Health TrialsbyHealthPanel

Disclosing Agents as Photosensitizers in aPDT for Biofilm Control in Children

ConditionDental Plaque
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-7
SponsorUniversity of Nove de Julho

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mechanical Prophylaxis

    Procedure/Surgery

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

  • aPDT with Erythrosine

    Procedure/Surgery

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

  • aPDT with GC TriPlaque ID Gel

    Procedure/Surgery

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

Treatment groups

72 Participants
are divided into 3 treatment groups
Group A: Mechanical Prophylaxis (Control)Active comparator 1 intervention
Group B: aPDT with ErythrosineExperimental treatment 1 intervention
Group C: aPDT with GC TriPlaque ID GelExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Baseline and immediately after the intervention

Secondary outcomes

1

Clinical feasibility of the protocol

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.

Time frame
Baseline and Periprocedural
2

Child behavioral acceptance

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.

Time frame
Baseline and Periprocedural

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nove de Julho

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: