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Effect of Massage Treatment in Temporomandibular Joint (TMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04132726
Recruitment Status : Completed
First Posted : October 21, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Merve Benli, Istanbul University

Study Description
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Brief Summary:
Temporomandibular disorders (TMD) have multiple and broad clinical effects on orofacial structures and are often diagnosed in patients with a prevalence of between 5% and 12%. Among treatment options, massage therapy is one of the common therapeutic procedures and allows interesting clinical outcomes by reducing TMD symptoms successfully. However, there has been no attempt to validate this knowledge. Thus, the aim of this study is to evaluate the effect of massage and its properties in patients with TMD.

Condition or disease Intervention/treatment Phase
Massage Therapy Temporomandibular Disorder Other: Massage therapy Other: non-effective treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effect of Massage Treatment in Patients With Temporomandibular Disorder
Actual Study Start Date : April 17, 2018
Actual Primary Completion Date : February 23, 2019
Actual Study Completion Date : October 2, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Test
Experimental group which employed with massage treatment
 Other: Massage therapy
Massage therapy performed by a physiotherapist
Placebo Comparator: Placebo
Placebo group which employed with non-effective treatment
 Other: non-effective treatment
non-effective treatment
No Intervention: Control
no treatment


Outcome Measures
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Primary Outcome Measures :
  1. Pain- Visual Analog Scale [ Time Frame: 12 weeks-14 weeks ]
    Self-reported pain values. High scores for pain mean worse outcome for the study.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Temporomandibular disorder-positive RDC/TMD examination for groups RDC/TMD Ia and RDC/TMD Ib,
  2. Patient agreement to participate in the experimental study.

Exclusion Criteria:

  1. RDC/TMD II and RDC/TMDIII,
  2. Drug and/or removable partial or total prosthesis wearers,
  3. Being submitted to any type of physiotherapeutic treatment,
  4. Incomplete dentition,
  5. History of systemic diseases as diabetes or arthritis,
  6. The occurrence of facial trauma,
  7. Refusal to assume responsibility with this research.
Contacts and Locations
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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): NCT04132726


Locations
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Turkey
Istanbul university,Faculty of Dentistry
Fatih, Turkey, 34452
Sponsors and Collaborators
Istanbul University
Investigators
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Principal Investigator: Merve Benli, Dr. Istanbul University
More Information
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Publications of Results:

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Responsible Party: Dr. Merve Benli, Asst.Prof.Dr., Istanbul University
ClinicalTrials.gov Identifier: NCT04132726    
Other Study ID Numbers: 192021
First Posted: October 21, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Merve Benli, Istanbul University:
Massage
Additional relevant MeSH terms:
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Temporomandibular Joint Disorders
Temporomandibular Joint Dysfunction Syndrome
Craniomandibular Disorders
Mandibular Diseases
Jaw Diseases
 Musculoskeletal Diseases
Joint Diseases
Muscular Diseases
Stomatognathic Diseases
Myofascial Pain Syndromes