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临床试验/CTRI/2025/09/094927
CTRI/2025/09/094927尚未招募2/3 期

Comparative Evaluation of 3 Pit And Fissure Sealants (PF Seal, Nanosilver Reinforced and Ultradent XT Hydro) in Permanent Molars Of Children (Age 7-12 Years) A Randomized Control Trial

Dr Vidhi Gopalani1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年9月29日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
colour , presence of caries and anatomic wear

研究概览

简要总结

This study is randomised control trial, parallel group comparing and evaluating the efficacy of 3 pit and fissure sealants in terms of marginal integrity, colour, presence of caries and wear. There will be follow up scheduled after 3 months,6 months 12 months.

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, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
7.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Children of both genders aged 7–12 years with fully erupted permanent molars.
  • 2.Parents who agreed to participate in the study.
  • 3.Presence of sound proximal surfaces of the tooth.

排除标准

  • 1.Patients with bruxism, malocclusion, or allergies to dental resins or latex.
  • 2.Parents who refused to participate in the study.
  • 3.Wide self-cleansing pits and fissures.
  • 4.Presence of proximal caries.
  • 5.Deep caries requiring restoration or deep caries involving the pulp.
  • 6.Children not cooperating for the treatment.

结局指标

主要结局

colour , presence of caries and anatomic wear

时间窗: baseline, 3 months, 6 months, 12 months

次要结局

  • Marginal Integrity(3 months, 6 months, 12 months)

研究者

发起方
Dr Vidhi Gopalani
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Vidhi Gopalani

Hitkarini Dental College and Hospital

研究点 (1)

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