Consequences of Temporomandibular Disorder on Balance Control (DAM)

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.

Study Overview

• Status: Unknown
• Conditions: Temporomandibular Disorder; Pathophysiology; Therapy
• Intervention / Treatment: Diagnostic test: Posturography

Detailed Description

Primary objective: 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54000
    • Recruiting
    • CHRU de Nancy
    • Contact: Nathalie paoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Temporomandibular disorder	Diagnostic test: Posturography; Evaluation of postural control and of orientation function; Other Names: Orientation perception
Other: Without temporomandibular disorder	Diagnostic test: Posturography; Evaluation of postural control and of orientation function; Other Names: Orientation perception

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance function	Length and surface covered by the foot pressure center are measured	T0 and 2,3 and 5 months after the first evaluation
Orientation function	Orientation is evaluated by the angle between the direction (of the gravity or of a part of his body) indicated by the subject and the real direction. It is evaluated with the road and frame test.	T0 and 2,3 and 5 months after the first evaluation
Pain	Visual Analog Scale (1 to 10)	T0 and 2,3 and 5 months after the first evaluation
Tinnitus	Questionnaire	T0 and 2,3 and 5 months after the first evaluation

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2017
• Primary Completion (Anticipated): February 25, 2019
• Study Completion (Anticipated): June 25, 2020

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: September 12, 2017
• First Posted (Actual): September 14, 2017

Study Record Updates

• Last Update Posted (Actual): January 18, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Temporo-mandibular dysfunction; Balance control; Orientation function
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: 2016-A01317-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No