跳至主要内容
临床试验/CTRI/2019/06/019831
CTRI/2019/06/019831尚未招募不适用

Effectiveness of a simplified method (Hall’s Technique) of managing caries primary molar teeth in young children using preformed metal crowns.

Three M1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2019年6月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
220
试验地点
1
主要终点
Clincial effectiveness and acceptability of the Hall Technique in young children between 3 to 8 years

研究概览

简要总结

Stainless steel crowns have beenrecommended in the literature as restorative material of choice in primarymolars with multi surface caries involvement, following pulp therapy and inchildren at high risk of dental caries. It has been considered most costeffective since they don’t require frequent replacement. Generally stainlesssteel crowns are considered in the following situation: high risk patients withsingle surface/ multi surface caries/ demineralization under eight years ofage; after pulp therapy; teeth with extreme wear facets and more than two yearsbefore exfoliation. Despite SSC being recommended as the ideal restoration formanaging primary molar where caries involves two or more surfaces and evidenceof their effectiveness, SSC are not widely used. The standard techniques involvestooth preparation under local anesthesia which was not widely accepted by thepreschool children. This lead to a novel simplified method of using SSC, theHall Technique being investigated. This method uses SSC which are filled withAntidecay cement (GIC) and simply pushed onto the tooth with no caries removalor tooth preparation. Efficient sealing / cementing enhances the success ofrestoration by preventing bacterial ingress and further progress of the lesion.With the Hall Technique, the process of fitting the crown is quick andnon-invasive. The crown is seated over the tooth with no caries removal ortooth preparation of any kind, and local anesthesia is not required. By doing this technique there willbe no impact to developing tooth, if any caries left untreated which will haveimpact over the developing permanent tooth, so based on the extend of thecaries they need to be treated either as restoration or with SSC. There is norisk for doing this procedure in children, this makes the child morecomfortable for the procedure.

研究设计

研究类型
Observational

入排标准

年龄范围
3.00 Year(s) 至 8.00 Year(s)(—)
性别
All

入选标准

  • 1.Participants aged 3 to 8 years of age
  • No relevant medical history
  • No symptoms of reversible pulpitis (Pain on eating)
  • OPG or Bitewings, IOPA radiographs available
  • No inter-radicular radiolucency on the selected primary molar tooth.

排除标准

  • Participants with special healthcare needs and developmental anomalies.
  • Caries involving pulp.
  • Radiographically radiolucency extending beyond a middle third of dentine.
  • Previous symptoms of nocturnal pain, inter-radicular radiolucency.
  • Clinical signs or symptoms of irreversible pulpitis, dental abscess or mobility.

结局指标

主要结局

Clincial effectiveness and acceptability of the Hall Technique in young children between 3 to 8 years

时间窗: Thirty Six months

次要结局

  • Lifespan of Stainless Steel crown with Halls Technique(Thirty Six months)

研究者

发起方
Three M
申办方类型
Other [Dental Material company]

研究点 (1)

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