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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
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.
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.
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.
Kafrelsheikh University, Faculty of Oral and Dental Medicine
Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, Egypt
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
Time frame: Baseline, 1 Month, 3 Months, and 6 Months Post-Treatment
Healing Time
The duration required for complete epithelialization of the treated gingival area will be recorded. Visual inspection at follow-up visits will determine the time until there is no visible inflammation, erythema, or delayed healing.
Time frame: 1 Month Post-Treatment
Patient Satisfaction
Patient satisfaction will be assessed using a Visual Analog Scale (VAS) questionnaire. Patients will rate their satisfaction with the treatment, including aesthetic improvement, comfort during the procedure, and overall experience on a scale from 0 (completely dissatisfied) to 10 (completely satisfied).
Time frame: 1 Month, 3 Months, and 6 Months Post-Treatment
Recurrence of Gingival Pigmentation
The degree of gingival pigmentation recurrence will be evaluated using clinical and photographic records. Re-pigmentation percentage will be calculated and documented at each follow-up visit.
Time frame: 3 Months and 6 Months Post-Treatment
Adverse Events
Any adverse effects such as persistent erythema, ulceration, or patient-reported pain post-treatment will be documented. A scoring system will be used to assess the severity of these events (e.g., mild, moderate, severe).
Time frame: Throughout the study duration (up to 6 Months Post-Treatment)
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