跳至主要内容
临床试验/CTRI/2024/03/064553
CTRI/2024/03/064553尚未招募2/3 期

Comparative evaluation of Remineralizing Potential of Acidified Caesin Phosphopeptide Amorphous Calcium Phosphate Fluoride and Acidulated Phosphate Fluoride on early enamel carious lesion -A Randomized Controlled Trial

Dr Sasidharan S1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年4月15日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Reversal of early enamel lesion evaluated through ICDAS scores

研究概览

简要总结

The early carious lesions categorized with ICDAS scores 1 & 2 in the dentition of 6 years and above age group children will be recruited and one group will be treated with Acidified CPP-ACPF gel (study group) and the other with conventional APF gel (comparator group). Upon 6th month and 1 year of observation, the early carious lesion reversal is observed and recorded to see the remineralisation efficiency of the test and control agents.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Outcome Assessor Blinded

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Subjects with ICDAS II code 1
  • Those who have high caries prevalence experience.

排除标准

  • Those with systemic disease
  • Those with special care needs children.
  • Caries with ICDAS II code more than
  • Those who don’t give consent to participate.

结局指标

主要结局

Reversal of early enamel lesion evaluated through ICDAS scores

时间窗: Reversal of early enamel lesion evaluated through ICDAS scores at month 6 and 12

次要结局

  • DMFS(6 and 12 month)

研究者

发起方
Dr Sasidharan S
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Rahmath Meeral P

Saveetha Dental College and Hospital

研究点 (1)

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