Disclosing Agents as Photosensitizers in aPDT for Biofilm Control in Children

NCT07539181 | Not Yet Recruiting

• 1 other identifier: EVIDENCIADORES
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

This randomized controlled clinical trial aims to evaluate the effectiveness of plaque disclosing agents used as photosensitizers in antimicrobial photodynamic therapy (aPDT) for the control of dental biofilm in children aged 3 to 7 years. Participants will be allocated into groups to receive different treatment protocols, and biofilm levels will be assessed before and after the interventions. The primary outcome is the reduction of dental biofilm, aiming to determine whether disclosing agents can be an effective alternative photosensitizer in aPDT for pediatric patients.

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

• Reduction in microbial load of dental biofilm (CFU/mL)

  Quantitative analysis of colony-forming units (CFU/mL) in dental biofilm samples collected from the cervical vestibular surface of primary molars to assess microbial load reduction after intervention. Samples will be obtained before and after treatment and processed for microbiological evaluation.

  Baseline and immediately after the intervention

Secondary Outcomes (2)

• Clinical feasibility of the protocol

  Baseline and Periprocedural

• Child behavioral acceptance

  Baseline and Periprocedural

Study Arms (3)

Mechanical Prophylaxis (Control)

ACTIVE COMPARATOR

Participants will receive mechanical prophylaxis using a Robinson brush at low speed with water, without the use of photosensitizers or blue LED irradiation.

Procedure: Mechanical Prophylaxis

aPDT with Erythrosine

EXPERIMENTAL

Participants will receive antimicrobial photodynamic therapy (aPDT) using erythrosine as a photosensitizer followed by blue LED irradiation. Mechanical prophylaxis will be performed after post-intervention sample collection.

Procedure: aPDT with Erythrosine

aPDT with GC TriPlaque ID Gel

EXPERIMENTAL

Participants will receive antimicrobial photodynamic therapy (aPDT) using GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation. Mechanical prophylaxis will be performed after post-intervention sample collection.

Procedure: aPDT with GC TriPlaque ID Gel

Interventions

Mechanical Prophylaxis PROCEDURE

Mechanical removal of dental plaque using a Robinson brush at low speed with water, without the use of photosensitizers or light activation.

Also known as: Dental cleaning

Mechanical Prophylaxis (Control)

aPDT with Erythrosine PROCEDURE

Application of erythrosine as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.

Also known as: Antimicrobial photodynamic therapy with erythrosine

aPDT with Erythrosine

aPDT with GC TriPlaque ID Gel PROCEDURE

Application of GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.

Also known as: Antimicrobial photodynamic therapy with GC TriPlaque ID Gel

aPDT with GC TriPlaque ID Gel

Eligibility Criteria

• Age: 3 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 3 to 7 years
• Both sexes
• Good general health status
• Classified as high caries risk according to the CAMBRA protocol (score ≥ +4 or presence of at least one disease indicator associated with two or more biological risk factors)
• Written informed consent obtained from a parent or legal guardian

You may not qualify if:

• Presence of systemic diseases
• Use of antibiotics within the last 30 days
• Use of antimicrobial mouthwash within 48 hours prior to sample collection
• Presence of structural dental alterations that may interfere with the standardization of the procedure
• Uncooperative behavior preventing safe clinical examination and intervention

Sponsors & Collaborators

• University of Nove de Julho: lead

MeSH Terms

Conditions

Dental Plaque

Interventions

Erythrosine

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind study in which the laboratory outcomes assessor is blinded to group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to three parallel groups: mechanical prophylaxis (control), antimicrobial photodynamic therapy (aPDT) with erythrosine, and aPDT with GC TriPlaque ID Gel. Microbiological outcomes will be assessed before and after the interventions.

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 20, 2026
• Study Start (Estimated): May 31, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-04