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临床试验/NCT01446107
NCT01446107已完成不适用

A Randomized Controlled Trial on the Effectiveness of Fissure Sealant and Topical Fluoride Application in Preventing Dental Caries

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 502 人开始时间: 2007年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
502
试验地点
1
主要终点
dental caries

研究概览

简要总结

Nearly half of the 12-year-old children in China have dental caries (tooth decay) and most of the lesions are in the fissures of the first permanent molars. This study aims to investigate the effectiveness of three methods in preventing fissure caries in permanent teeth in Chinese children, namely resin fissure sealant, sodium fluoride varnish, and silver diamine fluoride solution. The cost-effectiveness of these methods will also be compared. About 400 children, aged 8 to 9 years, will be recruited. Clinical examination of the children will be conducted in school using portable dental lights and instruments to identify teeth that need caries prevention. The children will be randomly allocated to one of the three test or the control groups. Treatments will be provided in the study primary schools according to standard clinical protocols. Follow-up examinations will be carried out every six months for 30 months to assess whether the preventive methods are successful, i.e. no dental caries develops in the treated teeth. The findings of this study will be of great value to dentists and public health authorities in deciding on the most appropriate dental caries prevention programme for school children in China and other developing countries.

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, Care Provider, Outcomes Assessor)

入排标准

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

入选标准

  • •school children in good general health
  • •have at least one permanent first molars that has deep occlusal fissures, or fissures with signs of early caries

排除标准

  • •children with major systemic disease or taking long-term medications
  • •not cooperative or refuse dental treatments

研究组 & 干预措施

fissure sealant

Experimental

single placement of resin fissure sealant on tooth surface

干预措施: placement of fissure sealant (Other)

fluoride varnish

Experimental

application of a 5% sodium fluoride varnish every 6 months

干预措施: fluoride varnish (Other)

control

Placebo Comparator

application of water onto tooth surface every year

干预措施: placebo control (Other)

SDF solution

Experimental

application of a 38% silver diamine fluoride solution onto tooth surface every year

干预措施: silver fluoride (Other)

结局指标

主要结局

dental caries

时间窗: 3 years

tooth decay appearing as a cavity on tooth surface

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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