Dental Plaque
Conditions
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.
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.
Interventions
PROCEDUREMechanical Prophylaxis
Mechanical removal of dental plaque using a Robinson brush at low speed with water, without the use of photosensitizers or light activation.
PROCEDUREaPDT with Erythrosine
Application of erythrosine as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.
PROCEDUREaPDT 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.
Sponsors
University of Nove de Julho
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single-blind study in which the laboratory outcomes assessor is blinded to group allocation.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 7 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in microbial load of dental biofilm (CFU/mL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical feasibility of the protocol | 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. |
| Child behavioral acceptance | 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. |
Outcome results
None listed