Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

June 23, 2010 updated by: Federal University of Uberlandia

Evaluation of Resilient Occlusal Splints in the Control of Patients With Temporomandibular Disorder (TMD)

The purpose of this study was to compare the effectiveness of soft occlusal splint therapy on the electromyographic activity of masticatory muscles (ateriors temporalis and masseter) before and after the application of a muscle relaxation splint. Electromyography recordings from the masseter and anterior temporalis muscles were analyzed quantitatively during maximal clench, rest and mastication usual, before and after the treatment without a splint. Ten patients whose chief complaint was Temporomandibular Disorders (TMD) were selected for the study. After the initial evaluations soft occlusal splints (muscle relaxation splints) were applied, and the patients were instructed to use the splints for four weeks. Surface electromyographic recordings were taken from each patient, as clinical evaluations of TMD (Index of Helkimo), both evaluations before the beginning of clinical therapy and after four weeks of wearing splints. The data obtained were analyzed by Wilcoxon´s and Friedman´s tests.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Minas Gerais
      • Uberlandia, Minas Gerais, Brazil, 39400-082
        • Germana De Villa camargos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 50 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with clinical and/or diagnosis of TMD
  • With complaints of muscle disorders and / or joint pain, pain symptoms
  • Presence of occlusal interferences
  • Minimum of 20 functional teeth in the oral cavity with subsequent bilateral occlusion

Exclusion Criteria:

  • Individuals with extensive dental flaws
  • Orthodontic treatment in progress
  • History of systemic diseases as advanced arthritis, diabetes and conservative and reversible treatments such as occlusal splints are recommended

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Germana Camargos, academic, Federal University of Uberlandia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

June 23, 2010

First Submitted That Met QC Criteria

June 23, 2010

First Posted (Estimate)

June 24, 2010

Study Record Updates

Last Update Posted (Estimate)

June 24, 2010

Last Update Submitted That Met QC Criteria

June 23, 2010

Last Verified

May 1, 2007

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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