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NOT YET RECRUITING
NCT07031505
NA

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

Sponsor: University of Nove de Julho

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-07-01

Completion Date

2026-04-30

Last Updated

2025-06-22

Healthy Volunteers

No

Interventions

DEVICE

Active Photobiomodulation

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.

DEVICE

Sham Photobiomodulation

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.