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Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabetes Mellitus

Plain-language guide to NCT07463859: not phased randomized trial of Methylene blue (non-peptide stack partner), 32 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07463859
Phase
not phased
Status
recruiting participants
Start
2026-04-02
Completion (planned or actual)
2027-01-31
Participants
32 (estimated)
Design
randomized, triple-blind, treatment
Conditions studied
Type 2 Diabetes; Halitosis; 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).

It had two arms (groups): aPDT - antimicrobial photodynamic therapy (experimental) and Control (active comparator).

Treatment of scaling and root planning plus antimicrobial photodynamic therapy in periodontal pockets. Antimicrobial photodynamic therapy on tongue.

Treatment of periodontal pockets with scaling and root planing and tongue with tongue scraper.

The registry classes the interventions as procedure.

Who Took Part

The registry lists 32 planned participants were the target.

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

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

Examples of who could join: Patients diagnosed with type 2 diabetes mellitus according to the 2019 WHO criteria. Stage 3 or 4 periodontitis. No periodontal treatment in the previous 12 months. A minimum of 20 remaining teeth.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: alcohol-dependent individuals; pregnant or lactating women; patients with renal disorders.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The 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.

Blinding on both sides kept the participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2026-04-02 with completion listed for 2027-01-31.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Halitosis (time frame: From enrollment to the end of treatment at 6 months).

It also tracked 2 secondary outcomes, for example Probing depth and Clinical Attachment level.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 32 people.

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

It is still recruiting; 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.

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.