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

University of Malaya30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients aged 18 and above 2. Patients diagnosed with TMD utilizing Axis I of the DC/TMD 3. Patients diagnosed with TMD irrespective of the severity as screened utilizing the Fonseca Anamnestic Index (FAI) questionnaire form (APPENDIX D) 4. American Association of Anesthesiologists (ASA) Physical Status Classification I-II 5. Class I occlusion/malocclusion 6. Natural dentition patient with at least one pair of occluding posterior teeth on each side of the mandible Exclusion Criteria: 1. Patients who refuse participation/do not consent to the study 2. Patients presenting with any lesion or pathology over the TMJ region 3. 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.) 4. Patients that are presented with active infection involving the orofacial region 5. Patients with psychiatric and neurological disorders as confirmed by medical practitioners. 6. Patients with systemic or autoimmune disorders affecting the masticatory system, bones, and joints (rheumatoid arthritis, osteoarthritis) 7. 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.) 8. 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 9. Patients with a history of facial bone fractures 10. Patients on fixed orthodontic appliances, history of orthognathic surgery, or TMJ surgery 11. Patients with occlusal interferences, removable partial or total denture wearers, and fixed prostheses that are affecting patients' occlusion 12. Patients with an allergy to, or contraindication for, the use of NSAIDs 13. Pregnant patients

Outcomes

Primary Outcomes

Pain: VAS score

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

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.

Secondary Outcomes

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