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

NCT ID: NCT06834087

Last Updated: 2025-02-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-15
• Study Completion Date: 2025-11-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1 (Control Group) Laser-Only Treatment

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.

Group Type: OTHER

Laser-Assisted Gingival Depigmentation

Intervention Type: 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 2 (Experimental Group 1) PDT with Conventional Methylene Blue + Laser

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).

Group Type: EXPERIMENTAL

Photodynamic Therapy with Conventional Methylene Blue

Intervention Type: 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 3 (Experimental Group 2) PDT with Methylene Blue Nanoparticles + Laser

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).

Group Type: ACTIVE_COMPARATOR

Photodynamic Therapy with Methylene Blue Nanoparticles

Intervention Type: 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).

Interventions

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.

Intervention Type: PROCEDURE

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roaa Hadi Hussein Jasem

OTHER

Sponsor Role: lead

Responsible Party

Roaa Hadi Hussein Jasem

B.D.S. 2013 ALANBAR UNIVERSITY FACULTY OF DENTISTRY

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kafrelsheikh University, Faculty of Oral and Dental Medicine

Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, Egypt

Countries

Egypt

Other Identifiers

Kfsirb200-489

Identifier Type: -

Identifier Source: org_study_id