Facial PainNCT07031505
Effects of Photobiomodulation With Superpulsed Laser and Dual Wavelengths in Children and Adolescents
A study testing Active Photobiomodulation in people with Facial Pain and Headache, run by University of Nove de Julho.
Trial summary
This randomized clinical trial evaluates the effects of photobiomodulation with a superpulsed diode laser (810 + 980 nm) on orofacial pain and tension-type headache in children and adolescents. Sixty participants will be assigned to receive active PBM or sham therapy over eight sessions. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Facial Pain, Headache
- What is being tested?
- Active Photobiomodulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2025to 30 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents 6 to 17 years of age enrolled at the medical and dental clinic of Universidade Nove de Julho (UNINOVE), Vergueiro Campus;
- Children and adolescents who present with at least one symptom of orofacial pain and/or headache, according to the Faces Pain Scale and the childhood and adolescence headache questionnaire based on the ICHD-3
Who cannot join
- Pregnant adolescents;
- Having taken corticoids, non-steroidal anti-inflammatory drugs or analgesics in the previous 30 days;
- Having taken isotretinoin;
- Individuals who report photosensitivity to laser or LED in previous treatments.
About this study
Official title: Effects of Photobiomodulation With Superpulsed Laser and Dual Wavelength (810 + 980 NM) in Children and Adolescents With Facial Muscle Pain and Headache: Protocol for a Randomized Controlled Clinical Trial
This randomized clinical trial evaluates the effects of photobiomodulation with a superpulsed diode laser (810 + 980 nm) on orofacial pain and tension-type headache in children and adolescents. Sixty participants will be assigned to receive active PBM or sham therapy over eight sessions. Pain and anthropometric variables will be assessed.
Read the detailed description
Orofacial pain and tension-type headache are common in children and adolescents, often impairing school performance, social interactions, and functional development. Due to potential side effects of pharmacological treatments, non-pharmacological alternatives like photobiomodulation (PBM) are being studied. This protocol evaluates the effects of PBM with a superpulsed dual-wavelength diode laser (810 nm + 980 nm) applied to masseter and temporal muscles across eight sessions. Sixty participants (aged 6-17) will be randomized into two groups: G1 (active PBM) and G2 (sham). Anthropometric data (age, weight, height, BMI, Fitzpatrick phototype), penetrated energy, and local temperature will be recorded. Pain will be assessed using the Faces Pain Scale and the ICHD-3 questionnaire. The primary outcome is pain reduction. Secondary outcomes include correlations between anthropometric factors, energy penetration, and clinical response. A linear mixed model with repeated measures will be used for statistical analysis.
- Conditions
- Facial Pain, Headache
- Being tested
- Active Photobiomodulation, Sham Photobiomodulation
- Medical subject headings
- Facial Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PhotobiomodulationDevice
Local photobiomodulation using a high-power superpulsed diode laser (GeminiEvo, Ultradent, USA) with dual infrared wavelengths (810 nm and 980 nm). Eight sessions will be conducted (twice a week for 4 weeks). Application will be at one point each on the masseter, temporal, trapezius, and temporomandibular joint regions. Each point will be irradiated for 13 seconds with 4 J of energy (10.52 J/cm²), in contact mode. The procedure includes safety measures such as protective eyewear and disinfection of the laser tip.
Sham PhotobiomodulationDevice
The same application protocol as the experimental group will be followed, using the same laser device (GeminiEvo, Ultradent, USA), but with the laser emission deactivated. The guide light and sound will remain active to preserve participant blinding. Application points, duration, frequency, and session environment will be identical to the active group.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Local photobiomodulation | Experimental | Participants in this arm will receive local photobiomodulation using a high-power superpulsed diode laser (GeminiEvo, Ultradent, USA) with dual wavelengths (810 nm and 980 nm). The protocol consists of 8 sessions (twice weekly for 4 weeks), with laser applied to the masseter, temporal, trapezius, and temporomandibular joint (TMJ) regions. Each point will be irradiated for 13 seconds using 4 J of energy (10.52 J/cm²) with a contact technique. Safety procedures include use of protective eyewear and disinfection of the device tip. Receives: Device: Active Photobiomodulation |
| Group 2 - Sham local photobiomodulation | Sham comparator | Participants in this arm will undergo the same treatment protocol as the experimental group. However, the device will be deactivated (no laser emission), while maintaining the guide light and operational sounds to ensure participant blinding. All application parameters and session conditions will mimic the active group. Receives: Device: Sham Photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity based on Faces Pain Scale
The Faces Pain Scale will be completed weekly by the legal guardians during the second therapeutic session of each treatment week.
Measured: Weekly, up to 4 weeks
Headache classification using ICHD-3
The ICHD-3 questionnaire will be completed weekly by the legal guardians during the second therapeutic session of each treatment week.
Measured: Weekly, up to 4 weeks
Secondary outcomes (2)
Light transmission
Light transmission will be assessed through each participant's index finger and cheek (masseter muscle) using a SPER Scientific Pocket Laser Power Meter. The measurement will follow the Yaroslavsky method and will be collected during the first treatment session.
Measured: Day 1
Local temperature
Temperature will be measured using a dual infrared laser thermometer during the first treatment session, specifically during the application of photobiomodulation.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sandra Kalil Bussadori, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031505
- Sponsor's protocol ID
- SuperpulsedLaser
- Status last verified
- Jun 2025
- First submitted
- 4 Jun 2025
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Photobiomodulation With Superpulsed Laser and Dual Wavelength (810 + 980 NM) in Children and Adolescents With Facial Muscle Pain and Headache: Protocol for a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07031505
- Acronym / sponsor ID
- SuperpulsedLaser
- Conditions
- Facial Pain, Headache
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 22 Jun 2025 (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.
This randomized clinical trial evaluates the effects of photobiomodulation with a superpulsed diode laser (810 + 980 nm) on orofacial pain and tension-type headache in children and adolescents. Sixty participants will be assigned to receive active PBM or sham therapy over eight sessions. Pain and anthropometric variables will be assessed.
Detailed description
Orofacial pain and tension-type headache are common in children and adolescents, often impairing school performance, social interactions, and functional development. Due to potential side effects of pharmacological treatments, non-pharmacological alternatives like photobiomodulation (PBM) are being studied. This protocol evaluates the effects of PBM with a superpulsed dual-wavelength diode laser (810 nm + 980 nm) applied to masseter and temporal muscles across eight sessions. Sixty participants (aged 6-17) will be randomized into two groups: G1 (active PBM) and G2 (sham). Anthropometric data (age, weight, height, BMI, Fitzpatrick phototype), penetrated energy, and local temperature will be recorded. Pain will be assessed using the Faces Pain Scale and the ICHD-3 questionnaire. The primary outcome is pain reduction. Secondary outcomes include correlations between anthropometric factors, energy penetration, and clinical response. A linear mixed model with repeated measures will be used for statistical analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Local photobiomodulation | Experimental | Device: Active PhotobiomodulationParticipants in this arm will receive local photobiomodulation using a high-power superpulsed diode laser (GeminiEvo, Ultradent, USA) with dual wavelengths (810 nm and 980 nm). The protocol consists of 8 sessions (twice weekly for 4 weeks), with laser applied to the masseter, temporal, trapezius, and temporomandibular joint (TMJ) regions. Each point will be irradiated for 13 seconds using 4 J of energy (10.52 J/cm²) with a contact technique. Safety procedures include use of protective eyewear and disinfection of the device tip. |
| Group 2 - Sham local photobiomodulation | Sham comparator | Device: Sham PhotobiomodulationParticipants in this arm will undergo the same treatment protocol as the experimental group. However, the device will be deactivated (no laser emission), while maintaining the guide light and operational sounds to ensure participant blinding. All application parameters and session conditions will mimic the active group. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children and adolescents 6 to 17 years of age enrolled at the medical and dental clinic of Universidade Nove de Julho (UNINOVE), Vergueiro Campus;
- Children and adolescents who present with at least one symptom of orofacial pain and/or headache, according to the Faces Pain Scale and the childhood and adolescence headache questionnaire based on the ICHD-3
Key exclusion criteria (4 listed)
- Pregnant adolescents;
- Having taken corticoids, non-steroidal anti-inflammatory drugs or analgesics in the previous 30 days;
- Having taken isotretinoin;
- Individuals who report photosensitivity to laser or LED in previous treatments.
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 |
|---|---|---|
| Active PhotobiomodulationLocal photobiomodulation using a high-power superpulsed diode laser (GeminiEvo, Ultradent, USA) with dual infrared wavelengths (810 nm and 980 nm). Eight sessions will be conducted (twice a week for 4 weeks). Application will be at one point each on the masseter, temporal, trapezius, and temporomandibular joint regions. Each point will be irradiated for 13 seconds with 4 J of energy (10.52 J/cm²), in contact mode. The procedure includes safety measures such as protective eyewear and disinfection of the laser tip. | Device | Group 1 - Local photobiomodulation |
| Sham PhotobiomodulationThe same application protocol as the experimental group will be followed, using the same laser device (GeminiEvo, Ultradent, USA), but with the laser emission deactivated. The guide light and sound will remain active to preserve participant blinding. Application points, duration, frequency, and session environment will be identical to the active group. | Device | Group 2 - Sham local photobiomodulation |
Primary outcome
Pain intensity based on Faces Pain Scale
Time frame: Weekly, up to 4 weeks
The Faces Pain Scale will be completed weekly by the legal guardians during the second therapeutic session of each treatment week.
Headache classification using ICHD-3
Time frame: Weekly, up to 4 weeks
The ICHD-3 questionnaire will be completed weekly by the legal guardians during the second therapeutic session of each treatment week.
2 secondary outcomes
Light transmission
Time frame: Day 1
Local temperature
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Active Photobiomodulation in people with Facial Pain and Headache, run by University of Nove de Julho.
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 4 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: opening soon, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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 intensity based on Faces Pain Scale (time frame: Weekly, up to 4 weeks). 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?
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 22 Jun 2025.