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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 26, 2017
Sponsor:
Information provided by (Responsible Party):
Simone Saldanha Oliveira, Universidade Federal Fluminense

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.

Condition or disease Intervention/treatment Phase
Temporomandibular Disorder Other: Osteopathic Manipulative Treatment Other: Sham intervention Not Applicable

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 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.

Statistical analysis:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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 : July 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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;

  • Fourth Ventricle Compression;
  • Temporal release, Masseter release, Lateral pterygoid release -intraoral approach making use of latex glove;
  • Pterygopalatine suture technique;
  • Sphenopalatine ganglion technique;
  • Sphenopalatine ligament technique;
  • Pterygomandibular ligament technique;
  • Craniosacral balancing;

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • individuals who has diagnosis of Temporomandibular disorder.

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Contact: Simone S Oliveira, Doctor 55 21 2629-9920 simone_s_oliveira@hotmail.com
Contact: Felipe RT Goulart, Graduated 55 21 967390923 felipe.goulart@gmail.com

Locations
Brazil
Federal Fuminense University Recruiting
Niteroi, RJ, Brazil, 24020-140
Contact: Simone S Oliveira, Doctor    55 21 2629-9920    simone_s_oliveira@hotmail.com   
Sponsors and Collaborators
Universidade Federal Fluminense
Investigators
Principal Investigator: Felipe RT Goulart, Graduated Federal Fluminense University

Responsible Party: Simone Saldanha Oliveira, Professor, Universidade Federal Fluminense
ClinicalTrials.gov Identifier: NCT02991326     History of Changes
Other Study ID Numbers: Simone Oliveira
First Posted: December 13, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Simone Saldanha Oliveira, Universidade Federal Fluminense:
Osteopathic Manipulative Treatment
Temporomandibular Disorder

Additional relevant MeSH terms:
Disease
Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Pathologic Processes
Myofascial Pain Syndromes