Laser Treatment with Methylene Blue Vs. Nanoparticle-Assisted Photodynamic Therapy for Gingival Pigmentation: a Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laser-Assisted Gingival Depigmentation, Photodynamic Therapy with Conventional Methylene Blue, Photodynamic Therapy with Methylene Blue Nanoparticles.
- Who it may be relevant to
- Registry conditions: Physiological Gingival Pigmentation. Basic parameters: 18 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Procedure Laser-Assisted Gingival Depigmentation
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. - Drug Photodynamic Therapy with Conventional Methylene Blue
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). - Drug Photodynamic Therapy with Methylene Blue Nanoparticles
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).
Primary outcome measures
- Reduction in Gingival Pigmentation [Time frame: Baseline, 1 Month, 3 Months, and 6 Months Post-Treatment]
Secondary outcome measures (4)
- Healing Time [Time frame: 1 Month Post-Treatment]
- Patient Satisfaction [Time frame: 1 Month, 3 Months, and 6 Months Post-Treatment]
- Recurrence of Gingival Pigmentation [Time frame: 3 Months and 6 Months Post-Treatment]
- Adverse Events [Time frame: Throughout the study duration (up to 6 Months Post-Treatment)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Kafrelsheikh University, Faculty of Oral and Dental Medicine — Kafr ash Shaykh
Identifiers
NCT: NCT06834087 · Kfsirb200-489