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Clinical Trials/NCT02251015
NCT02251015
Completed
Phase 3

Evaluation of Postural Balance in Individuals With Temporomandibular Disorder by Means of Force Platform After Using Occlusal Stabilizer Splint Disorder

University of Sao Paulo1 site in 1 country49 target enrollmentJuly 2011

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Temporomandibular Disorders
Sponsor
University of Sao Paulo
Enrollment
49
Locations
1
Primary Endpoint
to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

To investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder. The research group consists of 49 patients (36 getting occlusal splints and 13 as control group) between 18 and 75 years old, both genders, diagnosed as temporomandibular disorder (TMD) by RDC/TMD questionnaire and magnetic resonance imaging of the temporomandibular joints. The research is a randomized, controlled, prospective clinical study with intervention. Postural equilibrium will be evaluated by means of a force plate. In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation about therapeutic exercises. After 12 weeks, the groups were re-evaluated. The results will be analyzed by categorical data using absolute and relative frequencies as well as continuous data using average, median, standard deviation, 25 and 75 percentiles, besides minimum and maximum values; comparison between the times by non-parametric Wilcoxon, Mann-Whitney and ANOVA tests with a threshold of significance of 0.05.

Detailed Description

approved 06/29/2011

Registry
clinicaltrials.gov
Start Date
July 2011
End Date
December 2012
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Simone Saldanha Ignacio de Oliveira

Effects of the use of occlusal splint on the postural balance of individuals with temporomandibular disorder

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Diagnostic Criteria Temporomandibular Disorders and dentate subjects

Exclusion Criteria

  • Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects

Outcomes

Primary Outcomes

to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.

Time Frame: twelve weeks

Postural equilibrium was evaluated by means of a force plate. In the randomization, the splinted group was under an occlusal-stability criterion as well as advised under therapeutic exercises while the control group got only orientation related to therapeutic exercises.

Study Sites (1)

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