- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03283839
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
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Philippe PERRIN
- Phone Number: 00 33 3 83 15 49 68
- Email: philippe.perrin@univ-lorraine.fr
Study Contact Backup
- Name: Nathalie PAOLI
- Phone Number: 00 33 3 83 15 49 68
- Email: nathalie.paoli@univ-lorraine.fr
Study Locations
-
-
-
Nancy, France, 54000
- Recruiting
- CHRU de Nancy
-
Contact:
- Nathalie paoli
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Temporomandibular disorder
|
Evaluation of postural control and of orientation function
Other Names:
|
Other: Without temporomandibular disorder
|
Evaluation of postural control and of orientation function
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At inclusion (before care for patients) (first evaluation)
|
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.
|
2 months after the first evaluation
|
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.
|
3 months after the first evaluation
|
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.
|
5 months after the first evaluation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
T0 and 2,3 and 5 months after the first evaluation
|
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.
|
T0 and 2,3 and 5 months after the first evaluation
|
Pain
Time Frame: T0 and 2,3 and 5 months after the first evaluation
|
Visual Analog Scale (1 to 10)
|
T0 and 2,3 and 5 months after the first evaluation
|
Tinnitus
Time Frame: T0 and 2,3 and 5 months after the first evaluation
|
Questionnaire
|
T0 and 2,3 and 5 months after the first evaluation
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016-A01317-44
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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