Consequences of Temporomandibular Disorder on Balance Control

Temporomandibular Disorder Clinical Trial

— DAM  

Official title:

Consequences of Temporomandibular Disorder on Balance Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03283839
• Other study ID #: 2016-A01317-44
• Status: Recruiting
• Phase: N/A
• First received: May 19, 2017
• Last updated: January 17, 2018
• Start date: June 19, 2017
• Est. completion date: June 25, 2020

Study information

• Verified date: January 2018
• Source: Central Hospital, Nancy, France
• Contact: Philippe PERRIN
• Phone: 00 33 3 83 15 49 68
• Email: philippe.perrin[@]univ-lorraine.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 25, 2020
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Disease
• Pathophysiology
• Temporomandibular Disorder
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• Therapy

Intervention

Diagnostic Test:
• Posturography
Evaluation of postural control and of orientation function

Locations

Country	Name	City	State
France	CHRU de NANCY	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	Balance function	Length and surface covered by the foot pressure center are measured	T0 and 2,3 and 5 months after the first evaluation
Secondary	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
Secondary	Pain	Visual Analog Scale (1 to 10)	T0 and 2,3 and 5 months after the first evaluation
Secondary	Tinnitus	Questionnaire	T0 and 2,3 and 5 months after the first evaluation