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Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

Primary Purpose

Temporomandibular Disorders

Status
Completed
Phase
Early Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
resilient occlusal splints
Sponsored by
Federal University of Uberlandia
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Temporomandibular Disorders focused on measuring Temporomandibular disorders, occlusal splints, electromyography, TMD (muscle and joint dysfunction), masseteres e anterior temporalis muscles.

Eligibility Criteria

19 Years - 50 Years (Adult)All Sexes

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

Sites / Locations

  • Germana De Villa camargos

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 23, 2010
Last Updated
June 23, 2010
Sponsor
Federal University of Uberlandia
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1. Study Identification

Unique Protocol Identification Number
NCT01150110
Brief Title
Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)
Official Title
Evaluation of Resilient Occlusal Splints in the Control of Patients With Temporomandibular Disorder (TMD)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Federal University of Uberlandia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Temporomandibular Disorders
Keywords
Temporomandibular disorders, occlusal splints, electromyography, TMD (muscle and joint dysfunction), masseteres e anterior temporalis muscles.

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
resilient occlusal splints
Intervention Description
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
50 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Germana Camargos, academic
Organizational Affiliation
Federal University of Uberlandia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Germana De Villa camargos
City
Uberlandia
State/Province
Minas Gerais
ZIP/Postal Code
39400-082
Country
Brazil

12. IPD Sharing Statement

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Resilient Occlusal and Patients With Temporomandibular Disorder (TMD)

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