Laser Therapy and Temporomandibular Disorders

NCT05620758 | Unknown

• 1 other identifier: TMD_Laser_2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

TMD

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (5)

Nd YAG laser

EXPERIMENTAL

Other: Nd YAG laser

Diode laser 980 nm

EXPERIMENTAL

Other: diode laser (980 nm)

Diode laser 940 nm

EXPERIMENTAL

Other: diode laser (940 nm)

Diode laser 660 nm

EXPERIMENTAL

Other: diode laser (660 nm)

Diode laser 635 nm

EXPERIMENTAL

Other: diode laser (635 nm)

Interventions

Nd YAG laser OTHER

patients from those diagnosed with TMD will receive Nd YAG laser 1064 nm

Nd YAG laser

diode laser (980 nm) OTHER

patients from those diagnosed with TMD will receive a diode laser (980 nm)

Diode laser 980 nm

diode laser (940 nm) OTHER

patients from those diagnosed with TMD will receive a diode laser (940 nm)

Diode laser 940 nm

diode laser (660 nm) OTHER

patients from those diagnosed with TMD will receive a diode laser (660 nm)

Diode laser 660 nm

diode laser (635 nm) OTHER

patients from those diagnosed with TMD will receive a diode laser (635 nm)

Diode laser 635 nm

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hams Hamed Abdelrahman: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

Lasers, Solid-State; Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Nermeen A Rady, phd

CONTACT

01223349577; nermeen.rady@alexu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Study Record Dates

• First Submitted: November 10, 2022
• First Posted: November 17, 2022
• Study Start: November 30, 2022
• Primary Completion: January 30, 2023
• Study Completion: January 30, 2023
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

EG (1)