Laser Therapy and Temporomandibular Disorders
Primary Purpose
TMD
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Nd YAG laser
diode laser (980 nm)
diode laser (940 nm)
diode laser (660 nm)
diode laser (635 nm)
Sponsored by
About this trial
This is an interventional treatment trial for TMD
Eligibility Criteria
Inclusion Criteria: Pain at TMJ area. Pain at masseter and temporalis muscles. Age ranges between 20 and 40 years old. Presence of full or nearly full complement of natural teeth Exclusion Criteria: Patients who have radiographic evidence of degenerative conditions of TMJ. Patients under current dental or physical therapy that could affect TMD. History of recent trauma. The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis). Pregnant and lactating females
Sites / Locations
- Alexandria Faculty of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Nd YAG laser
Diode laser 980 nm
Diode laser 940 nm
Diode laser 660 nm
Diode laser 635 nm
Arm Description
Outcomes
Primary Outcome Measures
Change in Pain
Visual analogue scale of pain (VAS),using a 0-10-point scale 0 score means no pain" and score 10 means "worst pain
Chaneg in pressure pain threshold
The pressure pain threshold measurements for the trapezius, infraspinatus, and extensor carpi radialis muscles were performed at the center of the upper trapezius, at a position 2-3 fingers below the center of the spine of scapula, and at a position 3-4 fingers below the lateral epicondyle of the humerus, respectively. The pressure pain threshold of the extensor indicis proprius was measured by pressing toward the medial side of the radius from a position 3 fingers above the radial styloid process. The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt. After all 8 muscles were investigated, the subjects were allowed to rest for 5 min. This procedure was repeated a total of 3 times.
Change in Oral-health Related Quality of life (OHRQoL)
The OHIP-14 has 14 questions related to the evaluation of OHRQoL. The responses were recorded in a 5-point Likert scale ranging from never to very often (score is 0 to 4). Then, we calculated the total scores of all domains, and a higher score indicated poor OHRQoL. The highest possible total score of all the OHIP-14 domains is 56
Secondary Outcome Measures
Full Information
NCT ID
NCT05620758
First Posted
November 10, 2022
Last Updated
December 11, 2022
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT05620758
Brief Title
Laser Therapy and Temporomandibular Disorders
Official Title
Clinical Effectiveness of a Laser Therapy in Patients With Temporomandibular Disorders (A Randomized Clinical Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 30, 2022 (Actual)
Primary Completion Date
January 30, 2023 (Anticipated)
Study Completion Date
January 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
TMD involves a set of multiple clinical manifestations where the pain is prevalent. Treatment ideally should be noninvasive and innocuous such as photobiomodulation
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
TMD
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nd YAG laser
Arm Type
Experimental
Arm Title
Diode laser 980 nm
Arm Type
Experimental
Arm Title
Diode laser 940 nm
Arm Type
Experimental
Arm Title
Diode laser 660 nm
Arm Type
Experimental
Arm Title
Diode laser 635 nm
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Nd YAG laser
Intervention Description
patients from those diagnosed with TMD will receive Nd YAG laser 1064 nm
Intervention Type
Other
Intervention Name(s)
diode laser (980 nm)
Intervention Description
patients from those diagnosed with TMD will receive a diode laser (980 nm)
Intervention Type
Other
Intervention Name(s)
diode laser (940 nm)
Intervention Description
patients from those diagnosed with TMD will receive a diode laser (940 nm)
Intervention Type
Other
Intervention Name(s)
diode laser (660 nm)
Intervention Description
patients from those diagnosed with TMD will receive a diode laser (660 nm)
Intervention Type
Other
Intervention Name(s)
diode laser (635 nm)
Intervention Description
patients from those diagnosed with TMD will receive a diode laser (635 nm)
Primary Outcome Measure Information:
Title
Change in Pain
Description
Visual analogue scale of pain (VAS),using a 0-10-point scale 0 score means no pain" and score 10 means "worst pain
Time Frame
Baseline and 1 month
Title
Chaneg in pressure pain threshold
Description
The pressure pain threshold measurements for the trapezius, infraspinatus, and extensor carpi radialis muscles were performed at the center of the upper trapezius, at a position 2-3 fingers below the center of the spine of scapula, and at a position 3-4 fingers below the lateral epicondyle of the humerus, respectively. The pressure pain threshold of the extensor indicis proprius was measured by pressing toward the medial side of the radius from a position 3 fingers above the radial styloid process. The investigator placed the digital pressure algometer on a site to be inspected and pressed against the tester in a vertical direction while increasing the force at a constant rate of 1 kg/cm2. The investigator instructed the subjects to express pain either by saying "ouch" or raising their hands when only slight pain was felt. After all 8 muscles were investigated, the subjects were allowed to rest for 5 min. This procedure was repeated a total of 3 times.
Time Frame
Baseline and 1 month
Title
Change in Oral-health Related Quality of life (OHRQoL)
Description
The OHIP-14 has 14 questions related to the evaluation of OHRQoL. The responses were recorded in a 5-point Likert scale ranging from never to very often (score is 0 to 4). Then, we calculated the total scores of all domains, and a higher score indicated poor OHRQoL. The highest possible total score of all the OHIP-14 domains is 56
Time Frame
Baseline and 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pain at TMJ area.
Pain at masseter and temporalis muscles.
Age ranges between 20 and 40 years old.
Presence of full or nearly full complement of natural teeth
Exclusion Criteria:
Patients who have radiographic evidence of degenerative conditions of TMJ.
Patients under current dental or physical therapy that could affect TMD.
History of recent trauma.
The presence of systemic diseases (i.e. rheumatoid arthritis, osteoarthritis).
Pregnant and lactating females
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nermeen A Rady, phd
Phone
01223349577
Email
nermeen.rady@alexu.edu.eg
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nermeen A Rady, phd
Email
Abdallah.abdelaty@gmail.com
First Name & Middle Initial & Last Name & Degree
Nermeen A Rady, Phd
First Name & Middle Initial & Last Name & Degree
Mariam M Bahgat, MSc
12. IPD Sharing Statement
Learn more about this trial
Laser Therapy and Temporomandibular Disorders
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