Impact of Photodynamic Therapy as an Adjunct to Non-surgical Periodontal Treatment on Clinical and Biochemical Parameters Among Patients Having Mild Rheumatoid Arthritis With Periodontitis

What Was Tested

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

Methods: A total of 50 RA patients with periodontitis were included.

The subjects were equally divided into two groups: Group A - scaling and root planning (SRP) + PDT; Group B - SRP only, respectively.

It had two arms (groups): Methylene blue mediated photodynamic therapy (experimental) and Scaling and root planing (placebo comparator).

The registry classes the interventions as device and procedure.

Who Took Part

The registry lists 50 actual participants took part.

It was open to people of any sex aged from 25 years up to 60 years.

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

Examples of who could join: Patients aged ≥25 years. Satisfying the 2010 ACR/EULAR categorization criteria (with active RA with ≥6 joint involvement and under anti-RA medication ≥3 months).

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: patients who had underwent periodontal therapy or antimicrobial therapy in the last 6 months; any joint replacement; pregnancy/lactating mothers.

How the Study Was Run

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

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.

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 rheumatoid arthritis participants and researchers unaware of who received Methylene blue (non-peptide stack partner).

Those kept unaware of assignments: investigator and outcomes assessor.

It started in 2019-03-04 with completion listed for 2020-01-15.

It ran at 1 site in Saudi Arabia.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Probing depth (time frame: 12 weeks). Clinical attachment level (time frame: 12 weeks).

It also tracked 4 secondary outcomes, for example Bleeding on probing, Plaque index, Interleukin-6 and Tumor necrosis factor alpha.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Methylene blue (non-peptide stack partner) in 50 people with rheumatoid arthritis.

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, Rheumatoid arthritis research.