NCT04694040

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2019

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
Last Updated

January 5, 2021

Status Verified

December 1, 2020

Enrollment Period

4 months

First QC Date

December 31, 2020

Last Update Submit

December 31, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reliability of recordings

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

    5 months

Secondary Outcomes (1)

  • Mandibular motion

    5 months

Study Arms (1)

healthy adult volunteers showing no signs of temporomandibular disorders

Device: Modjaw® device

Interventions

Analysis of mandibular kinematics with Modjaw® device

healthy adult volunteers showing no signs of temporomandibular disorders

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

community sample

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de NICE - Hôpital St Roch

Nice, 06000, France

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

January 7, 2019

Primary Completion

April 30, 2019

Study Completion

April 30, 2019

Last Updated

January 5, 2021

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

No data sharing is planned

Locations