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Enrolling by Invitation

NCT Number: NCT06834087

Laser Treatment with Methylene Blue Vs. Nanoparticle-Assisted Photodynamic Therapy for Gingival Pigmentation: a Randomized Clinical Trial

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.

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Key information

Conditions

Physiological Gingival Pigmentation

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University, Faculty of Oral and Dental Medicine

Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, 33511, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laser-Assisted Gingival Depigmentation

Procedure

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.

Photodynamic Therapy with Conventional Methylene Blue

Drug

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).

Photodynamic Therapy with Methylene Blue Nanoparticles

Drug

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 outcomes

  1. Reduction in Gingival Pigmentation

    Time frame: 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 outcomes

  1. Healing Time

    Time frame: 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.

  2. Patient Satisfaction

    Time frame: 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).

  3. Recurrence of Gingival Pigmentation

    Time frame: 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.

  4. Adverse Events

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Roaa Hadi Hussein Jasem

Other

Registry information

Official study 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

Acronym: MB-Laser-GP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 19, 2025
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.