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

U

University of Sao Paulo

Status and phase

Completed
Phase 3

Conditions

Temporomandibular Disorders

Treatments

Procedure: occlusal plate
Procedure: therapeutic exercises

Study type

Interventional

Funder types

Other

Identifiers

NCT02251015
Postural balance

Details and patient eligibility

About

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.

Full description

approved 06/29/2011

Enrollment

49 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnostic Criteria Temporomandibular Disorders and dentate subjects

Exclusion criteria

  • Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

49 participants in 2 patient groups

therapeutic exercises
Active Comparator group
Description:
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.
Treatment:
Procedure: therapeutic exercises
occlusal plate group
Experimental group
Description:
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.
Treatment:
Procedure: therapeutic exercises
Procedure: occlusal plate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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