Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

NCT ID: NCT01150110

Last Updated: 2010-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Temporomandibular Disorders

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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resilient occlusal splints

A resilient occlusal splints (silicone 2mm) was fabricated on the maxillary arch, using a vacuum pressing machine. The occlusal splints were adjusted to eliminate the gross interferences and to obtain occlusal stability with maximum posterior bilateral contacts.

Patients were instructed to use the occlusal splints for 24 hours during 30 days. The use was interrupted only during meals.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Uberlandia

OTHER

Sponsor Role lead

Principal Investigators

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Germana Camargos, academic

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

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Germana De Villa camargos

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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432

Identifier Type: -

Identifier Source: org_study_id

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