Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Consequences of Temporomandibular Disorder on Balance Control (DAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 19, 2017
First Posted Date  ICMJE September 14, 2017
Last Update Posted Date January 18, 2018
Actual Study Start Date  ICMJE June 19, 2017
Estimated Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
  • Postural control (before care for patients) [ Time Frame: At inclusion (T0: before care) ]
    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
  • Postural control (during care for patients) [ Time Frame: 2 months after T0 evaluation ]
    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
  • Postural control (during care for patients) [ Time Frame: 3 months after T0 evaluation ]
    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
  • Postural control (during care for patients) [ Time Frame: 5 months after T0 evaluation ]
    Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Change History Complete list of historical versions of study NCT03283839 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2017)
  • 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
  • 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.
  • Pain [ Time Frame: T0 and 2,3 and 5 months after the first evaluation ]
    Visual Analog Scale (1 to 10)
  • Tinnitus [ Time Frame: T0 and 2,3 and 5 months after the first evaluation ]
    Questionnaire
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2017)
  • Balance function [ Time Frame: T0 and 2,3 and 5 months after the first evaluation (T0) ]
    Length and surface covered by the foot pressure center are measured
  • Orientation function [ Time Frame: T0 and 2,3 and 5 months after the first evaluation (T0) ]
    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.
  • Pain [ Time Frame: T0 and 2,3 and 5 months after the first evaluation (T0) ]
    Visual Analog Scale (1 to 10)
  • Tinnitus [ Time Frame: T0 and 2,3 and 5 months after the first evaluation (T0) ]
    Questionnaire
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Consequences of Temporomandibular Disorder on Balance Control
Official Title  ICMJE Consequences of Temporomandibular Disorder on Balance Control
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Temporomandibular Disorder
  • Pathophysiology
  • Therapy
Intervention  ICMJE Diagnostic Test: Posturography
Evaluation of postural control and of orientation function
Other Name: Orientation perception
Study Arms  ICMJE
  • Temporomandibular disorder
    Intervention: Diagnostic Test: Posturography
  • Without temporomandibular disorder
    Intervention: Diagnostic Test: Posturography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 12, 2017)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 25, 2020
Estimated Primary Completion Date February 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03283839
Other Study ID Numbers  ICMJE 2016-A01317-44
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Central Hospital, Nancy, France
Study Sponsor  ICMJE Central Hospital, Nancy, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Central Hospital, Nancy, France
Verification Date January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP