Disclosing Agents as Photosensitizers in aPDT for Biofilm Control in Children

April 13, 2026 updated by: Sandra Kalil Bussadori, University of Nove de Julho

Disclosing Agents as Photosensitizers in Antimicrobial Photodynamic Therapy for Biofilm Control in Children Aged 3 to 7 Years: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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. Dental biofilm is a major etiological factor for dental caries, especially in pediatric populations, and alternative strategies for its control are relevant in minimally invasive dentistry. A total of 72 children will be randomly allocated into three parallel groups (n = 24 per group): (1) mechanical prophylaxis (control group), (2) aPDT using erythrosine as a photosensitizer, and (3) aPDT using GC TriPlaque ID Gel as a photosensitizer. In the experimental groups, the photosensitizer will be applied to the dental surface followed by blue light-emitting diode (LED) irradiation using a dental curing light. In the control group, only mechanical prophylaxis will be performed using a Robinson brush at low speed with water. Dental biofilm samples will be collected from the cervical vestibular surface of primary molars before and immediately after the intervention. Microbiological analysis will be performed to quantify colony-forming units per milliliter (CFU/mL), allowing the evaluation of antimicrobial effectiveness. Secondary outcomes include clinical feasibility, assessed by the duration of the procedure using a stopwatch, and behavioral acceptance, evaluated using the Frankl Behavior Rating Scale. The study is designed as a single-blind trial, in which the outcomes assessor is blinded to group allocation.

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Mechanical Prophylaxis (Control)
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
Mechanical removal of dental plaque using a Robinson brush at low speed with water, without the use of photosensitizers or light activation.
Other Names:
  • Dental cleaning
Experimental: aPDT with Erythrosine
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
Application of erythrosine as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.
Other Names:
  • Antimicrobial photodynamic therapy with erythrosine
Experimental: aPDT with GC TriPlaque ID Gel
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
Application of GC TriPlaque ID Gel as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.
Other Names:
  • Antimicrobial photodynamic therapy with GC TriPlaque ID Gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction in microbial load of dental biofilm (CFU/mL)
Time Frame: Baseline and immediately after the intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical feasibility of the protocol
Time Frame: Baseline and Periprocedural
Assessment of the total duration of the clinical procedure, measured in minutes using a stopwatch from the beginning to the end of the intervention, to evaluate the feasibility of the protocol in pediatric patients.
Baseline and Periprocedural
Child behavioral acceptance
Time Frame: Baseline and Periprocedural
Behavioral response of children during the clinical procedure assessed using the Frankl Behavior Rating Scale (scores 1 to 4), evaluating cooperation and acceptance of the treatment.
Baseline and Periprocedural

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nove de Julho

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 31, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

April 7, 2026

First Submitted That Met QC Criteria

April 13, 2026

First Posted (Actual)

April 20, 2026

Study Record Updates

Last Update Posted (Actual)

April 20, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVIDENCIADORES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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