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

Roaa Hadi Hussein Jasem

Status: Invitation-only

Conditions: Physiological Gingival Pigmentation

Treatments: Drug: Photodynamic Therapy with Conventional Methylene Blue; Drug: Photodynamic Therapy with Methylene Blue Nanoparticles; Procedure: Laser-Assisted Gingival Depigmentation

Study type: Interventional

Funder types: Other

Identifiers

NCT06834087

Kfsirb200-489

Details and patient eligibility

About

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.

Enrollment: 45 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 3 patient groups

Arm 1 (Control Group) Laser-Only Treatment

Other group

Description:

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.

Treatment:

Procedure: Laser-Assisted Gingival Depigmentation

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

Experimental group

Description:

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).

Treatment:

Drug: Photodynamic Therapy with Conventional Methylene Blue

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

Active Comparator group

Description:

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).

Treatment:

Drug: Photodynamic Therapy with Methylene Blue Nanoparticles