Laser Treatment With Methylene Blue vs. Nanoparticle-Assisted Photodynamic Therapy for Gingival Pigmentation: A Randomized Clinical Trial

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner).

Participants were followed for 6 months.

It had three arms (groups): Arm 1 (Control): Diode-Laser Gingival Depigmentation Alone (active comparator), Arm 2: Conventional Methylene Blue-PDT Plus Diode-Laser Depigmentation (experimental) and Arm 3: Methylene Blue Nanoparticle-PDT Plus Diode-Laser Depigmentation (experimental).

Participants assigned to this arm received diode-laser gingival depigmentation alone using the SiroLaser Blue diode laser (Dentsply Sirona). The laser was operated 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.

The registry classes the interventions as drug and procedure.

Who Took Part

Enrollment: 45 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

Because people in this Methylene blue (non-peptide stack partner) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.

Those kept unaware of assignments: participant.

It started in 2025-03-15 with completion listed for 2025-09-14.

It ran at 1 site in Egypt.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 4 secondary outcomes, for example Healing Time, Patient Satisfaction, Recurrence of Gingival Pigmentation and Adverse Events.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 45 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Methylene blue (non-peptide stack partner) compound page, all human trials.