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临床试验/NCT03628729
NCT03628729Unknown不适用

Investigation of the Incidence of Caries in Pits and Fissures Sealed With Bioactive Sealant

Cairo University0 个研究点目标入组 80 人开始时间: 2018年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
80
主要终点
caries incidence

研究概览

简要总结

This study will be conducted to investigate the incidence of caries in pits and fissures sealed with a bioactive sealant compared to a fluoride releasing resin based pits and fissures sealant in preventive treatment procedures in adult population over a six months period.

详细描述

The study will be conducted in Conservative Dentistry Department, Faculty of Dentistry, Cairo University, The operator in charge will be: Mohamed Tarek Heiba. The researcher will bear ultimate responsibility for all activities associated with the conduct of a research project including recruitment of patients, explaining and performing the procedures to them,A total of 40 volunteer patients with at least 2 non-cavitated molar teeth will be assigned in this study. Patients will be randomly divided into two groups according to type of sealant (S) where in group S1, pits and fissures will be sealed with bioactive pits-and-fissure sealant; while group S2, pits and fissures will be sealed with fluoride releasing resin based pits and fissures sealant. Each restoration will be assessed after three, six months,The tooth will be illuminated with a violet light approximately 405 nm thus stimulating both prophyrins to emit red light that contains less energy. the denser the bacteria colonization on tooth's surface, the more intense the red fluorescent signal; in contrast sound enamel sent out a green fluorescent signal. These light signals are recorded by the highly developed optics and analyzed by the device's software. The software filters and quantifies the fluorescence emitted by the dental tissue and converts the relationship between green and red.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients should be 16-25 Years old
  • Patient should have good oral hygiene and general health with at least 2 •sound intact occlusal surfaces of first and/or second molar teeth in each quadrant of maxilla or mandible.

排除标准

  • Known allergy to any of the resins used
  • Clinically detectable caries
  • Previously placed sealants or restorations
  • Bruxism or malocclusion

研究组 & 干预措施

Embrace™ WetBond™ Pit & Fissure Sealant.

Experimental

pits and fissures will be sealed with bioactive pits-and-fissure sealant

干预措施: Embrace™ WetBond™ Pit & Fissure Sealant (Other)

Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA

Active Comparator

Pits and fissures will be sealed by fluoride releasing resin based pits and fissures sealant

干预措施: Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA (Other)

结局指标

主要结局

caries incidence

时间窗: six months

development of pit and fissure caries

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed tarek heiba

Master student

Cairo University

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