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Dose Parameters for Photodynamic Therapy on Periodontal Disease

Plain-language guide to NCT03262077: not phased randomized trial of Methylene blue (non-peptide stack partner), gum disease (periodontal) & oral health, 30 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03262077
Phase
not phased
Status
completed
Start
2016-10-11
Completion (planned or actual)
2017-06-26
Participants
30 (actual)
Design
randomized, open label (everyone knows who gets what), basic_science
Conditions studied
Chronic Periodontitis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Methylene blue (non-peptide stack partner) for gum disease (periodontal) & oral health.

The objective of this research was to investigate the tissue dosimetric parameters used in PDT for the treatment of periodontal disease.

It had six arms (groups): MB 1 min (experimental), MB 3 min (experimental), MB 5 min (experimental), MBS 1 min (experimental) and MBS 3 min (experimental).

Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 1 min.

Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 3 min.

Methylene blue 100 μM photosensitizer was deposited in the periodontal pocket of one incisor and 1 min of pre-irradiation time was adopted to allow the drug to stain the bacterial biofilm. Then the laser emitting wavelength of 660 nm, with power of 100 mW, was applied to the mucosa during 5 min.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Patient with chronic periodontitis;. The patient should have at least 15 teeth present, with a minimum of 3 incisors with depth of probing greater than 4 mm;. Minimum age of 18 years.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: current smokers or regular smoking 12 months prior to enrollment;; patients with anemia,; patients with active cancer;.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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 gum disease (periodontal) & oral health participants stayed in one arm throughout.

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

It started in 2016-10-11 with completion listed for 2017-06-26.

Its stated primary purpose is basic science.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 30 people with gum disease (periodontal) & oral health.

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

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, Gum disease (periodontal) & oral health research.

Our Notes on the Compound

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

Related Pages

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.