TMJ PainNCT06068959
Photobiomodulation on Pain in Patients With Temporomandibular Dysfunction
A study testing Photobiomodulation using LED in people with TMJ Pain, run by University of Nove de Julho at 1 site in Brazil.
Trial summary
These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- TMJ Pain
- What is being tested?
- Photobiomodulation using LED
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Feb 2024to 10 Aug 2024
- 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 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- present TMD according Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I
- have all permanent teeth
Who cannot join
- be undergoing orthodontic treatment
- be undergoing other treatment for TMD
- present dental caries or gingival disease.
- Initiate or use any type of medication during the phases of the study
- comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Photobiomodulation With LED Cluster on Pain and Mandibular and Cervical Mobility in Patients With Temporomandibular Dysfunction: Clinical, Randomized, Controlled and Blind Study
These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.
Read the detailed description
The term temporomandibular disorders (TMD), according to the American American Dental Association (ADA), refers to a group of disorders characterized by pain in the temporomandibular joint (TMD) in the periauricular area or in the masticatory muscles, in addition to TMD sounds during jaw function and deviation or restriction of jaw movements. Its multifactorial etiology is related to a heterogeneous group of functional, structural, and psychological factors, making it difficult to identify the association between a single etiological factor and the signs and symptoms of TMD. As a treatment option, it hasphotobiomodulation, using different light sources, alone or in combination. These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.
- Conditions
- TMJ Pain
- Being tested
- Photobiomodulation using LED, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photobiomodulation using LEDDevice
Photobiomodulation Using a Cluster of LEDs in the Red and Infrared Wavelengths in the Cervical Spine Region and Over the Masticatory Muscles
PlaceboDevice
Photobiomodulation Placebo
| Study group | Role | What they receive |
|---|---|---|
| Photobiomodulation | Experimental | Photobiomodulation using a LED cluster Receives: Device: Photobiomodulation using LED |
| Placebo Photobiomodulation | Placebo comparator | Placebo Photobiomodulation with the equipment turned off Receives: Device: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Baseline
Evaluation of Pain using visual analogic scale in centimeters (0-10cm)
Measured: Before an intervention
Final Pain
Evaluation of Pain using visual analogic scale in centimeters (0-10cm)
Measured: 2 weeks after treatment
Secondary outcomes (4)
Cervical spine mobility baseline
Evaluation of cervical spine mobility using goniometer in degrees
Measured: Before an intervention
Final Cervical spine mobility
Evaluation of cervical spine mobility using goniometer in degrees
Measured: 2 weeks after intervention
Mandibular mobility baseline
Evaluation of mandibular mobility using caliper in millimeters
Measured: Before an intervention
Final Mandibular mobility
Evaluation of mandibular mobility using caliper in millimeters
Measured: 2 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start29 Feb 2024
- Primary completion10 Jul 2024
- Study completion10 Aug 2024
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 TMJ PainStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Carolina Ratto Tempestini Horliana, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06068959
- Sponsor's protocol ID
- 220824a
- Status last verified
- Jul 2026
- First submitted
- 28 Sep 2023
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Trindade LP, Urruty MJ, Bruno LH, Todeschini F, Moya LEP, Lestido V, Dos Santos Malavazzi TC, Motta LJ, Bussadori SK, Fernandes KPS, Horliana ACRT, Mesquita-Ferrari RA. LED Photobiomodulation for Pain Reduction in Temporomandibular Disorder: A Randomized, Controlled, and Blinded Clinical Trial. J Biophotonics. 2026 Mar;19(3):e70243. doi: 10.1002/jbio.70243.
PubMed 41792959
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Photobiomodulation With LED Cluster on Pain and Mandibular and Cervical Mobility in Patients With Temporomandibular Dysfunction: Clinical, Randomized, Controlled and Blind Study
- ClinicalTrials.gov ID
- NCT06068959
- Acronym / sponsor ID
- 220824a
- Conditions
- TMJ Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 10 Jul 2024 (actual)
- Study completion
- 10 Aug 2024 (actual)
- First posted
- 5 Oct 2023 (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.
These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.
Detailed description
The term temporomandibular disorders (TMD), according to the American American Dental Association (ADA), refers to a group of disorders characterized by pain in the temporomandibular joint (TMD) in the periauricular area or in the masticatory muscles, in addition to TMD sounds during jaw function and deviation or restriction of jaw movements. Its multifactorial etiology is related to a heterogeneous group of functional, structural, and psychological factors, making it difficult to identify the association between a single etiological factor and the signs and symptoms of TMD. As a treatment option, it hasphotobiomodulation, using different light sources, alone or in combination. These studies aim to validate the effects of photobiomodulation using clusters of 850nm LEDs (infrared) and 630nm LEDs (red); in pain and cervical and mandibular mobility in patients with TMD. It is a randomized, controlled, and blind clinical trial, which will consist of n= 36, of both genders, with ages ranging from 18 to 45 years, divided into 2 groups: Group 1 Red and infrared LED cluster, Group 2 placebo. The areas where they will receive photobiomodulation will be the TMJ area, masseter muscles, temporal muscles, scalenes, and trapezius. 6 non-consecutive sessions will be performed over 2 weeks. Diagnostic Criteria for Temporomandibular Disorders - DC/TMD will be used to determine TMD and validate participants. To validate the mandibular range of motion (ADM) a pachymeter will be used and for the cervical ADM a goniometer (fleximeter). The pain will be validated using the visual analog scale-VAS. All participants will be evaluated after the first therapeutic intervention, and again at the end, following the same validation procedures used initially.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photobiomodulation | Experimental | Device: Photobiomodulation using LEDPhotobiomodulation using a LED cluster |
| Placebo Photobiomodulation | Placebo comparator | Device: PlaceboPlacebo Photobiomodulation with the equipment turned off |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- present TMD according Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD) Axis I
- have all permanent teeth
Key exclusion criteria (5 listed)
- be undergoing orthodontic treatment
- be undergoing other treatment for TMD
- present dental caries or gingival disease.
- Initiate or use any type of medication during the phases of the study
- comorbidity
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 |
|---|---|---|
| Photobiomodulation using LEDPhotobiomodulation Using a Cluster of LEDs in the Red and Infrared Wavelengths in the Cervical Spine Region and Over the Masticatory Muscles | Device | Photobiomodulation |
| PlaceboPhotobiomodulation Placebo | Device | Placebo Photobiomodulation |
Primary outcome
Pain Baseline
Time frame: Before an intervention
Evaluation of Pain using visual analogic scale in centimeters (0-10cm)
Final Pain
Time frame: 2 weeks after treatment
Evaluation of Pain using visual analogic scale in centimeters (0-10cm)
4 secondary outcomes
Cervical spine mobility baseline
Time frame: Before an intervention
Final Cervical spine mobility
Time frame: 2 weeks after intervention
Mandibular mobility baseline
Time frame: Before an intervention
Final Mandibular mobility
Time frame: 2 weeks after intervention
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 29 Jul 2026.
- Derived from this study: PubMed 41792959Trindade LP, Urruty MJ, Bruno LH, Todeschini F, Moya LEP, Lestido V, Dos Santos Malavazzi TC, Motta LJ, Bussadori SK, Fernandes KPS, Horliana ACRT, Mesquita-Ferrari RA. LED Photobiomodulation for Pain Reduction in Temporomandibular Disorder: A Randomized, Controlled, and Blinded Clinical Trial. J Biophotonics. 2026 Mar;19(3):e70243. doi: 10.1002/jbio.70243.
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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 Photobiomodulation using LED in people with TMJ Pain, run by University of Nove de Julho at 1 site in Brazil.
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 5 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 29 Jul 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 Brazil. 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 Baseline (time frame: Before an intervention). The study lists 2 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 NCT06068959, 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 29 Jul 2026.