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NCT Number: NCT07031505

Effects of Photobiomodulation With Superpulsed Laser and Dual Wavelengths in Children and Adolescents

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.

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Key information

Conditions

Facial Pain Headache Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Active Photobiomodulation

Device

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 photobiomodulation

Device

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Nove de Julho

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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