Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints
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|ClinicalTrials.gov Identifier: NCT02991326|
Recruitment Status : Recruiting
First Posted : December 13, 2016
Last Update Posted : October 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Temporomandibular Disorder||Other: Osteopathic Manipulative Treatment Other: Sham intervention||Not Applicable|
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.
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 Visual Analogic Scale (VAS) 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.
The SF-36 will be performed by the Wilcoxon's non parametric test, the pain intensity diagram with Visual Analogic Scale (VAS) will be performed by the Sign test, and the most intense pain evaluation in diagram with VAS by the Student's T test.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Osteopathic Manipulative Treatment Effect in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints|
|Study Start Date :||April 2016|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||July 2019|
Experimental: Test Group (TG)
The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to Osteopathic Manipulative Treatment - OMT.
Other: Osteopathic Manipulative Treatment
The Osteopathic manipulative treatment will follow the approach bellow;
Sham Comparator: Control Group (CG)
The Individuals who already is subject to Clinical Treatment with splints offered at the Occlusion Clinic will be subject to sham intervention (Osteopathic Manipulative Treatment simulated).
Other: Sham intervention
The sham intervention will be made in the same examination table and the same position, with the use of the latex gloves, to simulate the Osteopathic Manipulative Treatment, only doing simple touches without therapeutic effect intention.
- Change from Visual Analogic Scale (VAS) to measure the pain intensity at 2 month [ Time Frame: 2 months ]The use of visual analogic scale to measure the pain intensity in each body area related by the individuals before and 2 months after first intervention.
- Change from Visual Analogic Scale (VAS) for the body area with the most intense pain at 2 months [ Time Frame: 2 months ]The use of visual analogic scale to measure de pain intensity in the body area related by the individuals with the most intensity pain before and 2 months after first intervention.
- Change from Quality of Life Survey by Short Form 36 Health Survey(SF-36) at 2 months [ Time Frame: 2 months ]The use of SF36 to measure the score of quality of life before and 2 months after first intervention.
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 ClinicalTrials.gov identifier (NCT number): NCT02991326
|Contact: Simone S Oliveira, Doctor||55 21 firstname.lastname@example.org|
|Contact: Felipe RT Goulart, Graduated||55 21 email@example.com|
|Federal Fuminense University||Recruiting|
|Niteroi, RJ, Brazil, 24020-140|
|Contact: Simone S Oliveira, Doctor 55 21 2629-9920 firstname.lastname@example.org|
|Principal Investigator:||Felipe RT Goulart, Graduated||Federal Fluminense University|