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ENROLLING BY INVITATION
NCT06834087
NA

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

Sponsor: Roaa Hadi Hussein Jasem

View on ClinicalTrials.gov

Summary

This randomized controlled clinical trial aims to compare the effectiveness of methylene blue and methylene blue nanoparticles as adjuncts to photodynamic therapy in laser treatment of physiological gingival pigmentation. The study evaluates pigmentation reduction, recurrence rates, healing time, and patient satisfaction. Conducted at Kafrelsheikh University, it includes three patient groups: laser-only treatment, conventional methylene blue-assisted PDT with laser, and methylene blue nanoparticles-assisted PDT with laser. The findings will contribute to advancements in aesthetic dentistry and laser-assisted depigmentation techniques.

Official title: Comparative Evaluation of Methylene Blue and Methylene Blue Nanoparticles Assisted Photodynamic Therapy As Adjunctive to Laser Treatment of Physiological Gingival Pigmentation: a Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

45

Start Date

2025-03-15

Completion Date

2025-11-15

Last Updated

2025-02-19

Healthy Volunteers

No

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).

Locations (1)

Kafrelsheikh University, Faculty of Oral and Dental Medicine

Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, Egypt