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
NCT ID NCT06834087
First seen Sep 10, 2026 · Last updated Sep 10, 2026
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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45 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Kafrelsheikh University, Faculty of Oral and Dental Medicine
Kafr ash Shaykh, Kafr Ash Shaikh/ Elhamrawy, 33511, Egypt