NCT07531654

Brief Summary

The goal of this clinical trial is to evaluate and compare the effectiveness of modified laser therapy versus conventional laser therapy in managing pain and mandibular function in patients with chronic myofascial pain syndrome involving the masseter muscles. The main questions it aims to answer are:

  1. 1.Does high-intensity laser therapy (HILT) provide a greater reduction in pain intensity on a numerical rating scale (NRS) compared to low-level laser therapy (LLLT)?
  2. 2.Does high-intensity laser therapy (HILT) provide greater improvement in functional outcomes, specifically maximal incisal opening, compared to low-level laser therapy (LLLT)?
  3. 3.Be randomly assigned to either the HILT or LLLT treatment group.
  4. 4.Undergo 12 laser irradiation sessions delivered over one month.
  5. 5.Have laser energy applied directly to the trigger points of the masseter muscles during 5-minute sessions.
  6. 6.Attend follow-up assessments at each session, and at intervals of 1, 3, and 6 months.
  7. 7.Provide pain ratings using a numerical scale and have their maximal mouth opening measured by a caliper.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 15, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2026

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2026

Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

7 months

First QC Date

April 9, 2026

Last Update Submit

April 9, 2026

Conditions

Myofascial Pain Dysfunction Syndrome

Outcome Measures

Primary Outcomes (1)

  • Pain Assessment

    Pain will be assessed using a numerical rating scale (NRS) at rest and during mouth opening at the following follow up time points: at each session, 1, 3 months and 6 months.

Secondary Outcomes (1)

  • Maximal incisal opening

    Maximal incisal opening is measured at each session, 1, 3 months and 6 months.

Study Arms (2)

High intensity Laser Therapy (HLLT)

EXPERIMENTAL
Device: High Level Laser Therapy

Low Level Laser Therapy (LLLT)

ACTIVE COMPARATOR
Device: Low Level Laser Therapy

Interventions

Low Level Laser TherapyDEVICE

Laser energy density of 1.5 KJ will be applied to the masseter muscles using an epic-x940 nm diode laser (BioLase, USA), with 12 irradiation sessions delivered over one month. The mode of laser was a continuous wave irradiation for 5 minutes, distance to Tissue\~1 cm, and the area of the laser delivery tip was 5 cm2. The trigger point was identified within the affected muscle.

Low Level Laser Therapy (LLLT)
High Level Laser TherapyDEVICE

Laser energy density of 3 KJ will be applied to the masseter muscles using an epic-x940 nm diode laser, with 12 irradiation sessions delivered over one month. The mode of laser was a continuous wave irradiation for 5 minutes, distance to Tissue\~1 cm, and the area of the laser delivery tip was 5 cm2. The trigger point was identified within the affected muscle.

High intensity Laser Therapy (HLLT)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of myofascial temporomandibular disorder following the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD).
  • No previous laser therapy for last 3 months.
  • Pain localized to the masseter muscles.
  • Pain lasting at least 3 months with a self-reported pain level of 6 or higher on a numerical rating scale (NRS).

You may not qualify if:

  • Patients with TMJ pain, or those who had any previous treatment for TMD 2- Patients with any history of cervical or degenerative conditions, any surgery or trauma to the neck during last year 3- Previous treatment of MPDS during last year 4- Confirmed diagnosis of fibromyalgia or rheumatoid arthritis 5- Patients with dark skin tone or chubby face

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Central Study Contacts

Ayman M Gouda, Phd

CONTACT

+0201006934468ayman.gouda@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor of Oral and Maxillofacial Surgery

Study Record Dates

First Submitted

April 9, 2026

First Posted

April 15, 2026

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 12, 2026

Study Completion (Estimated)

December 12, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Locations

EG(1)