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临床试验/NCT03034837
NCT03034837已完成4 期

Economic Evaluation of ART Sealant in Preventing Pit and Fissure Caries in Permanent First Molars in an Asia Population

Zhengzhou University2 个研究点 分布在 1 个国家目标入组 329 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
329
试验地点
2
主要终点
cost-effectiveness of sealing

研究概览

简要总结

Eruption of the first permanent molar is the earliest in our oral cavity, leading to a high occurrence of dental caries in its pits and fissures. Early prevention of pit and fissure caries in this tooth is therefore of great importance for the preservation of a healthy dentition in one's life long time.

It has been shown that sealing the occlusal surface with pit and fissure sealant is a highly effective method to prevent pit and fissure caries. It has also been shown that the performance of sealing pits and fissures by glass ionomer materia l (the high viscosity, classification type 2 GIC material) using finger press method used in the atraumatic restoration method is as significant as that of using the traditional resin sealant material and technique.

The purpose of this study is to evaluate the long-term cost-effectiveness performance of the two sealing materials in the prevention of pits and fissures caries in young permanent molars of schoolchildren in a dental public health program to be held in primary schools. The findings will provide valuable information for decision making on the election of proper material and method for use in dental public program, especially for child population in the rural or social-economically deprived areas.

详细描述

Primary school children will be recruited and cluster randomized into three groups. Baseline dental check-up will be conducted to all the recruited children and dental status will be recorded. Placement of resin sealant or sealant using the glass ionomer material to the eligible permanent first molars or providing of oral health education will be interventions to the three groups respecively according to the group allocation. All the interventions will be provided only once in this study, and the children will be followed for at least 24 months at an six month interval to motor the dental caries of the included permanent first molars. Cost-effectiveness of placement of resin sealant and glass ionomer sealant will be evaluated and reported.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Investigator)

入排标准

年龄范围
7 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • generally healthy grade 1-2 school children
  • with written parental consent
  • with at least 1 sound and fully erupted permanent first molar

排除标准

  • Can not cooperate with the treatment
  • Can not obtain the child's parental consent

研究组 & 干预措施

Resin sealant

Active Comparator

Sealing pit and fissures of the included permanent first molars using "SDI conseal f" resin sealant material once at the baseline of the study.

干预措施: resin sealant (Drug)

ART sealant

Experimental

Sealing pit and fissures of the included permanent first molars using "3M ESPE KetacTM Molar Easymix" glass ionomer cement material once at the baseline of the study.

干预措施: ART sealant (Drug)

结局指标

主要结局

cost-effectiveness of sealing

时间窗: 24-month

the incrental cost-effectiveness ratio of different sealing material used in this study in preventing pit and fissure caries in the permanent molars.

次要结局

未报告次要终点

研究者

发起方
Zhengzhou University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Liu Baoying

Dr.

Zhengzhou University

研究点 (2)

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