NCT05805761

Antimicrobial Photodynamic Therapy With Erythrosine and Blue Light on Dental Biofilm Bacteria

Status unknown Phase 1, PHASE2 Last updated 3 August 2023

What this trial tests

Phase 1, PHASE2 trial testing Conventional Treatment in Dental Plaque in 30 participants. Status unknown.

Timeline

20 August 2023

Primary endpoint
20 November 2023

20 December 2023

Quick facts

Lead sponsor	University of Nove de Julho
Phase	Phase 1, PHASE2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	20 August 2023
Primary completion	20 November 2023
Estimated completion	20 December 2023

Drugs / interventions tested

• Conventional Treatment — full drug profile →
• Antimicrobial Photodynamic Therapy

Conditions studied

• Dental Plaque — all drugs for Dental Plaque →

Sponsor

University of Nove de Julho

Who can join

Adults 18 to 30, any sex, with Dental Plaque. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to investigate the effect of Antimicrobial Photodynamic Therapy mediated by Erythrosine and blue LED in the reduction of bacteria in dental biofilm. This clinical trial will be carried out with 30 patients who have biofilm, but without the presence of periodontal pockets, and who are being treated at the Dental Clinic of Universidade Metropolitana de Santos. A split-mouth model will be used (n = 30), with group I control - conventional treatment and group II - conventional treatment and antimicrobial photodynamic therapy (aPDT). The bicarbonate jet will be used to remove dental biofilm in both groups. The treatment will be carried out in 1 session. aPDT will be performed before cleaning/prophylaxis, only in group II. Participants will rinse with the photosensitizer erythrosine (diluted to 1mM) for 1 min of pre-irradiation time, so that the drug can stain all the bacterial biofilm. Then, the D-2000 LED (DMC) will be applied, emitting at a wavelength of ʎ = 430-490 nm and 900-1100 mW/cm2. Irradiation will be performed until the biofilm of the cervical region is illuminated for 2 min per point. Each irradiation point will be approximately 0.4 cm2. The microbiological examination will be performed from samples of supragingival biofilm collected from the gingival sulcus. Two collections will be performed in each experimental site before irradiation, and immediately after the irradiation procedure (group II) or prophylaxis (groups I and II). Biofilm samples will be collected before and after exposure, respectively, and sent to the microbiological laboratory for colony counting. After this period, the CFU's will be counted and the data will be submitted to statistical analysis for comparison of pre and post-treatment results and between groups (conventional X aPDT).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Antimicrobial photodynamic therapy with erythrosine and blue light on dental biofilm bacteria: study protocol for randomised clinical trial.
   Gonçalves MLL, Sobral APT, Gallo JMAS, Gimenez T, et al · · 2023 · cited 10× · PMID 37730405 · DOI 10.1136/bmjopen-2023-075084