Temporomandibular Joint DisordersLASER-SMNCT06419738

Efficacy of Combining Low-Level Laser Therapy With a Self-Management Program on Myalgia in Temporomandibular Disorders

A study testing Self-Management Program, Low level laser therapy combined with Self-Management Program and Occlusal Splint combined with Self-Management Program in people with Temporomandibular Joint Disorders and Facial Pain, run by Hanoi Medical University at 1 site in Vietnam.

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 purpose of this study is to evaluate the efficacy of combining low-level laser therapy and the self-management program for patients with temporomandibular joint disorders using a randomized controlled design. Read more about this study

Who is it for?: Ages 16 years and older
Conditions the study is for: Temporomandibular Joint Disorders, Facial Pain
What is being tested?: Self-Management Program, Low level laser therapy combined with Self-Management Program and Occlusal Splint combined with Self-Management Program
Type of treatment: Medical device, Surgery or procedure, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 1 siteVietnam
Study dates: 14 Mar 2023to 30 Apr 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 16 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patients diagnosed with Temporomandibular joint Disorders (according to DC/TMD) with acute or subacute temporal muscle and/or masseter muscle pain (less than 3 months).
All patients aged 16 years or older, capable of comprehending the doctor's opinion and complying with the examination process.

Who cannot join

Patients with chronic TMDs pain, swelling and pain in the mouth that prevent wearing a occlusal splint.
Patients with history of severe neurological disorders, autoimmune joint and muscle diseases, advanced malignant cancer, history of mental illness, history of alcoholism, drug and painkiller abuse, undergoing surgery and/or radiotherapy on the neck and face, other treatments on the neck and temporomandibular joint within 3 months, use of drugs that may affect the neuromuscular system.
Pregnant patients

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

High-tech center for Ondonto-stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University
Hà Nội, 11300

Other trials in Vietnam

About this study

Official title: Clinical, Psychosocial, Behavioral Characteristics and Treatment Effectiveness of Low Level Laser Therapy on Patients With Temporomandibular Joint Disorders

Read the detailed description

The purpose of this study is to evaluate the efficacy of combining low level laser therapy and self-management program for patients with temporomandibular joint disorders using a randomized controlled design.

66 patients suffering from acute and subacute myalgia diagnosed using Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) at High-tech Center for Odonto-Stomatology, Institute of Odonto-Stomatology, Ha Noi Medical University, Viet Nam. Patients without treatment (because of economic or geographical conditions) were persuaded to join the control group. Group 3 includes 22 patients who will be counseled on changing habits, adjusting behavior, exercising and will be taken in order of examination. 44 patients will be randomized into the remaining 2 groups:

Group 1: wear stabilization splint at night for 2 months combined with counseling, behavior modification, and exercise.
Group 2: recieve low level laser treatment 3 times aweek, 20 seconds/ session, 10 sessions in total, combined with counseling, behavior modification, and exercise.

Assessment takes place at baseline, after treatment approximately 2 weeks, 4 weeks, 12 weeks, 24 weeks later and 48 weeks follow up. The effects of the interventions are evaluated in terms of reduction in pain intensity (Visual Analogue Scale-VAS), number of masticatory muscle pain point with palpation, number of supplemental muscle pain with palpation, maximum mouth opening, right lateral movements, left lateral movements, protrusive movements, Jaw functional limitation scale (JFLS-8), psychological variables such as PHQ-9, PHQ-4, GAD-7.

Data were entered and analyzed by SPSS 16.0 software. Use Mann-Whitney U test, Kruskal-Wallis test, and Wilcoxon test applied to non-normally distributed variables to compare VAS between groups at different follow-up times. Use paired t-test and independent t-test to compare the maximum opening, lateral movements, protrusive movements, JFLS-8, PHQ-9, PHQ-4, GAD-7 between groups before and after treatment. p value < 0.05 is considered statistically significant.

Conditions: Temporomandibular Joint Disorders, Facial Pain
Being tested: Self-Management Program, Low level laser therapy combined with Self-Management Program, Occlusal Splint combined with Self-Management Program
Keywords: temporomandibular joint disorders, temporomandibular disorders, low-level laser therapy, temporomandibular disorders treatment, temporomandibular joint disorders, temporomandibular disorders, low-level laser therapy, self - management program, occlusal splint, Treatment of temporomandibular disorders
Medical subject headings: Temporomandibular Joint Disorders, Facial Pain

What participants receive

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

Self-Management ProgramBehavioural
Self-Management Program includes education about the disorder, proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses.
Low level laser therapy combined with Self-Management ProgramRadiation
LLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shined on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed Self-Management Program as group 1.
Occlusal Splint combined with Self-Management ProgramDevice
Maxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks.In addition, patients are still instructed Self-Management Program as group 1.

Study groups in NCT06419738
Study group	Role	What they receive
Self-Management Program	Active comparator	Self-Management Program includes education about the disorder, proprioceptive awareness, and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses. Receives: Behavioral: Self-Management Program
Low level laser therapy combined with Self-Management Program	Experimental	LLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shone on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed Self-Management Program as group 1. Receives: Behavioral: Self-Management Program; Radiation: Low level laser therapy combined with Self-Management Program
Occlusal Splint combined with Self-Management Program	Active comparator	Maxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks. In addition, patients are still instructed Self-Management Program as group 1. Receives: Behavioral: Self-Management Program; Device: Occlusal Splint combined with Self-Management Program

What is being measured

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

VAS
The VAS (Visual Analog Scale) pain scale consists of a 10 cm long straight line (without marks), with "no pain" written at the left end and "unbearable pain" written at the right end. Patients were instructed to mark a vertical line above the horizontal line indicating the intensity of their pain. The distance from the zero point to the marker is then measured in millimeters by a caliper. Add the total score of the answers to evaluate the severity according to the following scale: ≤3.4: mild; 3.5-7.4: average; ≥ 7.5: severe
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Numbers of masticatory muscle pain with palpation
Numbers of muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Maximum mouth opening
Maximum mouth opening (MMO) was defined asthe maximal interincisal distance on unassisted active mouth opening when the patient opens his mouth maximally without feeling pain. Use a ruler with mm value.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Numbers of supplemental muscle pain with palpation
Numbers of supplemental muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

Secondary outcomes (7)

Right lateral movements
Ask the patient to open slightly, and to move his or her jaw as far as he/she can to the right, even if it is painful. Measure from the maxillary reference midline to the mandibular reference midline.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Left lateral movements
Ask the patient to open slightly, and to move his or her jaw as far as he/she can to the left, even if it is painful. Measure from the maxillary reference midline to the mandibular reference midline.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Protrusive movements
Ask the patient to open slightly, and to move his or her jaw as far as he/she can forward, even if it is painful. Measure the distance from the buccal surface of the mandibular tooth to the buccal surface of the maxillary tooth.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
JFLS-8
JFLS-8 (Jaw Functional Limitation Scale - 8) according to DC/TMD axis II to evaluate the level of mandibular function limitation in the past 30 days. The patient will be instructed to answer the questionnaire: in case the patient avoids the activity completely because it is too difficult to do, the patient will circle '10'. If the patient avoids an activity not for pain or difficulty, he/ she will leave this section blank. Activities include: chewing hard foods, chewing chicken, eating soft foods without chewing, opening mouth wide enough to drink from a cup, swallowing, yawning, speaking, laughing.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
GAD-7
General anxiety symptoms were assessed using the 7-item scale from the Patient Health Questionnaire (GAD-7). The GAD-7 asks for anxiety symptoms during the past month on a 1 ('not at all') to 3 ('more than half of the days') rating scale (range 7-21). Higher scores indicate higher levels of anxiety.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
PHQ-9
Patient Health Questionnaire-9 is a depression assessment form. Patients answer questions consisting of 9 items. Responses will be scored as follows: none: 0 points; several days: 1 point; more than half of the days of the week: 2 points; almost every day: 3 points. Add the total score of the answers to evaluate the severity according to the following scale: 0-4 points: normal; 5-9 points: mild; 10-14 points: average; 15-19 points: quite severe; 20-27 points: severe.
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
OBC
Oral behaviors checklist (OBC) is to determine the presence of parafunctional behaviors. The score is calculated by summing the validation scores of the corresponding items. Response options are scored 0-4 for each item. Based on a comparison of people with chronic TMDs to people without TMDs, scores of 0-16 are normal, while scores of 17-24 occur twice as often in people with TMDs, and scores of 25-62 occur 17 times more often. Acting as a risk factor for TMDs, a score between 25-62 contributes to the onset of TMDs
Measured: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

Timeline

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

14 Mar 202330 Apr 2025

First posted17 May 2024
Study start14 Mar 2023
Primary completion30 Apr 2025
Study completion30 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Temporomandibular Joint DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 66 patients were divided into 3 groups.Patients without treatment (because of economic or geographical conditions) were persuaded to join the control group. Group 3 includes 22 patients who will be counseled on changing habits, adjusting behavior, exercising and will be taken in order of examination. 44 patients will be randomized into the remaining 2 groups by using Excel software to create a random number table, patients will draw even numbers into group 2, odd numbers into group 1. * Group 1: wear stabilization splint at night for 2 months combined with counseling, behavior modification, and exercise. * Group 2: recieve low level laser treatment 3 times aweek, 20 seconds each time, 10 times in total, combined with counseling, behavior modification, and exercise.
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06419738
Sponsor's protocol ID: NCS01050122107
Acronym: LASER-SM
Status last verified: Jan 2026
First submitted: 14 May 2024
Last updated: 27 Jan 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: Investigators have no plans to publish data related to research participants because all patients included in the doctoral training project of Hanoi Medical University have signed a commitment not to disclose information about the patients in the Ethics Committee's Consent to Participate.

Publications

Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15.
PubMed 23318917
Ahmad SA, Hasan S, Saeed S, Khan A, Khan M. Low-level laser therapy in temporomandibular joint disorders: a systematic review. J Med Life. 2021 Mar-Apr;14(2):148-164. doi: 10.25122/jml-2020-0169.
PubMed 34104237
Xu GZ, Jia J, Jin L, Li JH, Wang ZY, Cao DY. Low-Level Laser Therapy for Temporomandibular Disorders: A Systematic Review with Meta-Analysis. Pain Res Manag. 2018 May 10;2018:4230583. doi: 10.1155/2018/4230583. eCollection 2018.
PubMed 29861802
Ayyildiz S, Emir F, Sahin C. Evaluation of Low-Level Laser Therapy in TMD Patients. Case Rep Dent. 2015;2015:424213. doi: 10.1155/2015/424213. Epub 2015 Oct 26.
PubMed 26587294
Desai AP, Roy SK, Semi RS, Balasundaram T. Efficacy of Low-Level Laser Therapy in Management of Temporomandibular Joint Pain: A Double Blind and Placebo Controlled Trial. J Maxillofac Oral Surg. 2022 Sep;21(3):948-956. doi: 10.1007/s12663-021-01591-4. Epub 2021 May 25.
PubMed 36274894
Basili M, Barlattani A Jr, Venditti A, Bollero P. Low-level laser therapy in the treatment of muscle-skelet pain in patients affected by temporo-mandibular disorders. Oral Implantol (Rome). 2017 Jan 21;10(4):406-411. doi: 10.11138/orl/2017.10.4.406. eCollection 2017 Oct-Dec.
PubMed 29682258
Farshidfar N, Farzinnia G, Samiraninezhad N, Assar S, Firoozi P, Rezazadeh F, Hakimiha N. The Effect of Photobiomodulation on Temporomandibular Pain and Functions in Patients With Temporomandibular Disorders: An Updated Systematic Review of the Current Randomized Controlled Trials. J Lasers Med Sci. 2023 Aug 5;14:e24. doi: 10.34172/jlms.2023.24. eCollection 2023.
PubMed 37744015
Demirkol N, Sari F, Bulbul M, Demirkol M, Simsek I, Usumez A. Effectiveness of occlusal splints and low-level laser therapy on myofascial pain. Lasers Med Sci. 2015 Apr;30(3):1007-12. doi: 10.1007/s10103-014-1522-7. Epub 2014 Feb 7.
PubMed 24504660
Hoa NN, Do T, Hoang VH, Thanh Dong T, Quyen TTM, Binh TT. Photobiomodulation versus stabilization splint, both combined with self-management, for acute temporomandibular myalgia: 48-week outcomes of a partially randomized controlled study. PLoS One. 2026 Oct 27;21(10):e0360472. doi: 10.1371/journal.pone.0360472. eCollection 2026.
PubMed 42945268

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder

All Temporomandibular Joint Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical, Psychosocial, Behavioral Characteristics and Treatment Effectiveness of Low Level Laser Therapy on Patients With Temporomandibular Joint Disorders
ClinicalTrials.gov ID: NCT06419738
Acronym / sponsor ID: LASER-SM / NCS01050122107
Conditions: Temporomandibular Joint Disorders, Facial Pain
Keywords: temporomandibular joint disorders, temporomandibular disorders, low-level laser therapy, temporomandibular disorders treatment, temporomandibular joint disorders, temporomandibular disorders, low-level laser therapy, self - management program, occlusal splint, Treatment of temporomandibular disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Hanoi Medical UniversityUniversity, hospital or other
Study start: 14 Mar 2023 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 30 Apr 2025 (actual)
First posted: 17 May 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Group 1: wear stabilization splint at night for 2 months combined with counseling, behavior modification, and exercise.
Group 2: recieve low level laser treatment 3 times aweek, 20 seconds/ session, 10 sessions in total, combined with counseling, behavior modification, and exercise.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: 66 patients were divided into 3 groups.Patients without treatment (because of economic or geographical conditions) were persuaded to join the control group. Group 3 includes 22 patients who will be counseled on changing habits, adjusting behavior, exercising and will be taken in order of examination. 44 patients will be randomized into the remaining 2 groups by using Excel software to create a random number table, patients will draw even numbers into group 2, odd numbers into group 1. * Group 1: wear stabilization splint at night for 2 months combined with counseling, behavior modification, and exercise. * Group 2: recieve low level laser treatment 3 times aweek, 20 seconds each time, 10 times in total, combined with counseling, behavior modification, and exercise.

Arm	Type	Receives
Self-Management Program	Active comparator	Behavioral: Self-Management ProgramSelf-Management Program includes education about the disorder, proprioceptive awareness, and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses.
Low level laser therapy combined with Self-Management Program	Experimental	Behavioral: Self-Management Program, Radiation: Low level laser therapy combined with Self-Management ProgramLLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shone on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed Self-Management Program as group 1.
Occlusal Splint combined with Self-Management Program	Active comparator	Behavioral: Self-Management Program, Device: Occlusal Splint combined with Self-Management ProgramMaxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks. In addition, patients are still instructed Self-Management Program as group 1.

Who may qualify

Ages: 16 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Patients diagnosed with Temporomandibular joint Disorders (according to DC/TMD) with acute or subacute temporal muscle and/or masseter muscle pain (less than 3 months).
All patients aged 16 years or older, capable of comprehending the doctor's opinion and complying with the examination process.

Key exclusion criteria (3 listed)

Patients with chronic TMDs pain, swelling and pain in the mouth that prevent wearing a occlusal splint.
Patients with history of severe neurological disorders, autoimmune joint and muscle diseases, advanced malignant cancer, history of mental illness, history of alcoholism, drug and painkiller abuse, undergoing surgery and/or radiotherapy on the neck and face, other treatments on the neck and temporomandibular joint within 3 months, use of drugs that may affect the neuromuscular system.
Pregnant patients

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Self-Management ProgramSelf-Management Program includes education about the disorder, proprioceptive awareness and reversing parafunctional habits, relaxation techniques, and stress management. Furthermore, patients are also consulted on changing habits, adjusting behavior, and exercising. Patients are instructed to adjust their behavior: quit harmful habits to limit pain in daily functional activities, maintain scientific sleep, maintain good head, neck, and shoulder activities, soft diet and avoid hard foods, do exercises twice a day: open mouth wide combined with cool compresses and warm compresses.	Behavioural	Low level laser therapy combined with Self-Management Program, Occlusal Splint combined with Self-Management Program, Self-Management Program
Low level laser therapy combined with Self-Management ProgramLLLT may facilitate the release of endogenous opioids, tissue repairment and cellular respiration, increase vasodilatation and pain threshold, and decrease inflammation. Diode low-energy laser machine (Sirolaser blue, Dentsply) are set the default mode according to the correct parameters before use: wavelength 660nm, energy level 2.5 J/cm2, power source 100mW. The projection head is placed perpendicular to the muscle being projected. The laser light is shined on the pain point at the beginning of the treatment, then it will shine on muscle points in turn: temporal muscle (anterior, middle, posterior), masseter muscle (upper, middle, lower), 5 points around the temporomandibular joint area (superior, anterior, lateral, posterior, posterior subcondylar). Each masticatory muscle area is treated for 20 seconds, 3 sessions /week (different days), 10 sessions total. In addition, patients are still instructed Self-Management Program as group 1.	Radiation	Low level laser therapy combined with Self-Management Program
Occlusal Splint combined with Self-Management ProgramMaxillary occlusal splints are made of hard acrylic after taking impressions of the upper dental arches, recording of centric relation (Okeson). Splints are adjusted to provide even occlusal contact during jaw closing and chewing, and canine and incisor contact during protrusive movements of the jaw. Patients are instructed to use the splint each night at least 8 hours/day for a period of 8 weeks.In addition, patients are still instructed Self-Management Program as group 1.	Device	Occlusal Splint combined with Self-Management Program

Primary outcome

VAS
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
The VAS (Visual Analog Scale) pain scale consists of a 10 cm long straight line (without marks), with "no pain" written at the left end and "unbearable pain" written at the right end. Patients were instructed to mark a vertical line above the horizontal line indicating the intensity of their pain. The distance from the zero point to the marker is then measured in millimeters by a caliper. Add the total score of the answers to evaluate the severity according to the following scale: ≤3.4: mild; 3.5-7.4: average; ≥ 7.5: severe
Numbers of masticatory muscle pain with palpation
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Numbers of muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one.
Maximum mouth opening
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Maximum mouth opening (MMO) was defined asthe maximal interincisal distance on unassisted active mouth opening when the patient opens his mouth maximally without feeling pain. Use a ruler with mm value.
Numbers of supplemental muscle pain with palpation
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Numbers of supplemental muscle pain points are determined by the examiner using a fingertip force of 1kg to palpate the masticatory muscles: temporal muscles (anterior, middle, posterior), masseter muscles (origin, body, attachment, surrounding muscles. Before palpating , the fingertip force needs to be calibrated 3 times with a micro scale, touching each side one by one.

7 secondary outcomes

Right lateral movements
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Left lateral movements
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
Protrusive movements
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
JFLS-8
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
GAD-7
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
PHQ-9
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.
OBC
Time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
Results publication: PubMed 23318917Ahrari F, Madani AS, Ghafouri ZS, Tuner J. The efficacy of low-level laser therapy for the treatment of myogenous temporomandibular joint disorder. Lasers Med Sci. 2014 Mar;29(2):551-7. doi: 10.1007/s10103-012-1253-6. Epub 2013 Jan 15.
Results publication: PubMed 34104237Ahmad SA, Hasan S, Saeed S, Khan A, Khan M. Low-level laser therapy in temporomandibular joint disorders: a systematic review. J Med Life. 2021 Mar-Apr;14(2):148-164. doi: 10.25122/jml-2020-0169.
Results publication: PubMed 29861802Xu GZ, Jia J, Jin L, Li JH, Wang ZY, Cao DY. Low-Level Laser Therapy for Temporomandibular Disorders: A Systematic Review with Meta-Analysis. Pain Res Manag. 2018 May 10;2018:4230583. doi: 10.1155/2018/4230583. eCollection 2018.
Results publication: PubMed 26587294Ayyildiz S, Emir F, Sahin C. Evaluation of Low-Level Laser Therapy in TMD Patients. Case Rep Dent. 2015;2015:424213. doi: 10.1155/2015/424213. Epub 2015 Oct 26.
Results publication: PubMed 36274894Desai AP, Roy SK, Semi RS, Balasundaram T. Efficacy of Low-Level Laser Therapy in Management of Temporomandibular Joint Pain: A Double Blind and Placebo Controlled Trial. J Maxillofac Oral Surg. 2022 Sep;21(3):948-956. doi: 10.1007/s12663-021-01591-4. Epub 2021 May 25.
Results publication: PubMed 29682258Basili M, Barlattani A Jr, Venditti A, Bollero P. Low-level laser therapy in the treatment of muscle-skelet pain in patients affected by temporo-mandibular disorders. Oral Implantol (Rome). 2017 Jan 21;10(4):406-411. doi: 10.11138/orl/2017.10.4.406. eCollection 2017 Oct-Dec.
Results publication: PubMed 37744015Farshidfar N, Farzinnia G, Samiraninezhad N, Assar S, Firoozi P, Rezazadeh F, Hakimiha N. The Effect of Photobiomodulation on Temporomandibular Pain and Functions in Patients With Temporomandibular Disorders: An Updated Systematic Review of the Current Randomized Controlled Trials. J Lasers Med Sci. 2023 Aug 5;14:e24. doi: 10.34172/jlms.2023.24. eCollection 2023.
Results publication: PubMed 24504660Demirkol N, Sari F, Bulbul M, Demirkol M, Simsek I, Usumez A. Effectiveness of occlusal splints and low-level laser therapy on myofascial pain. Lasers Med Sci. 2015 Apr;30(3):1007-12. doi: 10.1007/s10103-014-1522-7. Epub 2014 Feb 7.
Derived from this study: PubMed 42945268Hoa NN, Do T, Hoang VH, Thanh Dong T, Quyen TTM, Binh TT. Photobiomodulation versus stabilization splint, both combined with self-management, for acute temporomandibular myalgia: 48-week outcomes of a partially randomized controlled study. PLoS One. 2026 Oct 27;21(10):e0360472. doi: 10.1371/journal.pone.0360472. eCollection 2026.
Efficacy of Low-Level Laser Therapy in Management of Temporomandibular Joint Pain: A Double Blind and Placebo Controlled TrialLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. Investigators have no plans to publish data related to research participants because all patients included in the doctoral training project of Hanoi Medical University have signed a commitment not to disclose information about the patients in the Ethics Committee's Consent to Participate.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 3 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 27 Jan 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 Vietnam. 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. 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?

VAS (time frame: Repeated-measures design with six assessment time points: baseline (pre-treatment), and follow-ups at 2, 4, 12, 24, and 48 weeks.). The study lists 4 primary outcomes in all. 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 NCT06419738, which also lists 9 linked publications.

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 27 Jan 2026.