Antimicrobial Methylene Blue Photodynamic Therapy Versus Conventional Prophylaxis for Preventing Recurrent Chromogenic Stains on Deciduous Teeth: A Pilot Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Recurrence of Chromogenic Extrinsic Stains
研究概览
简要总结
Chromogenic extrinsic stains are common in children and frequently recur following conventional prophylaxis. Antimicrobial photodynamic therapy (aPDT) using methylene blue activated by red light has demonstrated antimicrobial activity against oral biofilm and may reduce stain recurrence. This pilot controlled clinical trial aims to compare conventional prophylaxis combined with methylene blue-mediated antimicrobial photodynamic therapy with conventional prophylaxis alone for preventing recurrent chromogenic extrinsic stains on deciduous teeth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The clinical examiner responsible for outcome assessment will be blinded to the participant's treatment allocation throughout the study.
入排标准
- 年龄范围
- 4 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 4 to 6 years with chromogenic extrinsic stains affecting deciduous teeth.
- •Medically healthy children (ASA I or II).
- •Children with cooperative behavior suitable for routine dental treatment.
- •Parent or legal guardian willing to provide written informed consent.
- •Ability to attend all scheduled follow-up visits.
排除标准
- •Known allergy or hypersensitivity to methylene blue.
- •Photosensitivity disorders or current use of photosensitizing medications.
- •Extensive untreated dental caries or acute dental infection requiring emergency treatment.
- •Gingival or periodontal conditions that interfere with clinical assessment.
- •Iron-associated extrinsic staining.
- •Children unable to comply with study procedures or follow-up visits.
结局指标
主要结局
Recurrence of Chromogenic Extrinsic Stains
时间窗: 6 months after treatment
Recurrence of chromogenic extrinsic stains assessed by standardized clinical visual examination and recorded as the presence or absence of visible chromogenic extrinsic staining at the 6-month follow-up visit.
次要结局
- Complete Stain Removal Assessed by Standardized Clinical Examination(Immediately after treatment)
- Parent/Guardian Satisfaction Assessed Using a Study-Specific 5-Point Likert Satisfaction Questionnaire(Immediately after treatment and at 6 months)
研究者
Maram Gomaa Gebaly Oraby
Pediatric Dentistry Resident
Cairo University