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Completed

NCT Number: NCT01150110

Resilient Occlusal and 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.

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Key information

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Germana De Villa camargos

Uberlândia, Minas Gerais, 39400-082, Brazil

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Sponsors and collaborators

Lead sponsor

Federal University of Uberlandia

Other

Registry information

Official study title

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

Important dates

Study start
2007
Study completion
2008
First posted
Jun 24, 2010
Registry last updated
Jun 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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