Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus Therapeutic Ultrasound On Patients With Myofascial Pain Disorder : A Randomized Clinical Trial

NCT07800338 | Not Yet Recruiting

• 1 other identifier: tmj Myofascial Pain Disorder
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

Myofascial pain dysfunction (MPD) is one of the most common causes of chronic orofacial pain, primarily affecting the masticatory muscles such as the masseter and temporalis. It leads to facial pain, muscle tenderness, and restricted mouth opening, significantly impacting patients' quality of life and daily function. Despite the wide range of conservative treatment modalities-such as medications, splint therapy, and physiotherapy-there is still no universally accepted approach that provides consistent and long-lasting relief. Low-level laser therapy (LLLT) and therapeutic ultrasound (US) are two non-invasive physical modalities frequently used in dentistry for pain control and tissue healing. Each has shown promising outcomes individually. Azizi et al. (2007) demonstrated that LLLT at 780 nm can significantly reduce pain and tenderness for up to three months, while Khairy (2018) reported notable pain relief and improved jaw function using pulsed ultrasound at 1.5 W/cm² for 5 minutes over 10 sessions. However, direct comparative evidence between LLLT and therapeutic ultrasound in patients with myofascial pain dysfunction is still lacking. This knowledge gap prevents clinicians from identifying which modality offers superior short- and long-term outcomes in terms of pain reduction, muscle function improvement, and patient satisfaction. Therefore, this study aims to compare the efficacy of low-level laser therapy versus therapeutic ultrasound in the management of myofascial pain dysfunction, using standardized treatment parameters from the most evidence-based protocols in the literature.

Conditions

TMJ

Outcome Measures

Primary Outcomes (1)

• pain

  pain severity will be assessed using Visual analogue scale 0-10

  measured at baseline ,1week, 2weeks, 3weeks, 4weeks, 1months,3months, 6months

Secondary Outcomes (1)

• Maximum interincisal opening

  baseline , 1week, 2weeks,3weeks, 4weeks, 1month,3months, 6months

Study Arms (2)

Evaluation The Effect Of Low-Level Laser Therapy On Masseter Muscle On Patients With Myofascial Pain

EXPERIMENTAL

Low-Level Laser Therapy (LLLT) utilizes light energy, typically in the red or near-infrared spectrum (630-830 nm), to stimulate photochemical reactions in the target tissues. The absorbed photons enhance mitochondrial activity, increase ATP production, improve local blood circulation, and reduce inflammatory mediators such as prostaglandins and bradykinin. These actions contribute to analgesia, relaxation of muscle fibers, and acceleration of tissue repair. In the study by Azizi et al. (2007), LLLT at 780 nm with a total energy of 1200 mJ per treated region significantly reduced pain and muscle tenderness, and these imp

Device: Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder

Evaluation Of The Effect Of therapeutic Ultrasound On Patients With Myofascial Pain Disorder

EXPERIMENTAL

Therapeutic Ultrasound (US), on the other hand, transmits mechanical acoustic energy through soft tissues, producing micro-vibration and mild thermal effects. These effects increase cellular permeability, stimulate fibroblast activity, enhance microcirculation, and facilitate the resorption of inflammatory exudates. The pulsed mode specifically provides a non-thermal biostimulatory effect, making it suitable for acute or painful conditions. Khairy (2018) reported that pulsed ultrasound at 1.5 W/cm² for 5 minutes per session over ten sessions produced significant reductions in pain intensity and improvement in mouth opening in patients with myofascial pain dysfunction.

Device: Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder

Interventions

Evaluation Of The Effect Of Low-Level Laser Therapy On Masseter Muscle Versus therapeutic Ultrasound On Patients With Myofascial Pain Disorder DEVICE

Given that both modalities promote pain relief and muscle recovery through distinct biological pathways-LLLT via photobiomodulation and US via mechanical and thermal stimulation-a direct comparison between them can determine which produces superior clinical outcomes in terms of pain reduction, functional improvement, and duration of therapeutic effect.

Evaluation Of The Effect Of therapeutic Ultrasound On Patients With Myofascial Pain Disorder; Evaluation The Effect Of Low-Level Laser Therapy On Masseter Muscle On Patients With Myofascial Pain

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients should have one or more signs and symptoms of these
• Symptoms: Patients who report typical symptoms of myofascial pain , such as pain, discomfort, especially when opening or closing the mouth.
• Mouth Opening: Limited range of motion or difficulty with full mouth opening.
• Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck.
• Patients who will be free from any systemic diseases that affect temporomandibular joint.
• Patients who will be ready to give informed consent.

You may not qualify if:

• Blood dyscrasias and systemtic diseases.
• Previous surgery of the affected joint.
• Infection
• Patients with previous facial fracture.
• Patients who will be under another type of treatment for TMD (e.g., occlusal splints, pharmacological drugs, or head and neck surgery).
• Patients who will not attend the proposed treatment sessions or follow-up visits.

Sponsors & Collaborators

• Cairo University: lead

Related Links

• Related Info

Central Study Contacts

mohamed mostafa dentist, bachelor's degree

CONTACT

01060249544; Mohamed-elsebaie@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dentist

Study Record Dates

• First Submitted: August 28, 2026
• First Posted: September 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08