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临床试验/NCT05249231
NCT05249231Unknown不适用

Parental Satisfaction of Hall Technique Versus Silver Diamine Fluoride (SDF) in the Management of Carious Primary Molars Randomized Clinical Trial

Cairo University0 个研究点目标入组 22 人开始时间: 2022年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
22
主要终点
parental satisfaction of Hall technique versus silver diamine fluoride

研究概览

简要总结

  • The aim of this study is to assess parental satisfaction and duration of the procedure of Hall and silver diamine fluoride techniques in the treatment of carious primary molars with healthy pulp.
  • primary ourcome: parental satisfaction measurement device: four point likert scale measurement unit: 1-2-3-4
  • secondary outcome: duration of the procedure measurement device: Digital chronometer measurement unit: minutes

详细描述

dental caries is a critical disease that affects primary teeth in early childhood. It occurs through interaction between acid-producing bacteria and carbohydrates on tooth surface. progression of caries depends on several factors such as type of diet, oral hygiene, cariogenic bacterial load and salivary flow. to control caries, the life style of a child should be improved by having healthy non-cariogenic diet and proper oral hygiene.

caries can be treated by advanced non-invasive methods such as: Hall technique and Silver diamine fluoride which are based on controlling the acidic medium of a cariogenic biofilm without removal of caries thus, arresting the progression of demineralization and restoring the function of diseased molars.

The first report on Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique through a more simplified method.

Previous studies have recommended silver diamine fluoride (SDF) to arrest early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention.

The trial is seeking the measurement of effectiveness of two modalities (Hall & SDF techniques) to achieve best acceptable treatment for caries in developing countries which have high caries index.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • 1 age: from 4 to 6 years old
  • 2 primary molars with enamel/dentin caries without pulp exposure

排除标准

  • 1 signs and symptoms of necrosis
  • 2 root caries
  • 3 spontaneous pain

研究组 & 干预措施

Hall technique

Active Comparator

group of carious primary molars to be treated by hall technique

干预措施: Hall technique (Device)

silver diamine fluoride

Experimental

group of carious primary molars to be treated by silver diamine fluoride

干预措施: Silver diamine fluoride (Drug)

结局指标

主要结局

parental satisfaction of Hall technique versus silver diamine fluoride

时间窗: during procedure

To estimate parental satisfaction with treatment, parents are going to be asked, "What's the level of your satisfaction with the treatment your child received? "Using a 4 point likert scale (very low equals 1, low equals 2, medium equals 3 and high equals 4)

次要结局

  • treatment time(during procedure)

研究者

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

Hadir Emad

Principal Investigator

Cairo University

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