Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01150110
Recruitment Status : Completed
First Posted : June 24, 2010
Last Update Posted : June 24, 2010
Information provided by:
Federal University of Uberlandia

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Disorders Device: resilient occlusal splints Early Phase 1

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Evaluation of Resilient Occlusal Splints in the Control of Patients With Temporomandibular Disorder (TMD)
Study Start Date : July 2007
Actual Study Completion Date : July 2008

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U.S. FDA Resources

Intervention Details:
    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.

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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01150110

Germana De Villa camargos
Uberlandia, Minas Gerais, Brazil, 39400-082
Sponsors and Collaborators
Federal University of Uberlandia
Principal Investigator: Germana Camargos, academic Federal University of Uberlandia Identifier: NCT01150110     History of Changes
Other Study ID Numbers: 432
First Posted: June 24, 2010    Key Record Dates
Last Update Posted: June 24, 2010
Last Verified: May 2007

Keywords provided by Federal University of Uberlandia:
Temporomandibular disorders
occlusal splints
TMD (muscle and joint dysfunction)
masseteres e anterior temporalis muscles.

Additional relevant MeSH terms:
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Pathologic Processes
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes
Salicylic Acid
Anti-Infective Agents
Antifungal Agents
Keratolytic Agents
Dermatologic Agents