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临床试验/CTRI/2020/07/026877
CTRI/2020/07/026877已完成不适用

Silver diamine fluoride for caries management in primary molars

ESIC Dental College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2020年1月8日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
Clinical and radiological success of silver diamine fluoride in deep carious lesions

研究概览

简要总结

The study was conducted in the Department of Pediatric & Preventive Dentistry, ESIC Dental College, Rohini, Delhi. Children in the age group of 4-8 years, presenting to the departmental clinic for dental treatment were screened, and those presenting clinically cavitated carious lesion involving dentin having soft caries in primary molar without pulp exposure were considered for participation in the study. Informed consent was obtained from each subject’s parents before enrolling them in study. Each child was randomly assigned to treatment group A or B by envelope method.

The two groups divided were as follows:   a)  GROUP-A : (n=25) Control- Complete caries removal done and tooth restored with Stainless steel crown (SSC)

b)  GROUP-B: (n=25) Silver diamine fluoride applied followed by SSC using Hall technique.                          Follow up was done at 1 month, 3,6,12 months interval and treatment success or failure was determined by a combination of clinical and radiographic findings by an investigator blinded to the treatment groups. Radiographs were taken at 3months, 6 months and 12 months follow up visit. The differences in both the groups for clinical and radiographic parameters was statistically analysed- qualitative data using chi square test.

Results: Combining clinical and radiological results for major failures, there was no statistically significant difference in both the groups.

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
4.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • Healthy cooperative dental patients presenting cavitated carious lesions involving dentin without pulp exposure in primary molars.

排除标准

  • History of spontaneous pain/ presence of abscess or fistula or abnormal mobility/ radiographic evidence of internal root resorption or peri-apical pathosis.

结局指标

主要结局

Clinical and radiological success of silver diamine fluoride in deep carious lesions

时间窗: 1 month, 3 months, 6 months, 12 months

次要结局

未报告次要终点

研究者

发起方
ESIC Dental College
申办方类型
Government medical college

研究点 (1)

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