Effectiveness of Self-assembling Peptide (P11-4) and Nano-silver Fluoride Varnish in Management of Enamel White Spot Lesions in Young People (Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in the activity status of lesions scored using ICDAS-LAA
研究概览
简要总结
Background: Great efforts have been undertaken for dental caries prevention. Among the recent remineralizing materials, Nano silver fluoride varnish products which are based on nanotechnology have been proposed for "repairing" enamel . Regenerative medicine-based approaches for caries treatment focus on biomimetic remineralization of initial carious lesions as a minimal invasive therapy using Self-Assembling Peptide P11-4 (Curodont Repair) which enhances remineralization of white spot lesions. Purpose of the Study: The aim of this study is to compare clinically and microbiologically the therapeutic effect of Self Assembling Peptide P11-4 (Curodont Repair), nano silver fluoride varnish and 5% fluoride varnish (Duraflor) on remineralization of enamel White Spot Lesions in permanent teeth of adults.
详细描述
The study will be a randomized controlled double-blinded study conducted on participants aged 10 to 24 years satisfying the inclusion criteria with visible active white spot lesions on buccal surfaces of permanent teeth. Sixty six patients will be randomly allocated into 3 groups of the three materials: study group 1: one application of Curodont Repair, study group 2: one application of Nano-silver fluoride varnish and Control group twice application of Fluoride Varnish (Duraflor).
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 (Participant)
入排标准
- 年龄范围
- 10 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1- An age range of 10-24 years ( age of young adolescents and youth as described by the WHO was selected (WHO, 2019).
- •The presence of at least one visible WSL in the buccal surface of permanent teeth with ICDAS II score of 1, or
- •Completion of an informed consent to participate in the study
排除标准
- •Patients receiving the following medications: tetracyclines, any other medication known to stain teeth or any medication causing dry mouth and/or limiting salivary flow.
- •Patients receiving any antibiotic within 1 month prior to each saliva sample collection
- •Selected tooth with microcavities or dentinal involvement due to loss of enamel tissues.
- •Selected tooth with a restoration adjacent to the lesions to avoid false- positive readings.
- •Selected tooth with fluoride application < 3 months prior to study treatment.
- •Selected tooth with discolouration, enamel hypoplasia or fluorosis.
- •Patients with multiple cavitations to avoid variability in microbiological analysis.
结局指标
主要结局
Change in the activity status of lesions scored using ICDAS-LAA
时间窗: 12 months
Change in the activity status of lesions scored using ICDAS-LAA from baseline to final follow up.
次要结局
- Microbial count of mutans streptococci, lactobacilli.(6 months)
- Change in mean DIAGNOdent readings.(12 months)
研究者
Hams Hamed Abdelrahman
Assistant lecturer
Alexandria University