Evaluation of Remineralization Potential of Self Assembling Peptide P11-4 Combined With Fluoride Compared to Fluoride Varnish in Management of Incipient Carious Lesions Using Laser Fluorescence: Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Remineralization
研究概览
简要总结
Self-assembling peptide (P11-4) exhibited an outstanding ability for biomimetic re-mineralization of incipient enamel carious lesions. It creates a 3D matrix within the subsurface of carious lesions, allowing de novo formation of Hydroxyapatite crystals, thus enabling guided enamel regeneration of the demineralized enamel structure. Addition of fluoride to P11-4 may have a synergistic effect on the remineralization potential.
详细描述
This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate remineralization potential of P11-4 combined with fluoride compared to fluoride varnish in management of incipient white spot carious lesions. Progress of the lesions will be assessed using laser fluorescence (DIAGNOdent).
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
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active carious white spot lesions.
- •Patient compliance.
- •Controlled oral hygiene condition.
排除标准
- •Participant in another trial.
- •Non carious lesions.
- •Systemic diseases or concomitant medication affecting salivary flow.
- •Cavitation of carious lesions.
- •Parafunctional habits.
- •Pregnancy.
结局指标
主要结局
Remineralization
时间窗: 6 months
measuring carious lesion development using DIAGNOdent laser fluorescence (scores from 0 to 99) according to progression of the carious lesion
次要结局
未报告次要终点
研究者
Omar Osama Shaalan
Lecturer, Conservative Dentistry Department, Faculty of Dentistry
Cairo University