NCT04037709

Photodynamic Therapy in Patients With Gingivitis

Completed NA Last updated 11 October 2023

What this trial tests

NA trial testing scaling and root planing (SRP) + PDT placebo in Gingivitis in 20 participants. Completed in 15 March 2022.

Timeline

9 November 2020

Primary endpoint
1 December 2021

15 March 2022

Quick facts

Lead sponsor	University of Nove de Julho
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	20
Start date	9 November 2020
Primary completion	1 December 2021
Estimated completion	15 March 2022
Sites	1 location across Brazil

Drugs / interventions tested

• scaling and root planing (SRP) + PDT placebo
• scaling and root planing (SRP) + PDT

Conditions studied

• Gingivitis — all drugs for Gingivitis →
• Orthodontic Appliance Complication — all drugs for Orthodontic Appliance Complication →
• Photodynamic Therapy — all drugs for Photodynamic Therapy →

Sponsor

University of Nove de Julho

Who can join

Adults 10 to 30, any sex, with Gingivitis or Orthodontic Appliance Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The hypothesis to be tested in this study is whether photodynamic therapy (PDT) could favor the decontamination of these areas, as the photosensitizer and light are capable of reaching areas that these instruments have difficulty accessing. In other words, the objective of this study is to evaluate the impact of PDT as an adjuvant treatment to scaling, considering clinical immunoregulatory in patients with gingivitis with the predisposing factor of the use of a fixed orthodontic appliance. A randomized, controlled, double-blind, split-mouth clinical study will include 17 patients. Patients will have their mouth divided into two groups: Control group (n = 17) - Scaling and Root Planing (SRP) + PDT placebo and Experimental group (n = 17) - SRP + PDT. In G2 will be used methylene blue 0.005%, λ = 660nm, 9J (joule) per inflamed site, irradiance = 3.5W / cm (watts/centimeter), radiant exposure = 318J / cm2. In G1 and G2 the scaling will be performed with the aid of the ultrasound. All participants will receive oral hygiene guidance (OHG) after to the end of the study. The clinical periodontal data to be analyzed: plaque index (PI), gingival index (GI) and probing depth (PD) and clinical level of insertion (CLI) by means of a periodontal probe. Crevicular fluid will be collected (from 8 pre-determined sites) for analysis of the IL-6 (interleukin), IL-1β, IL-8, TNF-α (tumor necrosis factor) and IL-10 cytokines, using the ELISA method.

Publications & conference data

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

1. Efficacy of photodynamic therapy and periodontal treatment in patients with gingivitis and fixed orthodontic appliances: Protocol of randomized, controlled, double-blind study.
   Rosa EP, Murakami-Malaquias-Silva F, Schalch TO, Teixeira DB, et al · · 2020 · cited 9× · PMID 32243363 · DOI 10.1097/md.0000000000019429
2. Evaluation of the effects of photobiomodulation on orthodontic movement of molar verticalization with mini-implant: A randomized double-blind protocol study.
   Murakami-Malaquias-Silva F, Rosa EP, Almeida PA, Schalch TO, et al · · 2020 · cited 3× · PMID 32221067 · DOI 10.1097/md.0000000000019430