Comparing the Antibacterial Effect of 810 nm Diode Laser and Photodynamic Therapy

Plain-language guide to NCT02555488: phase 2 randomized trial of Methylene blue (non-peptide stack partner), 20 participants. Who took part, design and what was measured.

Key Facts

Registry ID: NCT02555488
Phase: phase 2
Status: status unknown
Start: 2015-01
Completion (planned or actual): 2015-10
Participants: 20 (estimated)
Design: randomized, open label (everyone knows who gets what), treatment
Conditions studied: Periradicular Disease
Results posted: not yet

What This Study Did, in Plain Language

What Was Tested

In this phase 2 trial, researchers set out to test Methylene blue (non-peptide stack partner).

It had two arms (groups): 2 (experimental) and 1 (experimental).

In the second group diode laser (810 nm, 1.2 W, 30 s) was irradiated. Then second samples were taken from all canals.

In the first group Photodynamic therapy (PDT) with Methylene blue and diode laser (810 nm, 0.2 W, 40 second) was done.

The registry classes the interventions as device and drug.

More on the Plan

This study, therefore, compares two types of diode lasers (low-power and high power) in terms of anti-bacterial effect as well as the conventional endodontic retreatment to determine the ideal method of root canal disinfection.

Who Took Part

20 planned participants were the target.

It was open to people of any sex.

Healthy volunteers could join, not only people with the condition.

How the Study Was Run

Design: randomized, parallel-group and open-label.

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.

The Methylene blue (non-peptide stack partner) group and the comparison group ran side by side rather than switching.

Being open-label, the Methylene blue (non-peptide stack partner) study did not mask who received what.

It started in 2015-01 with completion listed for 2015-10.

It ran at 1 site in Iran.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: bacterial colony forming unit(CFU/ML) (time frame: 12 months).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Methylene blue (non-peptide stack partner) in 20 people.

Its size is small, so on its own it can only give an early look.

Its status is unknown; 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.

Our Notes on the Compound

Methylene blue (non-peptide stack partner): Described as an electron cycler, not just a dye.

Methylene blue (non-peptide stack partner) in the library

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.