CTRI/2020/01/022962尚未招募Unknown
A Comparative evaluation of efficacy of CPP-ACP varnish with and without papain gel on the remineralisation of white spot lesions using laser fluorescence
King Georges Medical University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2020年1月30日最近更新:
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Change in DIAGNOdent readings of wgite spot lesions
研究概览
简要总结
This study is a randomized, single blind trial comparing the remineralisng efficacy of CPP-ACPF varnish with and without papain gel on white spot lesions using laser fluorescence and Scanning Electron Microscopy (SEM).. A minimum of 66 teeth will be enrolled in the study which will be followed up till 9 months and the primary outcome will be change in diagnodent reading (laser fluorescence) which suggests change in mineral content. The secondary outcome will be qualitative evauation using SEM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Teeth with white spot lesions due to poor oral hygiene prolonged plaque accumulation and teeth undergoing fixed orthodontic treatment.
- •Patients not using any extensive fluoride regimes.
排除标准
- •Teeth with caries activity or periodontal disease Teeth with associated developmental abnormalities like amelogenesis imperfecta, dentinogenesis imperfecta.
- •Teeth with fluorosis.
- •Teeth with hypoplastic white spots.
- •Patients with history of xerostomia.
- •Patients who are on any medications that alter the salivary flow.
- •Patients with hypoplastic enamel defects, cleft lip and palate deformities, orofacial syndrome, other syndromes and multiple restorations on the facial surfaces and patients with a known history of allergy to milk protein.
结局指标
主要结局
Change in DIAGNOdent readings of wgite spot lesions
时间窗: 9 months
次要结局
- Surface changes in enamel using Scanning Electron Microscopy(3 months)
研究者
研究点 (1)
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