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

NCT02251015 | Completed Phase 3 DMC

• 1 other identifier: Postural balance
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Temporomandibular Disorders

Keywords

Postural balance; Temporomandibular disorders; splints

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

therapeutic exercises

ACTIVE COMPARATOR

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.

Procedure: therapeutic exercises

occlusal plate group

EXPERIMENTAL

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.

Procedure: occlusal plate; Procedure: therapeutic exercises

Interventions

occlusal plate PROCEDURE

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.

occlusal plate group

therapeutic exercises PROCEDURE

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.

occlusal plate group; therapeutic exercises

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnostic Criteria Temporomandibular Disorders and dentate subjects

You may not qualify if:

• Without Diagnostic Criteria Temporomandibular Disorders and edentulous subjects

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Universidade de São Paulo

São Paulo, São Paulo/SP, 05508-900, Brazil

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• Simone de Oliveira, PHD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Effects of the use of occlusal splint on the postural balance of individuals with temporomandibular disorder

Study Record Dates

• First Submitted: November 6, 2013
• First Posted: September 26, 2014
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: September 10, 2015

Record last verified: 2015-09

Locations

BR (1)