Laser Therapy and Temporomandibular Disorders

TMD Clinical Trial

Official title:

Clinical Effectiveness of a Laser Therapy in Patients With Temporomandibular Disorders (A Randomized Clinical Trial)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05620758
• Other study ID #: TMD_Laser_2022
• Status: Recruiting
• Phase: N/A
• Start date: November 30, 2022
• Est. completion date: January 30, 2023

Study information

• Verified date: December 2022
• Source: Alexandria University
• Contact: Nermeen A Rady, phd
• Phone: 01223349577
• Email: nermeen.rady[@]alexu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

TMD involves a set of multiple clinical manifestations where the pain is prevalent. Treatment ideally should be noninvasive and innocuous such as photobiomodulation

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 30, 2023
• Est. primary completion date: January 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Temporomandibular Joint Disorders
• Temporomandibular Joint Dysfunction Syndrome
• TMD

Intervention

Other:
• Nd YAG laser
patients from those diagnosed with TMD will receive Nd YAG laser 1064 nm
• diode laser (980 nm)
patients from those diagnosed with TMD will receive a diode laser (980 nm)
• diode laser (940 nm)
patients from those diagnosed with TMD will receive a diode laser (940 nm)
• diode laser (660 nm)
patients from those diagnosed with TMD will receive a diode laser (660 nm)
• diode laser (635 nm)
patients from those diagnosed with TMD will receive a diode laser (635 nm)

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Dentistry	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline and 1 month
Primary	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.	Baseline and 1 month
Primary	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	Baseline and 1 month