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临床试验/NCT04272866
NCT04272866Unknown不适用

Comparing the Bond Strength,Microleakage and the Clinical Performance of Three Different Pit and Fissure Sealants (An in Vitro,in Vivo Study)

Sarah Emad Ali El-Din1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年7月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Retention of the sealants

研究概览

简要总结

The aim of the study is :-

  1. To evaluate and compare the microleakage of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro.
  2. To evaluate and compare the bond strength of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer Fuji Triage sealant) in vitro.
  3. To clinically evaluate and compare the retention of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer-based Fuji Triage sealant).
  4. To clinically evaluate and compare the caries prevention effect of three different fissure sealants(resin-based Clinpro sealant, Moisture tolerant resin-based Embrace WetBond sealant and glass ionomer-based Fuji Triage sealant).

详细描述

Total of 60 first permanent molar in male and female children aged between 6-9 years included in this prospective study will be selected randomly from the outpatient Pediatric Dentistry and Dental Public Health Department Faculty of Dentistry Ain Shams University.

Informed consent will be signed for each case by the patient's parent or guardian after thorough explanation of the study.

Procedural Steps:

In vivo

  1. Teeth will be divided equally into 3 groups randomly according to the type of sealant used.
  2. Pit and fissure sealant application will be conducted by a single operator.
  3. A thorough oral prophylaxis of both upper and lower arches was done, followed by polishing using a slurry of pumice and rotating brush to ensure removal of debris from fissures.
  4. The occlusal surfaces were then thoroughly cleaned with water to remove all traces of pumice. Isolation of permanent first molars will be obtained using cotton rolls and a saliva ejector.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
6 Years 至 9 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •1- First permanent molars fully erupted with deep and retentive fissures,free of caries and free of any periapical radiolucency.
  • •2- Males and Females 3- Age group between 6-9 years 4- Medically free 5- High caries risk children

排除标准

  • •Medically compromised children
  • •Uncooperative children.
  • •Children with abnormalities in occlusion
  • •children with abnormal oral habits

研究组 & 干预措施

Group 1

Active Comparator

Teeth in this group will be sealed with clinpro sealant

干预措施: Clinpro sealant (Other)

Group2

Experimental

Teeth in this group will be sealed with embrace wetbond sealant

干预措施: Embrace wetbond sealant (Other)

Group3

Experimental

Teeth in this group will be sealed with triage sealant

干预措施: Triage sealant (Other)

结局指标

主要结局

Retention of the sealants

时间窗: 6 months

Retention of the sealants will be evaluated according to modified Simon's criteria

Caries prevention effect of the sealants

时间窗: 6 months

Caries prevention effects will be evaluated according to modified Simon's criteria

次要结局

未报告次要终点

研究者

发起方
Sarah Emad Ali El-Din
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sarah Emad Ali El-Din

Instructor at pediatric dentistry department faculty of dentistry ain shams university

Ain Shams University

研究点 (1)

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