Physiological Gingival Pigmentation
Conditions
Keywords
Gingival Pigmentation, Laser Therapy, Photodynamic Therapy, Methylene Blue, Nanoparticles, Periodontology, Aesthetic Dentistry
Brief 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.
Interventions
PROCEDURELaser-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.
DRUGDrug: 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.
DRUGDrug: 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.
Sponsors
Roaa Hadi Hussein Jasem
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in Gingival Pigmentation | Baseline, 1 Month, 3 Months, and 6 Months Post-Treatment | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Healing Time | 1 Month Post-Treatment | 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. |
| Patient Satisfaction | 1 Month, 3 Months, and 6 Months Post-Treatment | 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). |
| Recurrence of Gingival Pigmentation | 3 Months and 6 Months Post-Treatment | 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. |
| Adverse Events | Throughout the study duration (up to 6 Months Post-Treatment) | 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). |
Countries
Egypt
Outcome results
None listed