Effects of the Use of Occlusal Splint on the Postural Balance of Individuals With Temporomandibular Disorder

Phase 3

Completed

• Conditions: Temporomandibular Disorders

• Registration Number: NCT02251015
• Lead Sponsor: University of Sao Paulo

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

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2012-12
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2014-09-24
• Study First Posted: 2014-09-26
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-09
• Last Update Posted: 2015-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

• Diagnostic Criteria Temporomandibular Disorders and dentate subjects

Exclusion Criteria

• Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Universidade de São Paulo; 🇧🇷 São Paulo, São Paulo/SP, Brazil