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Completed

NCT Number: NCT07840495

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

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. 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.

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Key information

Conditions

Low Level Laser Therapy Craniomandibular Disorders Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Physical Therapy Signs and Symptoms Stomatognathic Diseases Temporomandibular Joint Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Universiti Malaya, Malaysia

Kuala Lumpur, 50603, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

LLLT

Device

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

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

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Maximum pain-free mouth opening

    Time frame: 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.

    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

  2. Maximum mouth opening with pain, unassisted

    Time frame: 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.

    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.

  3. d) Maximum assisted mouth opening

    Time frame: 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.

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

  4. Right and Left lateral movement

    Time frame: 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.

    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.

  5. Protrusive mandibular movement

    Time frame: 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.

    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

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Acronym: LLLT IN TMD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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