跳至主要内容
临床试验/CTRI/2025/09/094025
CTRI/2025/09/094025尚未招募不适用

Comparative evaluation of fluoride release of four restorative materials and their rechargeability using three topical fluoride agents an in vivo and in vitro study

Bhagya S Kumar1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年11月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
160
试验地点
1
主要终点
the flouride content in the salive is measured

研究概览

简要总结

This study examines the fluoride release and rechargeability of dental restorative materials important for long-term caries prevention. We will evaluate four materials (Type 2 GIC, Zirconia-reinforced GIC, Giomer, UDMA-based material) and three topical fluoride agents in in-vitro and in-vivo conditions. In-vitro analysis will track fluoride release and post-recharge effects. In-vivo, 160 children will be restored using the best in-vitro material, with salivary fluoride measured at specified intervals. Our goal is to identify the best-performing materials and agents, thereby offering evidence-based recommendations for pediatric dental care.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
8.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • children with a single decayed tooth in the oral cavity will be included, participants should be healthy with no prior exposure to topical fluoride (e.g., fluoride gels or varnish) or systemic fluoride.

排除标准

  • those with multiple restored teeth or requiring multiple restorations will be excluded.
  • Medically compromised children and those undergoi ng orthodontic treatment will be excluded.

结局指标

主要结局

the flouride content in the salive is measured

时间窗: base line flouride concentration is measured before the study and after intervention flouride levels in saliva is measured on day 1,15 and 30

次要结局

  • decreased caries incidence in adjacent teeth or reduced rate of recurrent caries in the present tooth(1 year)

研究者

发起方
Bhagya S Kumar
申办方类型
Other [self sponsored study]
责任方
Principal Investigator
主要研究者

Dr Bhagya S Kumar

Department of Pediatric and Preventive Dentistry

研究点 (1)

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