Laser Treatment with Methylene Blue Vs. Nanoparticle-Assisted Photodynamic Therapy for Gingival Pigmentation: a Randomized Clinical Trial

NAEnrolling by invitationINTERVENTIONAL
Enrollment

45

Participants

Timeline

Start Date

March 15, 2025

Primary Completion Date

September 14, 2025

Study Completion Date

November 15, 2025

Conditions
Physiological Gingival Pigmentation
Interventions
PROCEDURE

Laser-Assisted Gingival Depigmentation

This intervention involves the use of a diode laser (970 nm wavelength, 2.0 W power, continuous mode) with a 200 µm fiber tip. The laser is applied in a sweeping motion over the pigmented gingiva in contact mode for 30 seconds per site to achieve depigmentation.

DRUG

Photodynamic Therapy with Conventional Methylene Blue

This intervention consists of applying a 0.1% methylene blue solution to the pigmented gingiva for 2 minutes before activation with a diode laser (660 nm wavelength, 1.5 W power, pulsed mode) for 60 seconds per site. This is followed by laser-assisted gingival depigmentation using a 970 nm diode laser (2.0 W, continuous mode, 200 µm fiber tip, 30 seconds per site).

DRUG

Photodynamic Therapy with Methylene Blue Nanoparticles

This intervention involves the application of 0.1% methylene blue nanoparticles to the pigmented gingiva for 2 minutes to allow deeper tissue penetration. It is then activated using a diode laser (660 nm wavelength, 1.5 W power, pulsed mode) for 60 seconds per site, followed by laser-assisted gingival depigmentation using a 970 nm diode laser (2.0 W, continuous mode, 200 µm fiber tip, 30 seconds per site).

Trial Locations (1)

33511

Kafrelsheikh University, Faculty of Oral and Dental Medicine, Kafr ash Shaykh

All Listed Sponsors
lead

Roaa Hadi Hussein Jasem

OTHER