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

Temporomandibular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02251015
• Other study ID #: Postural balance
• Status: Completed
• Phase: Phase 3
• First received: November 6, 2013
• Last updated: September 9, 2015
• Start date: July 2011
• Est. completion date: December 2012

Study information

• Verified date: September 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

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.

Description:

approved 06/29/2011

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnostic Criteria Temporomandibular Disorders and dentate subjects

Exclusion Criteria:

• Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects

Study Design

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

Related Conditions & MeSH terms

• Disease
• Temporomandibular Disorders
• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome

Intervention

Procedure:
• occlusal plate
In 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. 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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade de São Paulo	São Paulo	São Paulo/SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	to investigate the effects of the use of occlusal splint over postural balance in individuals with signs and symptoms of temporomandibular disorder.	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.	twelve weeks	Yes