Disclosing Agents as Photosensitizers in aPDT for Biofilm Control in Children

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Mechanical Prophylaxis
  Mechanical removal of dental plaque using a Robinson brush at low speed with water, without the use of photosensitizers or light activation.
• Процедура aPDT with Erythrosine
  Application of erythrosine as a photosensitizer followed by blue LED irradiation using a dental curing light to promote antimicrobial photodynamic therapy.
• Процедура 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.

Первичные конечные точки

• Reduction in microbial load of dental biofilm (CFU/mL) [Срок оценки: Baseline and immediately after the intervention]

Вторичные конечные точки (2)

• Clinical feasibility of the protocol [Срок оценки: Baseline and Periprocedural]
• Child behavioral acceptance [Срок оценки: Baseline and Periprocedural]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07539181 · EVIDENCIADORES

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗