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临床试验/NCT01829334
NCT01829334已完成2 期

A Comparative Study on the Cost-effectiveness of Four Methods in Preventing Fissure Caries in Permanent Teeth

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 329 人开始时间: 2006年6月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
329
试验地点
1
主要终点
dental caries

研究概览

简要总结

The aim of this proposed study is to investigate the cost-effectiveness of four methods in preventing fissure caries in permanent teeth, which is the most prevalent dental disease in primary school children in China.

The four caries prevention methods are: resin fissure sealant, atraumatic restorative treatment (ART) sealant, sodium fluoride varnish, and silver diamine fluoride (SDF) solution.

The specific study objectives are:

  1. to describe longitudinally the clinical outcomes of using the above four methods to prevent dental caries in the pits and fissures of permanent first molars in school children,
  2. to describe the cost of using the above four methods to prevent dental caries in an outreaching dental care programme in China, and
  3. to compare the cost-effectiveness of the above four caries prevention methods.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

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

排除标准

  • •children with major systemic disease or on long-term medication
  • •children not cooperative and refuse dental treatments

研究组 & 干预措施

Resin dental sealant

Active Comparator

Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement

干预措施: Resin dental sealant (Other)

ART dental sealant

Experimental

ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement

干预措施: ART dental sealant (Other)

Sodium fluoride varnish

Experimental

Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months

干预措施: Sodium fluoride varnish (Other)

Silver fluoride solution

Experimental

Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months

干预措施: Silver fluoride solution (Other)

结局指标

主要结局

dental caries

时间窗: 3 years

development of carious cavity after 3 years

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

LO, Edward Chin Man

Professor

The University of Hong Kong

研究点 (1)

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