Effect of Antimicrobial Photodynamic Therapy on Deep Caries in Permanent Tooth: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quantification of bacteria by colony counting
研究概览
简要总结
The aim of this study is to assess the clinical effect of aPDT on deep caries in permanent teeth. Half of the deep caries will receive aPDT disinfect in restorative treatment procedure, while the other half will receive sodium 0.9% saline in restorative treatment procedure.
详细描述
The aim of the proposed study is to assess the clinical effect of antimicrobial photodynamic therapy (aPDT) using LED on dentin with deep caries in permanent teeth. Permanent teeth with deep carious lesions on the occlusal surface indicated for restorative treatment will be randomly allocated to two groups: Group 1 -Control after incomplete caries removal, washed with sodium 0.9% saline; Group 2 - PDT + CH after incomplete caries removal, disinfect the residual dentin with PDT(LED + O-Toluidine Blue). Dentin samples will be collected before and after disinfect for microbiological analysis. Then the teeth will be capped with CH and restored using resin with clinical and radiographic follow up at 6, 12 and 24 months.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Good general health, without syndromes or chronic systemic diseases
- •Permanent tooth with deep carious lesion (2/3 of dentin) without pain symptomatology and compatible with reversible pulpits
排除标准
- •Refused to sign the informed consent document
- •Allergic to photosensitizer
- •Unlikely to be able to comply with the study procedures
结局指标
主要结局
Quantification of bacteria by colony counting
时间窗: 2 days after dentin collection
Quantification of total bacteria
次要结局
- Tooth Pain(1 day and 6, 12, 24 months)
- Restoration Quality(1 day and 6, 12, 24 months)
研究者
Xiaojing Huang
DDS, PhD, Professor，Vice Dean，School and Hospital of Stomatology Fujian Medical University
Fujian Medical University