TMD: Effect of Massage Treatment in Temporomandibular Joint

• Sponsor: Istanbul University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04132726
• Collaborator: (none)
• Enrollment: 90
• Location: 1
• Arms: 3
• Actual Duration (Months): 17.5
• Patients Per Site Per Month: 5.1

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• 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: Apr 17, 2018
• Actual Primary Completion Date: Feb 23, 2019
• Actual Study Completion Date: Oct 2, 2019

Arms and Interventions

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

Primary Outcome Measures

1. Pain- Visual Analog Scale [12 weeks-14 weeks]

   Self-reported pain values. High scores for pain mean worse outcome for the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Istanbul university,Faculty of Dentistry	Fatih		Turkey	34452

Sponsors and Collaborators

• Istanbul University

Investigators

• Principal Investigator: Merve Benli, Dr., Istanbul University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Merve Benli, Asst.Prof.Dr., Istanbul University
• ClinicalTrials.gov Identifier: NCT04132726
• Other Study ID Numbers: 192021
• First Posted: Oct 21, 2019
• Last Update Posted: Oct 21, 2019
• Last Verified: Oct 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Dr. Merve Benli, Asst.Prof.Dr., Istanbul University: Massage
• Additional relevant MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Study Results

No Results Posted as of Oct 21, 2019