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Clinical Trial 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.


Clinical Trial Description

approved 06/29/2011 ;


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02251015
Study type Interventional
Source University of Sao Paulo
Contact
Status Completed
Phase Phase 3
Start date July 2011
Completion date December 2012

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