Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

NCT01150110 | Completed Early Phase 1 DMC

• 1 other identifier: 432
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Temporomandibular Disorders

Keywords

Temporomandibular disorders; occlusal splints; electromyography; TMD (muscle and joint dysfunction); masseteres e anterior temporalis muscles.

Interventions

resilient occlusal splints DEVICE

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.

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

Germana De Villa camargos

Uberlândia, Minas Gerais, 39400-082, Brazil

Location

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Joint Diseases

Condition Hierarchy (Ancestors)

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

Study Officials

• Germana Camargos, academic

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 23, 2010
• First Posted: June 24, 2010
• Study Start: July 1, 2007
• Study Completion: July 1, 2008
• Last Updated: June 24, 2010

Record last verified: 2007-05

Locations

BR (1)