Osteopathic Manipulative Treatment in Individuals With Temporomandibular Disorder Who Make Use of Occlusal Splints
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|ClinicalTrials.gov Identifier: NCT02991326|
Recruitment Status : Completed
First Posted : December 13, 2016
Last Update Posted : May 20, 2019
|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 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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual 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|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||December 2018|
|Actual Study Completion Date :||May 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 (using latex gloves for intra oral techniques):
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 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.
- Change from Numeric Rating Scale (NRS) for the body area with the Worst Pain(WP) at 2 months [ Time Frame: 2 months ]The use of Numeric Rating Scale (NRS) to measure de pain intensity in the body area with the most intensity pain related by the individuals 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
|Federal Fuminense University|
|Niteroi, RJ, Brazil, 24020-140|
|Principal Investigator:||Felipe RT Goulart, Graduated||Federal Fluminense University|