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

NCT06834087 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-02-19

No results posted yet for this study

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.

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).

Sponsors & Collaborators

  • Roaa Hadi Hussein Jasem

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2025-09-14
Completion
2025-11-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06834087 on ClinicalTrials.gov