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

Phase 3

Completed

• Conditions: Temporomandibular Disorders
• Interventions: Procedure: occlusal plate; Procedure: therapeutic exercises

• 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

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Exclusion Criteria

• Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
occlusal plate group	occlusal plate	36 getting occlusal splints - the splinted group was subjects that used occlusal plate under the occlusal stability criteria. The patients also received therapeutic exercises too. The plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.
occlusal plate group	therapeutic exercises	36 getting occlusal splints - the splinted group was subjects that used occlusal plate under the occlusal stability criteria. The patients also received therapeutic exercises too. The plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.
therapeutic exercises	therapeutic exercises	13 as control group - The control group got only orientation related to therapeutic exercises.The orientation for therapeutic exercises seek to correctly position the jaw in the resting position. Maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day.

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