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

ConditionsFacial PainHeadache
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-17
SponsorUniversity of Nove de Julho

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Group 1 - Local photobiomodulationExperimental treatment 1 intervention
Group B: Group 2 - Sham local photobiomodulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Weekly, up to 4 weeks
2

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.

Time frame
Weekly, up to 4 weeks

Secondary outcomes

1

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.

Time frame
Day 1
2

Local temperature

Temperature will be measured using a dual infrared laser thermometer during the first treatment session, specifically during the application of photobiomodulation.

Time frame
Day 1

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nove de Julho

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: