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

NCT07031505 | Not Yet Recruiting DMC

• 1 other identifier: SuperpulsedLaser
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Facial Pain; Headache

Outcome Measures

Primary Outcomes (2)

• 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.

  Weekly, up to 4 weeks

• 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.

  Weekly, up to 4 weeks

Secondary Outcomes (2)

• Light transmission

  Day 1

• Local temperature

  Day 1

Study Arms (2)

Group 1 - Local photobiomodulation

EXPERIMENTAL

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.

Device: Active Photobiomodulation

Group 2 - Sham local photobiomodulation

SHAM COMPARATOR

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.

Device: Sham Photobiomodulation

Interventions

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.

Group 1 - Local photobiomodulation

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.

Group 2 - Sham local photobiomodulation

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Facial Pain; Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 4, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: April 30, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-06