Back to resultsProspective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)
Primary Purpose
Low Level Laser and Occlusal Splint
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Low Level Laser Therapy
Occlusal Splint Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Low Level Laser and Occlusal Splint focused on measuring Low Level Laser, Occlusal Splint, Temporomandibular Disfunction
Eligibility Criteria
Inclusion Criteria:
- Patients over the age of 18 who apply with Temporomandibular Joint (TMJ) problems
- Patients with pain in the joint and chewing muscle area
Exclusion Criteria:
- Syndromic patients
- Patients under the age of 18
- Patients with a history of orthognathic surgery
- Pregnants
- Antidepressant Users
- Patients Using Removable Dentures
- Patients who have had joint treatment in the past six months
Sites / Locations
- Istanbul University, Dentistry Faculty
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group of Low Level Laser Therapy
Group of Occlusal Splint Treatment
Arm Description
Outcomes
Primary Outcome Measures
Joint Pain Scale
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04456946
Brief Title
Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)
Official Title
Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
April 12, 2022 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
April 1, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
In the literature, there are no studies comparing the use of occlusal splint and Low Level Laser (LLL) in the treatment of Temporomandibular Disfunction (TMD) and including Ultrasonography (USG) in these parameters. In this study, it is aimed to contribute to the literature in terms of determining which treatment method is more effective by evaluating the changes in the needles muscles with the use of occlusal splints and LLL with USG and other parameters in certain periods, as well as evaluating which parameters are more effective.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Level Laser and Occlusal Splint
Keywords
Low Level Laser, Occlusal Splint, Temporomandibular Disfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group of Low Level Laser Therapy
Arm Type
Experimental
Arm Title
Group of Occlusal Splint Treatment
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Low Level Laser Therapy
Intervention Description
Low Level Laser Therapy
Intervention Type
Device
Intervention Name(s)
Occlusal Splint Treatment
Intervention Description
Occlusal Splint Treatment
Primary Outcome Measure Information:
Title
Joint Pain Scale
Description
Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) form will be used in our study
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients over the age of 18 who apply with Temporomandibular Joint (TMJ) problems
Patients with pain in the joint and chewing muscle area
Exclusion Criteria:
Syndromic patients
Patients under the age of 18
Patients with a history of orthognathic surgery
Pregnants
Antidepressant Users
Patients Using Removable Dentures
Patients who have had joint treatment in the past six months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmet Faruk Erturk, Assistant Professor
Organizational Affiliation
Biruni University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University, Dentistry Faculty
City
Istanbul
State/Province
Fatih
ZIP/Postal Code
34200
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Prospective Investigation of the Effects of Different Treatment Techniques on Myofascial Trigger Points in Patients With Temporomandibular Dysfunction (TMD)
We'll reach out to this number within 24 hrs