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Photodynamic in Periodontal Treatment

Plain-language guide to NCT05162417: not phased randomized trial of Methylene blue (non-peptide stack partner), gum disease (periodontal) & oral health, 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05162417
Phase
not phased
Status
completed
Start
2021-11-15
Completion (planned or actual)
2022-11-01
Participants
18 (actual)
Design
randomized, single-blind, treatment
Conditions studied
Periodontal Diseases; Periodontal Pocket
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered not phased trial tested Methylene blue (non-peptide stack partner) for gum disease (periodontal) & oral health.

Dental biofilm is a primary etiological factor for periodontal diseases.(1) The bacterial biofilm would induce recruitment of leucocytes, neutrophils, and T lymphocytes and the secretion of antibodies, lipopolysaccharides, and chemical inflammatory mediators such as cytokines and chemokines.(2) Thus, periodontal diseases can cause tissue destruction and results in deterioration of clinical parameters measures such as periodontal pockets depth, clinical attachment loss, bleeding on probing, bone destruction, and resulting ultimately in tooth loss.(3).

It had three arms (groups): Control group (no intervention), Test group (toluidine Blue O) (experimental) and Methylene blue (experimental).

Patient in this arm will receive scaling and root planning treatment only.

Patients in this arm will receive Toluidine Blue O as an adjunctive to scaling and root planing.

Patients will receive Methylene blue as adjunctive to scaling and root planning.

The registry classes the interventions as other.

Who Took Part

Enrollment: 18 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: Each patient should have at least four teeth with a probing depth ≥of 5mm.

The full record lists 2 inclusion and 4 exclusion criteria; among the exclusions: patients receiving periodontal therapy and/or antibiotics within the previous six months; patients with diseases or medication with an inhibitory or promoting effect on periodontal healing, including anticoagulants, anti-inflammatories; pregnant or nursing women.

How the Study Was Run

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

The gum disease (periodontal) & oral health participants were allocated by chance, so the Methylene blue (non-peptide stack partner) group and the comparison group should start out alike.

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

Only one side, usually the gum disease (periodontal) & oral health participants, was kept unaware of whether Methylene blue (non-peptide stack partner) was given.

Those kept unaware of assignments: participant.

It started in 2021-11-15 with completion listed for 2022-11-01.

It ran at 1 site in Iraq.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in probing pocket depth (time frame: At the base line and three months). Change in clinical attachment loss (time frame: At the base line and three months).

It also tracked 1 secondary outcome, for example Change in bleeding on Probing.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 18 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.