Effects of Photobiomodulation With Superpulsed Laser and Dual Wavelengths in Children and Adolescents
June 12, 2025 updated by: Sandra Kalil Bussadori, University of Nove de Julho
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 - Local photobiomodulation
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.
|
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 Comparator: Group 2 - Sham local photobiomodulation
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Weekly, up to 4 weeks
|
|
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.
|
Weekly, up to 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Light transmission
Time Frame: Day 1
|
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.
|
Day 1
|
|
Local temperature
Time Frame: Day 1
|
Temperature will be measured using a dual infrared laser thermometer during the first treatment session, specifically during the application of photobiomodulation.
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2025
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
April 30, 2026
Study Registration Dates
First Submitted
June 4, 2025
First Submitted That Met QC Criteria
June 12, 2025
First Posted (Actual)
June 22, 2025
Study Record Updates
Last Update Posted (Actual)
June 22, 2025
Last Update Submitted That Met QC Criteria
June 12, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SuperpulsedLaser
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.