 7, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
22
Locations
1
Primary Endpoint
Reliability of recordings

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

  • Mandibular motion(5 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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