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Clinical Trials/NCT02991326
NCT02991326
Completed
Not Applicable

Osteopathic Manipulative Treatment Effect in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints

Universidade Federal Fluminense1 site in 1 country18 target enrollmentDecember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Temporomandibular Disorder
Sponsor
Universidade Federal Fluminense
Enrollment
18
Locations
1
Primary Endpoint
Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

This study aim to contribute with the investigation of the therapeutic effect of osteopathic manipulative treatment in pain intensity and Quality of Life in individuals diagnosed with temporomandibular disorder who make use of occlusal splints.

Detailed Description

Objective: It is known the multifactorial etiology of Temporomandibular Disorders(TMD) which raises the need of a multidisciplinary approach for its treatment. Studies have presented good results about the use of occlusal splints along with other therapies. The Osteopathic Manipulative Treatment(OMT) has as characteristic the philosophy of global approach and precise functional diagnosis. Based on a lack of randomized blind trials about this subject, This study aim to contribute with the investigation of the therapeutic effect OMT in pain intensity and Quality of Life in participants diagnosed with TMD making use of occlusal splints. Methodology: This study is a randomized blind trial, with sample composed by 18 participants referred to the occlusion clinic of Fluminense Federal University (UFF), diagnosed by the team of dentists and interns of occlusion clinic through the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD). The participants will complete the Short Form 36 Health Survey(SF-36) to measure the quality of life, and pain intensity diagram with Numeric Rating Scale (NRS) to measure the pain intensity. The sample will be randomized into 2 groups (9 individuals for each): Test Group (TG) - patients subject to Clinical Treatment with splints (CT) offered at the Occlusion Clinic unit along with Osteopathic Manipulative Treatment - OMT. Control Group (CG) - patients subject only to CT and will receive a sham treatment that simulate the OMT to blind these participants. After the treatment, patients will be re-evaluated in 8 weeks' time. Statistical analysis: The SF-36 and the pain intensity and the most intense pain evaluation diagram with Numeric Rating Scale (NRS) will be performed by the Wilcoxon's non parametric test.

Registry
clinicaltrials.gov
Start Date
December 2016
End Date
May 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Simone Saldanha Oliveira

Professor

Universidade Federal Fluminense

Eligibility Criteria

Inclusion Criteria

  • individuals who has diagnosis of Temporomandibular disorder.

Exclusion Criteria

  • individuals who already has subjected to osteopathic manipulative treatment to temporomandibular disorder.

Outcomes

Primary Outcomes

Change from Numeric Rating Scale (NRS) to measure the pain intensity at 2 month

Time Frame: 2 months

The use of Numeric Rating Scale (NRS) to measure the pain intensity in each body area related by the individuals before and 2 months after the first intervention.

Secondary Outcomes

  • Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months(2 months)
  • Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months(2 months)

Study Sites (1)

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