NCT07840495

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of low-level laser therapy (LLLT) as an adjunct treatment in patients aged 18 years and older diagnosed with temporomandibular disorders (TMD). The main questions it aims to answer are:

  1. 1.Does LLLT improve pain intensity during muscle palpation and mandibular movements?
  2. 2.Does LLLT improve functional outcomes, such as maximum mouth opening, lateral excursions, and protrusive movements?

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 2, 2024

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 25, 2026

Completed
Last Updated

October 1, 2026

Status Verified

September 1, 2026

Enrollment Period

1.4 years

First QC Date

September 18, 2026

Last Update Submit

September 27, 2026

Conditions

Low Level Laser TherapyTemporomandibular Joint DisordersPainPhysical Therapy

Keywords

Low level laser therapytemporomandibular joint disorderspainphysical therapy

Outcome Measures

Primary Outcomes (1)

  • Pain: VAS score

    Visual Analogue Scale (VAS): score 0 (no pain) to 10 (maximum pain) during muscle palpation and mandibular movement

    Assessments were conducted at baseline, after each treatment session (S1 - S6) [three times weekly for two weeks], and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.

Secondary Outcomes (5)

  • Maximum pain-free mouth opening

    Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.

  • Maximum mouth opening with pain, unassisted

    Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.

  • d) Maximum assisted mouth opening

    Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.

  • Right and Left lateral movement

    Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.

  • Protrusive mandibular movement

    Assessments were conducted at baseline, after each treatment session (S1 - S6), and at follow-up on Day 14 (D14) and Day 30 (D30) post-treatment.

Study Arms (2)

Patients with TMDs

EXPERIMENTAL

The LLLT group was treated with a 940 nm diode laser (10 J/cm2, 0.3 W, 1.13 cm2 spot size) applied to tender points for 38 seconds per point over six sessions within two weeks

Device: LLLT

Patient with TMDs + Sham treatment

SHAM COMPARATOR

Patients with TMDs and given Sham treatment

Procedure: Sham (No LLLT)

Interventions

LLLTDEVICE

The LLLT group was treated with a 940 nm diode laser (10 J/cm2, 0.3 W, 1.13 cm2 spot size) applied to tender points for 38 seconds per point over six sessions within two weeks

Patients with TMDs
Sham (No LLLT)PROCEDURE

Non activated LLLT applied to tender points for 38 seconds per point over six sessions within two weeks

Patient with TMDs + Sham treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 and above
  • Patients diagnosed with TMD utilizing Axis I of the DC/TMD
  • Patients diagnosed with TMD irrespective of the severity as screened utilizing the Fonseca Anamnestic Index (FAI) questionnaire form (APPENDIX D)
  • American Association of Anesthesiologists (ASA) Physical Status Classification I-II
  • Class I occlusion/malocclusion
  • Natural dentition patient with at least one pair of occluding posterior teeth on each side of the mandible

You may not qualify if:

  • Patients who refuse participation/do not consent to the study
  • Patients presenting with any lesion or pathology over the TMJ region
  • Patients presented with TMD-like signs and symptoms secondary to non-TMJ origin (pain or infection of odontogenic origin, ear origin, neuralgia, migraine, atypical facial pain, etc.)
  • Patients that are presented with active infection involving the orofacial region
  • Patients with psychiatric and neurological disorders as confirmed by medical practitioners.
  • Patients with systemic or autoimmune disorders affecting the masticatory system, bones, and joints (rheumatoid arthritis, osteoarthritis)
  • Patients that are contraindicated for the use of LLLT (malignant disease, ongoing radiotherapy, thyroid gland disease, epilepsy, light sensitivity, hemophilia, and other blood and clotting diseases, etc.)
  • TMD patients receiving physical or psychological treatment, and those who have been using muscle relaxants, anti-inflammatory agents (for at least seven days before study begins) or an occlusal appliance
  • Patients with a history of facial bone fractures
  • Patients on fixed orthodontic appliances, history of orthognathic surgery, or TMJ surgery
  • Patients with occlusal interferences, removable partial or total denture wearers, and fixed prostheses that are affecting patients' occlusion
  • Patients with an allergy to, or contraindication for, the use of NSAIDs
  • Pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Universiti Malaya, Malaysia

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

Location

Related Publications (1)

  • 1. Li DTS, Leung YY. Temporomandibular disorders: current concepts and controversies in diagnosis and management. Diagnostics (Basel). 2021: 11: 459. doi:10.3390/diagnostics11030459 2. Zieliński G, Pająk-Zielińska B, Ginszt M. A meta-analysis of the global prevalence of temporomandibular disorders. J Clin Med. 2024: 13: 665. doi:10.3390/jcm13051365 3. Suvinen TI, Reade PC, Kemppainen P, Könönen M, Dworkin SF. Review of aetiological concepts of temporomandibular pain disorders: towards a biopsychosocial model for integration of physical disorder factors with psychological and psychosocial illness impact factors. Eur J Pain. 2005: 9: 613-633. doi:10.1016/j.ejpain.2005.01.012 4. Taylor DN, Winfield T, Wynd S. Low-level laser light therapy dosage variables vs treatment efficacy of neuromusculoskeletal conditions: a scoping review. J Chiropr Med. 2020: 19: 119-127. doi:10.1016/j.jcm.2020.06.002 5. Carrasco TG, Mazzetto MO, Mazzetto RG, Mestriner WJ. Low intensity laser therapy in temporomandibular disorder: a phase II double-blind study. Cranio. 2008: 26: 274-281. doi:10.1179/crn.2008.037 6. Çetiner S, Kahraman SA, Yücetaş S. Evaluation of low-level laser therapy in the treatment of temporomandibular disorders. Photomed Laser Surg. 2006: 24: 637-641. doi:10.1089/pho.2006.24.637 7. Fikácková H, Dostálová T, Navrátil L, Klaschka J. Effectiveness of low-level laser therapy in temporomandibular joint disorders: a placebo-controlled study. Photomed Laser Surg. 2007: 25: 297-303. doi:10.1089/pho.2007.2053 8. Díaz L, Restelli L, Valencia E, Atalay DI, Abarca JM, Gil AC, et al. Effectiveness of low-level laser therapy on temporomandibular disorders. A systematic review of randomized clinical trials. Photodiagnosis Photodyn Ther. 2025: 53: 104558. doi:10.1016/j.pdpdt.2025.104558 9. Aisaiti A, Zhou Y, Wen Y, Zhou W, Wang C, Zhao J, et al. Effect of photobiomodulation therapy on painful temporomandibular disorders. Sci Rep. 2021: 11: 9049. doi:10.1038/s41598-021-87265-0

    BACKGROUND

MeSH Terms

Conditions

Temporomandibular Joint DisordersPain

Interventions

Low-Level Light Therapysalicylhydroxamic acid

Condition Hierarchy (Ancestors)

Craniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular DiseasesStomatognathic DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Laser TherapyTherapeuticsPhototherapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Recruited patients were randomly assigned into treatment group (LLLT) and placebo (sham) group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Dr

Study Record Dates

First Submitted

September 18, 2026

First Posted

September 25, 2026

Study Start

January 2, 2024

Primary Completion

May 30, 2025

Study Completion

August 30, 2025

Last Updated

October 1, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared to protect participant confidentiality and privacy. The informed consent approved by the Ethics Committee/Institutional Review Board (IRB) did not include explicit authorization from participants for secondary data sharing or broad external repository deposition. Furthermore, due to the granular nature of the clinical data collected, full de-identification cannot be guaranteed without risk of re-identification. Aggregate data, summary statistics, and primary outcomes will instead be made available through peer-reviewed publications.

Locations

MY(1)