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临床试验/CTRI/2025/10/095766
CTRI/2025/10/095766尚未招募不适用

Clinical evaluation and comparison of conventional and bioactive pit and fissure sealants in mandibular first permanent molars: a randomized controlled trial

College of Dental Sciences1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2025年10月21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
92
试验地点
1
主要终点
efficacy of bioactive sealant and conventional sealant in pits and fissures to prevent further deterioration of the clinical condition to dental caries

研究概览

简要总结

The purpose of this randomised clinical trial was to compare and evaluate clinical performance of a conventional and a bioactive pit and fissure sealant in terms of sealant retention, marginal adaptation, color changes around sealant and fissure caries in children aged between 6-12 yrs over a 12 month period. A total of 92 fully erupted permanent mandibular 1st molars were selected using a split mouth technique. The sealants were applied under standardised clinical conditions and evaluated at 3, 6 and 12months using modified Cvar and Ryge criteria.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Investigator Blinded

入排标准

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

入选标准

  • Questionable pits and fissures in permanent first molar with age of child ranging from 6 to 10 years.
  • Non-cavitated bilateral deep pit and fissures in molars.
  • Molars with caries-free proximal surfaces.
  • Stained or minimal decalcified appearance of pits and fissures in molars.

排除标准

  • occlusal surface of molars having shallow pit and fissures, which were self cleansing in oral cavity for more than 4years.
  • clinically detectable caries in molars.
  • molars that cannot be isolated adequately or partially erupted molars.
  • previously placed sealants or restorations on molar teeth.

结局指标

主要结局

efficacy of bioactive sealant and conventional sealant in pits and fissures to prevent further deterioration of the clinical condition to dental caries

时间窗: 3months, 6months and 12months

次要结局

未报告次要终点

研究者

发起方
College of Dental Sciences
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Sumedha Kundu Choudhury

College of dental sciences, Davangere

研究点 (1)

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