跳至主要内容
临床试验/CTRI/2020/04/024826
CTRI/2020/04/024826尚未招募不适用

Clinical Evaluation Of Retention Of Pit and Fissure Sealant With and Without SDF/KI Pre-treatment in 6-8Year Old Children – A Randomized Control Trial

Karthika D1 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2020年1月6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
44
试验地点
1
主要终点
Better retention of pit and fissure sealant pre-treated with SDF/KI at baseline, after 3 months and 6 months follow up

研究概览

简要总结

Objective of the study is:

a)      Toevaluate the retention ability of pit and fissure sealant (Ultraseal XT hydro)with SDF/KI pre-treatment in 6-8year old children on primary second molars andfirst permanent molars clinically at baseline, after 3 months and 6 monthsfollow up

b)      Toevaluate the retention ability of pit and fissure sealant (Ultraseal XT hydro)without pre-treatment with SDF/KI in 6-8year old children on primary secondmolars and first permanent molars clinically at baseline, after 3months and 6months follow up

c)      Tocompare the retention ability of pit and fissure sealant (Ultraseal XT hydro)pre-treated with and without SDF/KI

RESEARCHHYPOTHESIS

Pre-treatment with SDF/KI increases theretention ability of Pit and fissure Sealant (Ultraseal XT hydro) at variousintervals of follow up

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor 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

  • Teeth indicated for pit and fissure sealants 2)ICDAS codes 0, 1 and 2 3)Absence of restorations or prior sealants on the teeth under study 4)Absence of cavitated carious lesions.

排除标准

  • Children with special health care needs 2)Teeth with cavitated dentinal caries.

结局指标

主要结局

Better retention of pit and fissure sealant pre-treated with SDF/KI at baseline, after 3 months and 6 months follow up

时间窗: At baseline

次要结局

  • Prevention of Pit and Fissure caries and better retention of pit and fissure sealant pre-treated with and without SDF/KI(After 3 months)

研究者

发起方
Karthika D
申办方类型
Other [No sponsorship]

研究点 (1)

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