NCT07378462

A Retrospective Randomized Controlled Study Comparing the Effectiveness of Low-level Laser Therapy and Ultrasound Therapy in Reducing Pain and Increasing Maximum Mouth Opening in Forty-six Patients With Temporomandibular Disorders

Completed NA Last updated 30 January 2026

What this trial tests

NA trial testing Low-Level Laser Therapy in Temporomandibular Disorders (TMD) in 46 participants. Completed in 20 November 2024.

Timeline

21 July 2023

Primary endpoint
17 May 2024

20 November 2024

Quick facts

Lead sponsor	B.P. Koirala Institute of Health Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	21 July 2023
Primary completion	17 May 2024
Estimated completion	20 November 2024
Sites	1 location across Nepal

Drugs / interventions tested

• Low-Level Laser Therapy
• Ultrasound therapy

Conditions studied

• Temporomandibular Disorders (TMD) — all drugs for Temporomandibular Disorders (TMD) →
• Temporomandibular Joint Disorder — all drugs for Temporomandibular Joint Disorder →

Sponsor

B.P. Koirala Institute of Health Sciences

Who can join

18 and older, any sex, with Temporomandibular Disorders (TMD) or Temporomandibular Joint Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Temporomandibular disorders (TMDs) are the most common cause of non-dental orofacial pain, involving the temporomandibular joint (TMJ), masticatory muscles, or associated structures. Globally, TMD is the second most prevalent musculoskeletal pain condition after low back pain. Epidemiological data show a high prevalence of TMD symptoms, particularly among women and Asian populations, with significant disease burden reported in Nepal. Conservative management remains the mainstay of TMD treatment, as evidence supporting surgical intervention is limited and inconclusive.

Among conservative modalities, physical therapies such as ultrasound therapy and low-level laser therapy (LLLT) have gained attention for pain reduction and functional improvement. Ultrasound therapy produces thermal and non-thermal effects that enhance blood flow, reduce muscle spasm, improve tissue extensibility, and promote healing. LLLT, through photobiomodulation, acts at the cellular level by increasing ATP production, reducing inflammatory mediators, enhancing collagen synthesis, and providing analgesic and anti-inflammatory effects.

Although several international studies have evaluated ultrasound and LLLT individually or in combination, limited studies have directly compared their effectiveness in TMD, and no such studies have been conducted in Nepal. Therefore, this study aims to compare the effectiveness of therapeutic ultrasound and LLLT in reducing pain and improving mouth opening in patients with TMD presenting to BPKIHS.

This was a retrospective randomized controlled study conducted at the Department of Oral Medicine and Radiology, College of Dental Surgery, BPKIHS. A total of 46 patients diagnosed with myalgia of masticatory muscles and/or TMJ arthralgia according to DC/TMD criteria were included using purposive sampling. Patients were allocated into two groups: Group A received low-level laser therapy (650 nm wavelength, 2 J/cm² for 3 minutes) and Group B received therapeutic ultrasound (1 MHz, 1.3 W/cm², continuous mode for 5 minutes). Five treatment sessions had been administered over two weeks.

Pain intensity was assessed using the Visual Analogue Scale (VAS) at each visit, while inter-incisal mouth opening was measured using a metallic scale at baseline and at the final visit.

Primary outcome measure was the difference in VAS scores in patients undergoing ultrasound therapy and low-level laser therapy for temporomandibular disorder before and after therapy.

Secondary outcome measures included the difference in inter-incisal mouth opening before and after therapy and the effectiveness of ultrasound therapy and low-level laser therapy in reducing pain in patients with arthralgia and myalgia.

Data were analyzed using SPSS version 11.5. Descriptive statistics were calculated, and inferential tests including independent and paired t-tests (or non-parametric equivalents), ANOVA/Kruskal-Wallis tests, and logistic regression were applied where appropriate. Ethical clearance was obtained from the Institutional Review Committee, BPKIHS with Ref. 20/080/081-IRC, Code no. IRC/2509/023.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.