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临床试验/CTRI/2025/09/093999
CTRI/2025/09/093999尚未招募3 期

Comparative evaluation of salivary Streptococcus mutans count after Silver Diamine Fluoride treatment with Glass Ionomer Cement versus Stainless Steel Crown -A Randomized Controlled Trial

未提供1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2025年9月9日最近更新:

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

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Manisha

MAIDS, NEW DELHI

研究点 (1)

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