Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

Temporomandibular Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150110
• Other study ID #: 432
• Status: Completed
• Phase: Phase 0
• First received: June 23, 2010
• Last updated: June 23, 2010
• Start date: July 2007
• Est. completion date: July 2008

Study information

• Verified date: May 2007
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Comitê de ética em pesquisa
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: July 2008
• Gender: Both
• Age group: 19 Years to 50 Years

Eligibility

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 Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Germana De Villa camargos	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil,