Back to resultsConsequences of Temporomandibular Disorder on Balance Control (DAM)
Primary Purpose
Temporomandibular Disorder, Pathophysiology, Therapy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Posturography
Sponsored by
About this trial
This is an interventional diagnostic trial for Temporomandibular Disorder focused on measuring Temporo-mandibular dysfunction, Balance control, Orientation function
Eligibility 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.
Sites / Locations
- CHRU de NANCYRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Temporomandibular disorder
Without temporomandibular disorder
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
Balance function
Length and surface covered by the foot pressure center are measured
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.
Pain
Visual Analog Scale (1 to 10)
Tinnitus
Questionnaire
Full Information
NCT ID
NCT03283839
First Posted
May 19, 2017
Last Updated
January 17, 2018
Sponsor
Central Hospital, Nancy, France
1. Study Identification
Unique Protocol Identification Number
NCT03283839
Brief Title
Consequences of Temporomandibular Disorder on Balance Control
Acronym
DAM
Official Title
Consequences of Temporomandibular Disorder on Balance Control
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
February 25, 2019 (Anticipated)
Study Completion Date
June 25, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorder, Pathophysiology, Therapy
Keywords
Temporo-mandibular dysfunction, Balance control, Orientation function
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Temporomandibular disorder
Arm Type
Other
Arm Title
Without temporomandibular disorder
Arm Type
Other
Intervention Type
Diagnostic Test
Intervention Name(s)
Posturography
Other Intervention Name(s)
Orientation perception
Intervention Description
Evaluation of postural control and of orientation function
Primary Outcome Measure Information:
Title
Postural control (before care for patients)
Description
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Time Frame
At inclusion (before care for patients) (first evaluation)
Title
Postural control (during care for patients)
Description
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Time Frame
2 months after the first evaluation
Title
Postural control (during care for patients)
Description
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Time Frame
3 months after the first evaluation
Title
Postural control (during care for patients)
Description
Postural control is evaluate by the average of condition 5 and 6 of the sensory organisation test (SOT) measured on Equitest plateform.
Time Frame
5 months after the first evaluation
Secondary Outcome Measure Information:
Title
Balance function
Description
Length and surface covered by the foot pressure center are measured
Time Frame
T0 and 2,3 and 5 months after the first evaluation
Title
Orientation function
Description
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.
Time Frame
T0 and 2,3 and 5 months after the first evaluation
Title
Pain
Description
Visual Analog Scale (1 to 10)
Time Frame
T0 and 2,3 and 5 months after the first evaluation
Title
Tinnitus
Description
Questionnaire
Time Frame
T0 and 2,3 and 5 months after the first evaluation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe PERRIN
Phone
00 33 3 83 15 49 68
Email
philippe.perrin@univ-lorraine.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Nathalie PAOLI
Phone
00 33 3 83 15 49 68
Email
nathalie.paoli@univ-lorraine.fr
Facility Information:
Facility Name
CHRU de NANCY
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nathalie paoli
12. IPD Sharing Statement
Plan to Share IPD
No
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Consequences of Temporomandibular Disorder on Balance Control
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