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临床试验/NCT03187548
NCT03187548Unknown1 期

Evaluation of the Demineralizing Effect on Enamel Surface During Orthodontic Treatment With and Without the Addition of Casein Phosphopeptides-Amorphous Calcium Phosphate (CPP-ACP) on: A Randomized Clinical Trial, Split Mouth Design

Cairo University0 个研究点目标入组 45 人开始时间: 2017年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
入组人数
45
主要终点
Effect on enamel surface color

研究概览

简要总结

This study is aiming in preventing the formation of WSL associated with orthodontic treatment which occurs to more than 50% of orthodontically treated patients through applying CPP-ACP on the enamel surface once every 2 weeks for 3 months.

详细描述

CPP-ACP will be applied on premolars to be extracted in orthodontic patients whose treatment plan indicates extraction of at least 2 premolaes of the maxillary arch. Application will continue on one premolar either the right or left one once every 2 weeks for the first 3 months of the treatment.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • severe crowding
  • Increased overjet
  • Protruded maxillary base
  • Sound maxillary premolars
  • medically free
  • molar classification class II
  • Canine classification class II

排除标准

  • spacing of teeth
  • Decreased overjet
  • Molar classification III Medically compromised patients
  • pregnant females
  • carious premolars
  • hypoplasia

研究组 & 干预措施

CPP-ACP

Experimental

Casein phosphopeptide amorphous calcium phosphate dental paste

干预措施: Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste (Drug)

结局指标

主要结局

Effect on enamel surface color

时间窗: 3 months

Assessment of the effect of CPP-ACP on enamel surface using ICDAS-II

Effect on enamel surface

时间窗: 3 mnths

Assessment of the effect of CPP-ACP on enamel surface using visual analogue scale through digital photograph

次要结局

  • Surface texture(3 months)
  • Microhardnes(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Abd El-Monem Nasr

Doctor

Cairo University

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