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临床试验/NCT02443896
NCT02443896已完成不适用

A Pilot Study to Investigate the Use of Pit and Fissure Sealants in Children Requiring Caries Related Dental Extractions Under a Chair General Anaesthetic

University of Birmingham1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Caries incidence

研究概览

简要总结

The purpose of thus study is to assess the feasibility and inform the planning of a proposed definitive randomised controlled clinical trial to investigate the efficacy of sealing permanent molars in children requiring caries related extractions under a chair General Anaesthetic.

详细描述

Objective:

To evaluate,

  1. The ability to recruit based on failure to meet exclusion criteria, declining to participate or other reasons and retention rates based on subsequent withdrawals.

  2. Feasibility and acceptability of placing sealants in this setting, based on compliance with the intervention.

  3. Sealant retention rates based on the proportion of sealants that were fully intact, partially intact or lost after 24 months.

  4. Two-year incidence of caries in permanent molars that were sound and suitable for sealants at the time of the pre-GA assessment, based on the proportion of children with:

  5. Experience of caries into dentine in at least one permanent molar

  6. Untreated caries into dentine in at least one permanent molar

  7. Oral health related Quality of Life (OHRQoL) two years following caries related extractions under GA, based on the Child-Oral Impacts on Daily Performances (Child-OIDP) scale and separate questions relating to specified oral symptoms.

  8. Oral health support provided by referring practitioners, within the 2 years following the dental GA, based on,

  9. Structured interview questionnaire to record parents' experience of preventive advice and treatment received, following the GA extractions

  10. Sealants identified at follow up that were not present at baseline or provided as part of the study

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
5 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Caries incidence

时间窗: 12 months

The incidence of dental caries in permanent molars will be recorded.

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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