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Laser Treatment With Methylene Blue vs. Nanoparticle-Assisted Photodynamic Therapy for Gingival Pigmentation: A Randomized Clinical Trial
Sponsor: Roaa Hadi Hussein Jasem
Summary
This prospective, randomized, controlled, single-blinded, three-arm clinical trial compared the clinical effectiveness of conventional methylene blue-mediated photodynamic therapy (MB-PDT) and methylene blue nanoparticle-mediated photodynamic therapy (MB-NP-PDT) as adjuncts to diode-laser treatment of physiological gingival pigmentation. A total of 45 systemically healthy participants with physiological gingival pigmentation were randomly allocated in a 1:1:1 ratio to three groups: diode-laser gingival depigmentation alone, conventional 0.1% methylene blue PDT followed by diode-laser depigmentation, or 0.1% methylene blue nanoparticle PDT followed by diode-laser depigmentation. Participants were followed for 6 months. The study assessed gingival pigmentation reduction, complete pigmentation clearance, recurrence, objective gingival color changes, epithelialization and healing time, postoperative pain, patient satisfaction, and treatment-related adverse events.
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
2026-09-10
Healthy Volunteers
No
Conditions
Interventions
Laser-Assisted Gingival Depigmentation
This intervention involved diode-laser gingival depigmentation using the SiroLaser Blue system (Dentsply Sirona) at a wavelength of 970 nm and an output power of 1.5 W in continuous-wave mode. A 320-µm fiber tip was used in contact mode and moved continuously with gentle sweeping strokes over the pigmented gingival surface for approximately 30 seconds per treatment site.
Drug: Conventional Methylene Blue-Mediated Photodynamic Therapy
This intervention consisted of applying a 0.1% conventional methylene blue solution uniformly to the pigmented gingival surface using a sterile microbrush. The photosensitizer was allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual photosensitizer. Diode-laser gingival depigmentation was then performed using the 970-nm, 1.5-W continuous-wave protocol with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site.
Drug: Methylene Blue Nanoparticle-Mediated Photodynamic Therapy
This intervention consisted of applying a 0.1% methylene blue nanoparticle formulation uniformly to the pigmented gingival surface using a sterile microbrush. The formulation was allowed to remain in contact with the gingiva for 2 minutes before photoactivation. Photodynamic activation was performed using a 660-nm diode laser at an output power of 100 mW in continuous-wave, non-contact mode for 60 seconds per treatment site. The gingival surface was subsequently irrigated with sterile saline to remove residual formulation. Diode-laser gingival depigmentation was then performed using a 970-nm diode laser at 1.5 W in continuous-wave mode with a 320-µm fiber tip in contact mode for approximately 30 seconds per treatment site.
Locations (1)
Kafrelsheikh University, Faculty of Oral and Dental Medicine
Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, Egypt