Silver diamine fluoride for caries management in primary molars
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
