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临床试验/NCT05337449
NCT05337449Unknown不适用

Evaluation Of Changes in Children's Oral Health-Related Quality of Life Following Treatment of Early Childhood Caries With Caries Arrest Technique Using Silver Diamine Fluoride Versus Conventional Drill and Fill Technique A Randomized Clinical Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Oral Health to Quality of Life

研究概览

简要总结

The clinical trial aims to compare children's oral health-related quality of life (OHrQL) following caries arrest technique using SDF versus conventional drill and fill in the children with ECC

详细描述

Early childhood caries (ECC) has been an increasing issue in many countries and has become a significant health problem, especially in socially disadvantaged populations. ECC is a specific form of caries that occurs in children with primary teeth. ECC is characterized as "the early onset of caries in young children with often fast progression which can finally result in complete destruction of the primary dentition".

Management of cavitated carious lesions in primary teeth in very young children is time-consuming due to their lack of cooperation, so one of the alternative procedures could be performed with silver diamine fluoride (SDF), to its effectiveness in arresting the activity of carious lesions (cavitated and non-cavitated). It is easy to apply even outside dental offices, and relatively inexpensive solutions can be used particularly when compared to restorative intervention.

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
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • Children Aged 3 to 5 years, in good general health and medically within normal.
  • The parents provided written informed consent.
  • Carious vital primary molars with reversible pulpitis.
  • Restorable teeth.
  • Normal Radiographic findings.

排除标准

  • Unable to attend follow-up visits.
  • Refusal of participation.
  • Previously accessed teeth.

结局指标

主要结局

Oral Health to Quality of Life

时间窗: 6 month intervene

will be evaluated by a questioner answered by the parents

次要结局

  • Side effects(6 month intervene)
  • Parental satisfaction(6 month intervene)
  • Time of the procedure(6 month intervene)
  • Postoperative pain and sensitivity(6 month intervene)
  • The cost effectiveness(6 month intervene)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gala Sharif Osman

principal investigator

Cairo University

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