Disclosing Agents as Photosensitizers in Antimicrobial Photodynamic Therapy for Biofilm Control in Children Aged 3 to 7 Years: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 72
- 主要终点
- Reduction in microbial load of dental biofilm (CFU/mL)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Single-blind study in which the laboratory outcomes assessor is blinded to group allocation.
入排标准
- 年龄范围
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Mechanical Prophylaxis (Procedure)
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.
干预措施: aPDT with Erythrosine (Procedure)
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.
干预措施: aPDT with GC TriPlaque ID Gel (Procedure)
结局指标
主要结局
Reduction in microbial load of dental biofilm (CFU/mL)
时间窗: 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.
次要结局
- Clinical feasibility of the protocol(Baseline and Periprocedural)
- Child behavioral acceptance(Baseline and Periprocedural)
研究者
Sandra Kalil Bussadori
Principal Investigator
University of Nove de Julho