NCT03039244

Evaluation of Antimicrobial Photodynamic Therapy as an Adjunct to Periodontal Treatment in Smokers

Completed NA Last updated 26 October 2017

What this trial tests

NA trial testing Photodynamic therapy in Chronic Periodontitis in 20 participants. Completed in 1 September 2017.

Timeline

1 September 2014

Primary endpoint
1 December 2016

1 September 2017

Quick facts

Lead sponsor	University of Sao Paulo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	20
Start date	1 September 2014
Primary completion	1 December 2016
Estimated completion	1 September 2017
Sites	1 location across Brazil

Drugs / interventions tested

• Photodynamic therapy — full drug profile →
• Control Group — full drug profile →
• Diode Laser

Conditions studied

• Chronic Periodontitis — all drugs for Chronic Periodontitis →

Sponsor

University of Sao Paulo

Who can join

Adults 30 to 60, any sex, with Chronic Periodontitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study proposes to assess the effect of multiple applications of antimicrobial Photodynamic Therapy (aPDT) as an adjunct to non-surgical periodontal treatment (nsPT) in smokers without use of antibiotics. Twenty smokers with a clinical diagnosis of chronic periodontitis will be treated in a split-mouth design study to either aPDT associated with scaling and root planing (SRP) or SRP only. aPDT will be performed by using a laser light source with 690 nm wavelength associated with a phenothiazine photosensitizer. The applications will occur in four episodes (at days 0, 2, 7 and 14). All patients will be monitored for 90 days. Plaque index, probing depth, clinical attachment level and bleeding on probing will be performed at baseline (pre-intervention period) and 30 and 90 days after the (nsPT). Subgingival plaque samples will be collected (at baseline and 30 and 90 days after the nsPT) and the counts of 40 subgingival species will be determined using DNA-DNA checkerboard hybridization. Gingival crevicular fluid samples will be collected (at Day 0, 14, 30 and 90 after the nsPT) and the levels of Interleukin 1 beta, Interleukin 10 and Tumor Necrosis Factor alpha (Luminex) will be evaluated. Salivary cotinine levels will also be evaluated at baseline. Data obtained will be statistically analyzed.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antimicrobial photodynamic therapy as adjunct to non-surgical periodontal treatment in smokers: a randomized clinical trial.
   de Melo Soares MS, D'Almeida Borges C, de Mendonça Invernici M, Frantz FG, et al · · 2019 · cited 20× · PMID 30392080 · DOI 10.1007/s00784-018-2740-3
2. Reporting characteristics of nonsurgical periodontal therapy trials registered in ClinicalTrials.gov: an observational study.
   Stazić P, Jurić D, Turić A, Šošić A, et al · · 2023 · cited 3× · PMID 37418255 · DOI 10.57264/cer-2023-0058