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Low Level Laser TherapyLLLT IN TMDNCT07840495

The Efficacy of Low-level Laser Therapy (LLLT) as an Adjunct Treatment for Pain and Functional Outcomes in Temporomandibular Disorders (TMD)

A study testing LLLT in people with Low Level Laser Therapy and Temporomandibular Joint Disorders, run by University of Malaya at 1 site in Malaysia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
LLLT
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteMalaysia
Study dates
2 Jan 2024to 30 Aug 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Malaysia1 site
  • Faculty of Dentistry, Universiti Malaya, Malaysia

    Kuala Lumpur, Kuala Lumpur, 50603

Other trials in Malaysia

About this study

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:

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

Researchers will compare active LLLT alongside conservative treatment to a sham laser with conservative treatment to see if the active laser provides significantly greater reductions in pain and improvements in jaw function.

Participants will follow a standardized conservative treatment protocol, which includes taking ibuprofen and muscle relaxants, applying moist heat therapy, and eating a soft diet. Receive either an active laser treatment or a sham (placebo) laser treatment on identified tender points for 38 seconds per point, given in six sessions over two weeks. Undergo pain and functional assessments at baseline, after each treatment session, and at Day 14 and Day 30 follow-up visits.

Read the detailed description

This randomized controlled trial included 30 patients diagnosed with TMD based on Axis I of the DC/ TMD criteria. Participants were allocated into two groups: 15 received LLLT alongside conservative treatment, while 15 received sham laser with conservative treatment. Pain was evaluated using the Visual Analogue Scale (VAS) during palpation and mandibular movement, while function was evaluated by measuring mouth opening, lateral excursions and protrusion. 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. The placebo group received sham laser application. Assessments were conducted at baseline, after each session and at Day 14 and Day 30 follow-ups.

Being tested
LLLT, Sham (No LLLT)
Keywords
Low level laser therapy, temporomandibular joint disorders, pain, physical therapy
Medical subject headings
Temporomandibular Joint Disorders, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

  • Sham (No LLLT)Procedure or surgery

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

Study groups in NCT07840495
Study groupRoleWhat they receive
Patients with TMDsExperimentalThe 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
Receives: Device: LLLT
Patient with TMDs + Sham treatmentSham comparatorPatients with TMDs and given Sham treatment
Receives: Procedure: Sham (No LLLT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain: VAS score

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

    Measured: 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)
  1. Maximum pain-free mouth opening

    It is the measurement of the interincisal distance between the maxillary and mandibular reference teeth of the maximum mouth opening of the patient in millimeters - performed either without pain or, if the patient is already in pain, as wide as possible, without worsening the existing pain

    Measured: 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.

  2. Maximum mouth opening with pain, unassisted

    It is the measurement of the interincisal distance between the maxillary and mandibular reference teeth with the patient opening their mouth as wide as possible, even if it causes pain.

    Measured: 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.

  3. d) Maximum assisted mouth opening

    The maximum assisted mouth opening is then measured in millimeters as the interincisal distance between the upper and lower central incisors at this point.

    Measured: 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.

  4. Right and Left lateral movement

    The patient is asked to slightly open their mouth and move the jaw as far to the right as possible, even if it causes pain. The distance, in millimeters, between the maxillary and mandibular midline reference points is recorded as the right lateral movement. Then repeat on the left side.

    Measured: 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.

  5. Protrusive mandibular movement

    The patient is instructed to slightly open their mouth and move the jaw forward as far as possible, even if it causes pain. The measurement, in millimeters, is taken from the buccal surface of a mandibular tooth to the corresponding buccal surface of a maxillary tooth

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2026
  2. Study start2 Jan 2024
  3. Primary completion30 May 2025
  4. Study completion30 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Recruited patients were randomly assigned into treatment group (LLLT) and placebo (sham) group.
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07840495
Sponsor's protocol ID
DF OS2308/0061
Acronym
LLLT IN TMD
Status last verified
Sep 2026
First submitted
18 Sep 2026
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Publications

  • 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

Questions about this trial

What is this clinical trial studying?

A study testing LLLT in people with Low Level Laser Therapy and Temporomandibular Joint Disorders, run by University of Malaya at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain: VAS score (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07840495, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.

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