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

NCT06834087 | Enrolling By Invitation DMC

• 1 other identifier: Kfsirb200-489
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Gingival Pigmentation, Laser Therapy, Photodynamic Therapy, Methylene Blue, Nanoparticles, Periodontology, Aesthetic Dentistry

Outcome Measures

Primary Outcomes (1)

• Reduction in Gingival Pigmentation

  The primary outcome will be assessed by evaluating changes in gingival pigmentation using clinical photographs and a standardized pigmentation index. Digital images of the treated gingival areas will be analyzed for pigmentation intensity reduction using imaging software. The pigmentation index scores range from: Score 0: Absence of pigmentation Score 1: Spots of brown to black color Score 2: Brown to black patches without diffuse pigmentation Score 3: Diffuse brown to black pigmentation

  Baseline, 1 Month, 3 Months, and 6 Months Post-Treatment

Secondary Outcomes (4)

• Healing Time

  1 Month Post-Treatment

• Patient Satisfaction

  1 Month, 3 Months, and 6 Months Post-Treatment

• Recurrence of Gingival Pigmentation

  3 Months and 6 Months Post-Treatment

• Adverse Events

  Throughout the study duration (up to 6 Months Post-Treatment)

Study Arms (3)

Arm 1 (Control Group) Laser-Only Treatment

OTHER

Patients in this group will undergo laser-assisted gingival depigmentation using a diode laser (970 nm wavelength, 2.0 W power, continuous mode) with a 200 µm fiber tip applied for 30 seconds per site in contact mode.

Procedure: Laser-Assisted Gingival Depigmentation

Arm 2 (Experimental Group 1) PDT with Conventional Methylene Blue + Laser

EXPERIMENTAL

This group will receive photodynamic therapy (PDT) using a conventional methylene blue solution (0.1%), applied for 2 minutes before activation with a 660 nm diode laser (1.5 W, pulsed mode, 60 seconds per site). This will be followed by laser-assisted gingival depigmentation using a diode laser (970 nm wavelength, 2.0 W power, continuous mode, 200 µm fiber tip, 30 seconds per site).

Drug: Photodynamic Therapy with Conventional Methylene Blue

Arm 3 (Experimental Group 2) PDT with Methylene Blue Nanoparticles + Laser

ACTIVE COMPARATOR

Patients in this group will receive PDT with methylene blue nanoparticles (0.1%) applied for 2 minutes before activation with a 660 nm diode laser (1.5 W, pulsed mode, 60 seconds per site). This will be followed by laser-assisted gingival depigmentation using a diode laser (970 nm wavelength, 2.0 W power, continuous mode, 200 µm fiber tip, 30 seconds per site).

Drug: Photodynamic Therapy with Methylene Blue Nanoparticles

Interventions

Laser-Assisted Gingival Depigmentation PROCEDURE

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.

Arm 1 (Control Group) Laser-Only Treatment

Photodynamic Therapy with Conventional Methylene Blue DRUG

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).

Arm 2 (Experimental Group 1) PDT with Conventional Methylene Blue + Laser

Photodynamic Therapy with Methylene Blue Nanoparticles DRUG

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).

Arm 3 (Experimental Group 2) PDT with Methylene Blue Nanoparticles + Laser

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with physiological gingival pigmentation confirmed by clinical examination.
• Age range: 18-50 years.
• Patients with no history of systemic diseases or conditions that could affect wound healing (e.g., diabetes, autoimmune diseases).
• Patients willing to undergo laser treatment and provide informed consent.
• Non-smokers or individuals who have stopped smoking for at least six months.

You may not qualify if:

• Patients with pathological gingival pigmentation (e.g., associated with syndromes or systemic conditions).
• Use of medications affecting pigmentation or healing (e.g., anticoagulants, immunosuppressants).
• Pregnant or lactating women or those taking contraceptive drugs.
• Individuals with known allergies to methylene blue or nanoparticles.

Sponsors & Collaborators

• Roaa Hadi Hussein Jasem: lead

Study Sites (1)

Kafrelsheikh University, Faculty of Oral and Dental Medicine

Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, 33511, Egypt

Location

MeSH Terms

Interventions

Photochemotherapy

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

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: SPONSOR INVESTIGATOR
• PI Title: B.D.S. 2013 ALANBAR UNIVERSITY FACULTY OF DENTISTRY

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 19, 2025
• Study Start: March 15, 2025
• Primary Completion: September 14, 2025
• Study Completion: November 15, 2025
• Last Updated: February 19, 2025

Record last verified: 2025-02

Locations

EG (1)