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.
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
- Conditions the study is for
- Low Level Laser Therapy, Temporomandibular Joint Disorders, Pain
- 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)
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- 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
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
- Does LLLT improve pain intensity during muscle palpation and mandibular movements?
- 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 group | Role | What they receive |
|---|---|---|
| Patients with TMDs | Experimental | 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 Receives: Device: LLLT |
| Patient with TMDs + Sham treatment | Sham comparator | Patients 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.
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)
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.
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.
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.
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.
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.
- First posted25 Sep 2026
- Study start2 Jan 2024
- Primary completion30 May 2025
- Study completion30 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Level Laser TherapyStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Recruited patients were randomly assigned into treatment group (LLLT) and placebo (sham) group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tan Chuey Chuan, University of Malaya
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
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Low-level Laser Therapy (LLLT) as an Adjunct Treatment for Pain and Functional Outcomes in Temporomandibular Disorders (TMD)
- ClinicalTrials.gov ID
- NCT07840495
- Acronym / sponsor ID
- LLLT IN TMD / DF OS2308/0061
- Keywords
- Low level laser therapy, temporomandibular joint disorders, pain, physical therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 2 Jan 2024 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 Aug 2025 (actual)
- First posted
- 25 Sep 2026 (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.
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:
- Does LLLT improve pain intensity during muscle palpation and mandibular movements?
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Recruited patients were randomly assigned into treatment group (LLLT) and placebo (sham) group.
| Arm | Type | Receives |
|---|---|---|
| Patients with TMDs | Experimental | Device: LLLTThe 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 |
| Patient with TMDs + Sham treatment | Sham comparator | Procedure: Sham (No LLLT)Patients with TMDs and given Sham treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| LLLTThe 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 | Device | Patients with TMDs |
| Sham (No LLLT)Non activated LLLT applied to tender points for 38 seconds per point over six sessions within two weeks | Procedure or surgery | Patient with TMDs + Sham treatment |
Primary outcome
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
5 secondary outcomes
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.
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.
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.
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.
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.
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 1 Oct 2026.
- Background1. 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
- Individual participant dataSharing planned: 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.
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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?
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.