Comparative evaluation of salivary Streptococcus mutans count after Silver Diamine Fluoride treatment with Glass Ionomer Cement versus Stainless Steel Crown -A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- 1. Any change in salivary Streptococcus mutans count after restoration with Glass Ionomer Cement or Stainless Steel Crown in SDF treated primary molars is expected
研究概览
简要总结
This study is a randomized, single-blinded, single-centre trial comparing the salivary Streptococcus mutans count after Silver Diamine Fluoride treatment with Glass Ionomer Cement versus Stainless Steel Crown in 22 children aged 4–8 years, presenting to the Outpatient Department of Pediatric and Preventive Dentistry, MAIDS, New Delhi. Participants will be randomly allocated into two equal groups (n=11) using a single-blinded, simple randomization technique via lottery method. Group 1 will receive SDF application followed by GIC restoration, while Group 2 will receive SDF application followed by SSC restoration. saliva samples will be collected using the drooling technique before, 24 hours, 72 hours and one month post intervention. The need for this study arises from the lack of studies that evaluated the effect of SDF in conjunction with different restorations on S. mutans level in saliva which can provide valuable insights into improving preventive and restorative dental care using SDF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant 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
- •Cooperative children in the age group of 4-8 years.
- •Children with carious primary molar with ICDAS II score 4, 5 and 6, without involving pulp, indicated for SDF and SSC.
排除标准
- •Clinical and radiographic signs of periapical pathology.
- •Children with any Special Health Care Needs or any systemic disease.
- •Children with any dental developmental anomalies or tooth fracture.
- •Children with silver and nickel allergy.
- •Primary molar close to exfoliation (more than 2/3rd root resorption).
- •Children who have received antibiotics two week prior to microbial sampling.
结局指标
主要结局
1. Any change in salivary Streptococcus mutans count after restoration with Glass Ionomer Cement or Stainless Steel Crown in SDF treated primary molars is expected
时间窗: At baseline, 24 hours, 72 hours and 1 month post intervention
次要结局
未报告次要终点
研究者
Dr Manisha
MAIDS, NEW DELHI
