Antimicrobial Photodynamic Therapy as an Adjunct Treatment for Periodontal Disease in Down's Syndrome Patients

What Was Tested

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

After scaling and root planning, half of patients received antimicrobial photodynamic therapy with methylene blue dye and laser and the sessions were repeated after 3, 7 and 14 days.

The other half received only scaling and root planning. .

It had two arms (groups): Test group (experimental) and Control Group (active comparator).

Scaling and root planning Repetition after 3, 7 and 14 days.

The registry classes the interventions as device, drug and procedure.

More on the Plan

Therefore, a good adjuvant alternative for periodontal disease treatment arises, especially for patients with Down syndrome (DS) who present greater severity and high prevalence of periodontal disease.

Usually aPDT is used as an adjunct therapy to scaling and root planning.

Who Took Part

33 actual participants took part.

It was open to people of any sex aged from 15 years up to 52 years.

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

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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.

Blinding on both sides kept the gum disease (periodontal) & oral health participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: participant and outcomes assessor.

It started in 2013-10 with completion listed for 2016-10.

It ran at 1 site in Brazil.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity (time frame: one year).

It also tracked 1 secondary outcome, for example Obesity measured by a tape and a scale.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 33 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.