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临床试验/NCT03973554
NCT03973554Unknown2 期

Caries Prevention Potential of Pearl Powder Versus Casein Phosphopeptide-amorphous Calcium Phosphate on Enamel White Spot Lesions: Randomized Clinical Trial.

Ruba Alaa El Din Adel El Damarisy0 个研究点目标入组 58 人开始时间: 2019年10月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
58
主要终点
caries prevention in enamel white spot lesion

研究概览

简要总结

to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel white spot lesions.

详细描述

The aim of the study is to evaluate the caries prevention potential of pearl powder against CPP-ACP in enamel White Spot Lesions using laser fluorescence device scoring from 0 to 99, with daily application time of 3 months and follow up period of 6,9,and 12 months.

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
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
12 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • good oral hygiene
  • cooperative patient
  • completion of orthodontic therapy
  • presence of at least two white spot lesions on the labial surface of six maxillary anterior teeth, that were not present before orthodontic treatment

排除标准

  • bad oral hygiene
  • lack of patients compliance
  • allergy to milk products
  • pregnant or lactating women
  • presence of dentin caries, restorations, or enamel hypoplasia on maxillary anterior teeth
  • presence of periodontal pockets around maxillary anterior teeth

研究组 & 干预措施

pearl powder

Experimental

natural product, support bone and joint health

干预措施: pearl powder (Other)

CPP-ACP

Active Comparator

product for professional use containing the active ingredient (CPP-ACP), a special milk-derived protein that has a unique ability to release bio-available calcium and phosphate to tooth surfaces.

干预措施: CPP-ACP (Drug)

结局指标

主要结局

caries prevention in enamel white spot lesion

时间窗: 12 months

caries prevention using laser fluorescence device

次要结局

未报告次要终点

研究者

发起方
Ruba Alaa El Din Adel El Damarisy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ruba Alaa El Din Adel El Damarisy

principal investigator

Cairo University

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