NCT03283839

Brief Summary

To evaluate the effects of the temporomandibular disorder (TMD) and its therapeutic care on postural control in somato-sensory and visual sensitization compared to control subjects matched on age, sex and lifestyle. Parameters will be estimated by measures realized before the therapeutic care of the TMD (T0), then 2, 3 and 5 months after the starting care, both in TMD patients and control subjects. To evaluate also the effects of the TMD and its therapeutic care on balance control in various contexts of multi-sensory stimulation, orientation function, pain and tinnitus.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2017

Completed
1 month until next milestone

Study Start

First participant enrolled

June 19, 2017

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 14, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2020

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1.7 years

First QC Date

May 19, 2017

Last Update Submit

January 17, 2018

Conditions

Temporomandibular DisorderPathophysiologyTherapy

Keywords

Temporo-mandibular dysfunctionBalance controlOrientation function

Outcome Measures

Primary Outcomes (4)

  • Postural control (before care for patients)

    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

    At inclusion (before care for patients) (first evaluation)

  • Postural control (during care for patients)

    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

    2 months after the first evaluation

  • Postural control (during care for patients)

    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

    3 months after the first evaluation

  • Postural control (during care for patients)

    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

    5 months after the first evaluation

Secondary Outcomes (4)

  • Balance function

    T0 and 2,3 and 5 months after the first evaluation

  • Orientation function

    T0 and 2,3 and 5 months after the first evaluation

  • Pain

    T0 and 2,3 and 5 months after the first evaluation

  • Tinnitus

    T0 and 2,3 and 5 months after the first evaluation

Study Arms (2)

Temporomandibular disorder

OTHER
Diagnostic Test: Posturography

Without temporomandibular disorder

OTHER
Diagnostic Test: Posturography

Interventions

PosturographyDIAGNOSTIC_TEST

Evaluation of postural control and of orientation function

Also known as: Orientation perception
Temporomandibular disorderWithout temporomandibular disorder

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient group: TMD patients, care: occlusal splint therapy, behavioral advices
  • Control group: matched with TMD patients (age, sex, lifestyle).

You may not qualify if:

  • Patient group: treatment generating secondary effects in postural control (psychotrop, antidepressor, antihypertensive drugs); osteoarticular pathologies and recent trauma (\< 4 months); vertigo and dysequilibrium (\< 6 months), whiplash
  • Control group: id. and TMD.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de NANCY

Nancy, 54000, France

RECRUITING

MeSH Terms

Conditions

Temporomandibular Joint DisordersOrientation, Spatial

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesSpatial BehaviorBehavior

Central Study Contacts

Philippe PERRIN

CONTACT

00 33 3 83 15 49 68philippe.perrin@univ-lorraine.fr

Nathalie PAOLI

CONTACT

00 33 3 83 15 49 68nathalie.paoli@univ-lorraine.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2017

First Posted

September 14, 2017

Study Start

June 19, 2017

Primary Completion

February 25, 2019

Study Completion

June 25, 2020

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)