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临床试验/NCT03235960
NCT03235960Unknown不适用

Clinical Efficacy of Glass-ionomer Fissure Sealants

Association of Paediatric and Preventive Dentists of Serbia1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2004年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
absence of caries

研究概览

简要总结

Despite numerous techniques for enamel protection, occlusal caries still remains a problem. Sealing pits and fissures is considered to be an effective way of preventing caries development. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.

详细描述

Despite numerous techniques for enamel protection, such as topical fluorides, calcium phosphate-based remineralization systems, xylitol, etc., occlusal caries still remains a problem. A carious lesion occurs in pits and fissures of occlusal surfaces primarily due to their specific anatomy, which is considered to be an ideal site for the retention of bacteria and food remnants rendering mechanical means of debridement inaccessible. Sealing pits and fissures is considered to be an effective way of preventing caries development. Today, there is a wide spectrum of available sealing materials. Glass-ionomer cements are mainly recommended for pits and fissures sealing for two reasons. First, they are less susceptible to moisture which allows their use in noncooperable children or in partially erupted teeth where isolation could be a problem, and secondly, due to their potential to act as a fluoride reservoir making enamel more resistant to demineralisation. During last decades, glass-ionomer cements of different physical and chemical properties were used for pits and fissure sealing which probably contributed to variances in their clinical efficacy. The purpose of the study is to clinically examine the caries-preventive effect of a glass-ionomer material for fissure protection in newly erupted permanent molars in children with low, moderate, and high caries-risk.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
5 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • at least one recently erupted permanent molar with sound pits and fissures
  • healthy patients
  • possibility to perform a dental treatment
  • willing to participate in the study

排除标准

  • teeth with an obvious cavity, with a restoration or a sealant completely or partially presented in the fissure system
  • medically compromised patients
  • non cooperative patients
  • not willing to participate in the study

结局指标

主要结局

absence of caries

时间窗: every 12 months during 13 years

absence of caries on sealed tooth surfaces

retention of sealant

时间窗: every 12 months during 13 years

complete or partial retention

次要结局

未报告次要终点

研究者

发起方
Association of Paediatric and Preventive Dentists of Serbia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dejan Markovic

professor

Association of Paediatric and Preventive Dentists of Serbia

研究点 (1)

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