Efficacy of Photobiomodulation Therapy Using 980nm Versus 635nm Diode Lasers for Treatment of Myofascial Pain

NCT07069764 | Completed Results

• 2 other identifiers: NILES-TMD-LLLT-2024TMD-NILES-STUDY-LASER-TRIAL-20
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized controlled clinical trial aims to evaluate the efficacy of low-level laser therapy (LLLT) using two different diode laser wavelengths (980 nm and 635 nm) in the treatment of myofascial pain associated with temporomandibular disorders (TMD). The study compares pain reduction and muscle activity improvement using surface electromyography (sEMG) before and after laser application. Participants are randomly assigned to receive either 980 nm or 635 nm laser treatment twice per week for five weeks. The primary outcomes include pain intensity and functional mandibular movements, while secondary outcomes assess changes in sEMG recordings.

Conditions

Myofascial Pain Syndrome

Keywords

Low-Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• Pain Intensity Reduction

  "Pain intensity was assessed in patients with myofascial pain syndrome of the temporomandibular joint using the Visual Analog Scale (VAS), a 10-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate greater pain intensity. Measurements were recorded at baseline, after 10 sessions of low-level laser therapy (5 weeks), and at 1-month follow-up. Data are reported in the tables below. Lower scores reflect reduced pain intensity

  At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).

Secondary Outcomes (4)

• Maximum Mouth Opening (MMO)

  At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).

• Lateral Jaw Movements

  At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).

• Changes in Muscle Activity Measured by Surface Electromyography (sEMG)

  At baseline and after 10 treatment sessions (5 weeks)

• Protrusive Movements

  At baseline, after 10 treatment sessions (5 weeks), and at 1-month follow-up (approximately 2 months in total from baseline).

Study Arms (2)

Low-Level Laser Therapy at 635 nm for Arm 1

EXPERIMENTAL

Participants will receive low-level laser therapy using a diode laser with 635 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.

Device: Doctor smile 635nm For Arm 1

Low-Level Laser Therapy at 980 nm for Arm 2

EXPERIMENTAL

Participants will receive low-level laser therapy using a diode laser with 980 nm wavelength, applied 2 times per week for 5 weeks to treat myofascial pain syndrome in the temporomandibular joint.

Device: Doctor smile 980 nm For Arm2

Interventions

Doctor smile 635nm For Arm 1 DEVICE

Participants will receive low-level laser therapy using a diode laser with a wavelength of 635 nanometers. The treatment will be applied twice weekly for five weeks to the affected temporomandibular joint muscles to reduce myofascial pain and improve muscle function.

Also known as: device_LLLT

Low-Level Laser Therapy at 635 nm for Arm 1

Doctor smile 980 nm For Arm2 DEVICE

Participants will receive low-level laser therapy using a diode laser with a wavelength of 980 nanometers. The treatment will be applied twice weekly for five weeks to the affected temporomandibular joint muscles to reduce myofascial pain and improve muscle function.

Also known as: device _LLLT

Low-Level Laser Therapy at 980 nm for Arm 2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: "Eligible for both male and female participants
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- patients with myofascial pain due to stress, medically free, not to resort to self-medication during the study period with no chronic diseases.

You may not qualify if:

• Patients with TMJ disorders either due to bony degeneration changes or soft tissue changes.
• Patients with pain of dental etiology were excluded, pregnancy, lactation, cardiac arrhythmia, diabetic patients, erosions and medically free.
• Patient with history of malignancy or a history of previous surgery of neck and/ shoulder within the past year of the study were excluded.
• Any patients had treatment that can affect muscles will be excluded, either pharmacological treatment (e.g, opioids, morphine, muscles relaxants or anti-depressants), physiotherapy management and occlusal splints.

Sponsors & Collaborators

• National Institute of Laser Enhanced Sciences: lead

Study Sites (1)

National Institute for Laser Enhanced Sciences

Cairo, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: DR.hala shaaban attiyah
• Organization: National Institute of Laser Enhanced Sciences (NILES), Cairo University

std.halashaaban@niles.edu.eg

01012894478

Study Officials

• hala SH Attiyah, BDS

  National Institute of Laser Enhanced Sciences (NILES), Cairo University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: "This is an open-label study with no masking; both participants and investigators are aware of the treatment assignments."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist

Model Details: "Randomized controlled trial with two parallel groups comparing the effect of low-level diode laser therapy at 980 nm and 635 nm wavelengths on myofascial pain in temporomandibular disorders. Participants receive treatment sessions over a defined period with outcomes measured by surface electromyography and pain scales."

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: July 17, 2025
• Study Start: August 1, 2024
• Primary Completion: March 29, 2025
• Study Completion: April 29, 2025
• Last Updated: October 23, 2025
• Results First Posted: October 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)