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临床试验/NCT02659917
NCT02659917已完成1 期

Performance of Glass-ionomer Cements in the Pit and Fissure Sealing and Atraumatic Restorative Treatment: a Randomized 2-year Clinical Trial

Fernanda Miori Pascon0 个研究点目标入组 147 人开始时间: 2008年8月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
147
主要终点
Number of the teeth with glass-ionomer cement retention and prevention of caries.

研究概览

简要总结

The purpose of this randomized clinical trial was evaluate the performance of two conventional glass-ionomer cements in the pit and fissure sealing and atraumatic restorative treatment in high caries risk children.

详细描述

Sealants were applied on sound permanent first molars by "press finger technique" and carious deciduous molars that required either class I or class II restorations were restored according to manufacturers' recommendations in order to caries prevention and control.

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
Single (Investigator)

入排标准

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

入选标准

  • Volunteers that having at least two permanent first molars of opposite sides of the mouth, erupted in the oral cavity, caries-free and high-risk disease (presence of white spots, history of caries, plaque in smooth surfaces and gingivitis);
  • Children who had one or two bilateral matched pairs of carious deciduous molars that required either class I or class II restorations.

排除标准

  • Children who did not meet the minimum requirements for the achievement of sealants or parents / guardians did not agree to participate;
  • No history of spontaneous pulpal pain.

结局指标

主要结局

Number of the teeth with glass-ionomer cement retention and prevention of caries.

时间窗: 6-month

Criteria established by Frencken et al. (1998) was used.

Number of the teeth with good restoration and caries absence.

时间窗: 6-month

Criteria established by Frencken et al. (1998) was used.

次要结局

  • Frequency of loss of the sealing material and prevention of caries.(6-month)

研究者

发起方
Fernanda Miori Pascon
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Fernanda Miori Pascon

Teacher

University of Campinas, Brazil

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