Laser Therapy and Temporomandibular Disorders

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

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

Study Overview

• Status: Recruiting
• Conditions: TMD
• Intervention / Treatment: Other: Nd YAG laser; Other: diode laser (980 nm); Other: diode laser (940 nm); Other: diode laser (660 nm); Other: diode laser (635 nm)

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nermeen A Rady, phd; Phone Number: 01223349577; Email: nermeen.rady@alexu.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria Faculty of Dentistry
    • Contact: Nermeen A Rady, phd; Email: Abdallah.abdelaty@gmail.com
    • Principal Investigator: Nermeen A Rady, Phd
    • Sub-Investigator: Mariam M Bahgat, MSc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nd YAG laser	Other: Nd YAG laser; patients from those diagnosed with TMD will receive Nd YAG laser 1064 nm
Experimental: Diode laser 980 nm	Other: diode laser (980 nm); patients from those diagnosed with TMD will receive a diode laser (980 nm)
Experimental: Diode laser 940 nm	Other: diode laser (940 nm); patients from those diagnosed with TMD will receive a diode laser (940 nm)
Experimental: Diode laser 660 nm	Other: diode laser (660 nm); patients from those diagnosed with TMD will receive a diode laser (660 nm)
Experimental: Diode laser 635 nm	Other: diode laser (635 nm); patients from those diagnosed with TMD will receive a diode laser (635 nm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Hams Hamed Abdelrahman

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2022
• Primary Completion (Anticipated): January 30, 2023
• Study Completion (Anticipated): January 30, 2023

Study Registration Dates

• First Submitted: November 10, 2022
• First Submitted That Met QC Criteria: November 10, 2022
• First Posted (Actual): November 17, 2022

Study Record Updates

• Last Update Posted (Actual): December 14, 2022
• Last Update Submitted That Met QC Criteria: December 11, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Stomatognathic Diseases; Jaw Diseases; Craniomandibular Disorders; Mandibular Diseases; Myofascial Pain Syndromes; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
• Other Study ID Numbers: TMD_Laser_2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No