CTRI/2024/01/062040尚未招募4 期
Comparative evaluation of retention of pit and fissure sealant with and without application of 38% silver diamine fluoride in 6-8 year old children: An in-vivo study
VSPM Dental college and Research centre1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月2日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To evaluate and compare the retention of pit and fissure sealant with and without application of 38% silver diamine fluoride
研究概览
简要总结
This study is to evaluate retention of pit and fissure sealant with application of 38% silver diamine fluoride which is supposed to arrest caries in 6 - 8 year old children. Silver diamine fluoride tends to increase the retention of pit and fissure sealant. This study will also evaluate if there is any color change after application of silver diamine fluoride and whether the parents will accept the discoloration in their child.
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 and Investigator Blinded
入排标准
- 年龄范围
- 6.00 Year(s) 至 8.00 Year(s)（—）
- 性别
- All
入选标准
- •1.6-8 years old healthy child
- •DMF of the child.
- •ICDAS scoring.
- •1 in erupted 1st permanent molar
- •Absence of restoration/prior sealant on the tooth
- •No prior dental therapy
- •With written informed consent from parent.
排除标准
- •Medically compromised patients with history of respiratory disease, mentally and physically challenged patients
- •Long term regimen of medication for dental pain.
- •History of adverse reaction to any of the restorative materials used.
- •Radiographic radiolucency associated with respective tooth
- •Highly uncooperative child.
结局指标
主要结局
To evaluate and compare the retention of pit and fissure sealant with and without application of 38% silver diamine fluoride
时间窗: To evaluate and compare the retention of pit and fissure sealant with and without application of 38% silver diamine fluoride at postoperative, 1 month, 3 month and 6 months.
次要结局
- To analyze the color change of pit and fissure sealant after application of 38% silver diamine fluoride.(To assess parental acceptance of discoloration if any, in study group)
研究者
研究点 (1)
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