- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01150110
Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)
June 23, 2010 updated by: Federal University of Uberlandia
Evaluation of Resilient Occlusal Splints in the Control of 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minas Gerais
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Uberlandia, Minas Gerais, Brazil, 39400-082
- Germana De Villa camargos
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 50 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Germana Camargos, academic, Federal University of Uberlandia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2007
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
June 23, 2010
First Submitted That Met QC Criteria
June 23, 2010
First Posted (Estimate)
June 24, 2010
Study Record Updates
Last Update Posted (Estimate)
June 24, 2010
Last Update Submitted That Met QC Criteria
June 23, 2010
Last Verified
May 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Stomatognathic Diseases
- Jaw Diseases
- Craniomandibular Disorders
- Mandibular Diseases
- Myofascial Pain Syndromes
- Disease
- Temporomandibular Joint Disorders
- Temporomandibular Joint Dysfunction Syndrome
- Anti-Infective Agents
- Dermatologic Agents
- Antifungal Agents
- Keratolytic Agents
- Salicylic Acid
Other Study ID Numbers
- 432
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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