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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
45
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.
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).
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).
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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