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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Nove de Julho
- Enrollment
- 60
- Primary Endpoint
- Pain intensity based on Faces Pain Scale
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Active Photobiomodulation (Device)
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.
Intervention: Sham Photobiomodulation (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Light transmission(Day 1)
- Local temperature(Day 1)
Investigators
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho