跳至主要内容
临床试验/CTRI/2026/01/101557
CTRI/2026/01/101557尚未招募不适用

Comparative evaluation of retention of silver nanoparticles infused pit and fissure sealant with conventional pit and fissure sealant in permanent first molars an in vivo study

Dr Akashdeep Singh1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2026年2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
45
试验地点
1
主要终点
The retention rate of the pit and fissure sealants will be assessed.

研究概览

简要总结

STUDY DESIGN • Double-blinded study will be done using split mouth design.

• Evaluation will be done by a single trained and calibrated examiner who will be blinded to tooth allocation.

Total of 90 permanent first molars from 45 children aged 6-10 years will be selected based on the following inclusion and exclusion criteria.

INCLUSION CRITERIA • Healthy cooperative patients. • Fully erupted Permanent first molars with deep pit and fissures. • Permanent first molars with International Caries Detection and Assessment System (ICDAS) scores 0, 1 and 2 will be included. • Permanent first molars with no previous restorations.

EXCLUSION CRITERIA • Uncooperative patients. • Mentally challenged patients. • Physically disabled patient. • Patient diagnosed with ICDAS 03 or above. • Permanent first molars with previously restored pit and fissures.

METHODOLOGY SAMPLE DISTRIBUTION Randomization will be carried out by toss of coin to allocate the selected molars into two equal groups

Group 1 (n=45): Pit and fissure on occlusal surface of Permanent first molars to be sealed with Silver nanoparticles infused pit and fissure sealant (e-Pit & Fissure Sealant by Kids-e-Dental Mumbai, India)

Group 2 (n=45): Pit and fissure on occlusal surface of Permanent first molars to be sealed with conventional pit and fissure sealant (Helioseal F Plus by Ivoclar Vivadent, Newyork, USA)

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 Outcome Assessor 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

  • Healthy cooperative patients.
  • Fully erupted Permanent first molars with deep pit and fissures.
  • Permanent first molars with International Caries Detection and Assessment System (ICDAS) scores 0, 1 and 2 will be included.
  • Permanent first molars with no previous restorations.

排除标准

  • Uncooperative patients.
  • Mentally challenged patients.
  • Physically disabled patient.
  • Patient diagnosed with ICDAS 03 or above.
  • Permanent first molars with previously restored pit and fissures.

结局指标

主要结局

The retention rate of the pit and fissure sealants will be assessed.

时间窗: at baseline, 3, 6, 9 and 12 months

次要结局

  • Incidence of caries on occlusal surface.(Incidence of caries on occlusal surface will also be assessed at 3, 6, 9 and 12)

研究者

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

Dr Nitika Bajaj

Dashmesh institute of research and dental sciences

研究点 (1)

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