Evaluation of Chlorhexidine Gel Associated with Photodynamic Therapy in the Treatment of Chronic Periodontitis in Type 2 Diabetics

What Was Tested

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

So, 20 periodontitis patients will be selected.

It had two arms (groups): one (experimental) and Control (C) - Saline Gel (placebo comparator).

The registry classes the interventions as procedure.

More on the Plan

Periodontal disease is a polymicrobial inflammatory condition caused by infection of periodontal tissues resulting from the accumulation of bacterial biofilm, which can result in the progressive loss of the conjunctival attachment and alveolar bone.

The destructive nature of diseases and their progression depend on the composition of the supra and subgingival biofilm.

In response to the imbalance between host and microorganisms, the host can respond to biofilm products by generating periodontal infection.

This process can result in the production of enzymes and other endogenous mediators of the inflammatory response, being responsible for much of the tissue destruction observed through clinical and histopathological parameters.

Who Took Part

The registry lists 20 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

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

Examples of who could join: Participants over 18 years old. Adults with type 2 diabetics. Adults with periodontal disease. Pockets with probing depth greater than 5 mm.

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: participants with hypersensitivity to the components of chlorhexidine gel or methylene blue and laser therapy; drugs ( alcoholics, anti-inflammatories and antibiotics in the last 6 months); osteoporosis types i and ii.

How the Study Was Run

Design: randomized, sequential and double-blind.

Random assignment meant chance, not the researchers, decided who got Methylene blue (non-peptide stack partner) and who got the comparison, which limits bias.

As a double-blind Methylene blue (non-peptide stack partner) study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant and investigator.

It started in 2024-05-30 with completion listed for 2024-10-07.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: glycemic control (time frame: Baseline and 3 months after). Plaque index (IP) (time frame: Baseline and 3 months after). Clinical Attachment Level (CAL) (time frame: Baseline and 3 months after).

What This Means in Plain Language

Put simply, this is a not phased, 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.

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.