Not Yet RecruitingNot Applicable

Disclosing Agents as Photosensitizers in aPDT for Biofilm Control in Children

72 participantsStarted 2026-05-31

Plain-language 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.

Who can participate

Age range3 Years – 7 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Timeframe: Baseline and immediately after the intervention

Trial details

NCT IDNCT07539181

SponsorUniversity of Nove de Julho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-30

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