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Consequences of Temporomandibular Disorder on Balance Control (DAM)

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ClinicalTrials.gov Identifier: NCT03283839
Recruitment Status : Recruiting
First Posted : September 14, 2017
Last Update Posted : January 18, 2018
Sponsor:
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.


Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Pathophysiology Therapy Diagnostic Test: Posturography Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Consequences of Temporomandibular Disorder on Balance Control
Actual Study Start Date : June 19, 2017
Estimated Primary Completion Date : February 25, 2019
Estimated Study Completion Date : June 25, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Temporomandibular disorder Diagnostic Test: Posturography
Evaluation of postural control and of orientation function
Other Name: Orientation perception

Without temporomandibular disorder Diagnostic Test: Posturography
Evaluation of postural control and of orientation function
Other Name: Orientation perception




Primary Outcome Measures :
  1. Postural control (before care for patients) [ Time Frame: At inclusion (before care for patients) (first evaluation) ]
    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

  2. Postural control (during care for patients) [ Time Frame: 2 months after the first evaluation ]
    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

  3. Postural control (during care for patients) [ Time Frame: 3 months after the first evaluation ]
    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.

  4. Postural control (during care for patients) [ Time Frame: 5 months after the first evaluation ]
    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.


Secondary Outcome Measures :
  1. Balance function [ Time Frame: T0 and 2,3 and 5 months after the first evaluation ]
    Length and surface covered by the foot pressure center are measured

  2. Orientation function [ Time Frame: T0 and 2,3 and 5 months after the first evaluation ]
    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.

  3. Pain [ Time Frame: T0 and 2,3 and 5 months after the first evaluation ]
    Visual Analog Scale (1 to 10)

  4. Tinnitus [ Time Frame: T0 and 2,3 and 5 months after the first evaluation ]
    Questionnaire



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03283839


Contacts
Contact: Philippe PERRIN 00 33 3 83 15 49 68 philippe.perrin@univ-lorraine.fr
Contact: Nathalie PAOLI 00 33 3 83 15 49 68 nathalie.paoli@univ-lorraine.fr

Locations
France
CHRU de NANCY Recruiting
Nancy, France, 54000
Contact: Nathalie paoli         
Sponsors and Collaborators
Central Hospital, Nancy, France

Responsible Party: Central Hospital, Nancy, France
ClinicalTrials.gov Identifier: NCT03283839     History of Changes
Other Study ID Numbers: 2016-A01317-44
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Central Hospital, Nancy, France:
Temporo-mandibular dysfunction
Balance control
Orientation function

Additional relevant MeSH terms:
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Pathologic Processes
Myofascial Pain Syndromes