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临床试验/NCT04765904
NCT04765904Unknown不适用

Clinical Efficiency and Treatment Failure of Hall Versus SDF Techniques in the Management of Carious Primary Molar: Randomized Clinical Trial.

Cairo University0 个研究点目标入组 120 人开始时间: 2021年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
120
主要终点
percentage of Treatment failure:

研究概览

简要总结

This study will compare two non- invasive treatment options: Hall technique and 38% Silver diamine fluoride. Both are methods used to create a more favorable environment without removal of caries leading to the arrest of the progression of demineralization process and restoring the function of the diseased molars.

详细描述

Detailed Description:

Dental caries, also known as tooth decay, it can occur in primary teeth in early childhood, is formed through interaction between acid-producing bacteria and carbohydrate. The caries develops in both the crowns and roots of teeth. Progress of caries depended on the lifestyle of the child (as high numbers of cariogenic bacteria, inadequate salivary flow, insufficient fluoride exposure and poor oral hygiene). To avoid this disease should follow the proper oral hygiene and improve lifestyle . A lot of methods found to treatment the decayed tooth - like; Hall technique and Silver diamine fluoride The first report on the 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, placed them using a simplified method2

Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)

研究设计

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

盲法说明

not possible, since interventions are different

入排标准

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

入选标准

  • •Age: From 4 to 6 years
  • •Caries in primary molars within enamel/dentin without pulp disease

排除标准

  • •Presence of signs and symptoms of necrosis
  • •Root caries
  • •Spontaneous pain

研究组 & 干预措施

Hall Technique

Active Comparator

The Hall Technique is a non-invasive treatment for decayed molar teeth. Decay is sealed under preformed (stainless steel) crowns, avoiding drilling

干预措施: Hall technique (Procedure)

SDF

Experimental

a clear liquid that combines the antibacterial effects of silver and the remineralizing effects of fluoride, is a topical therapeutic agent for managing caries lesions in young children

干预措施: SDF (Procedure)

结局指标

主要结局

percentage of Treatment failure:

时间窗: one year

1. Obvious furcation or periapical radiolucency by radiographic examination. 2. (Internal and external) resorption by radiographic examination. 3. Sensitivity to percussion by clinical examination ( dental mirror ). 4. Loss of SSC crown by clinical examination ( visual examination ).

次要结局

  • Canine overbite(one year)
  • Arresting caries in SDF(one year)

研究者

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

Mostafa Amin Mahmoud El.byoumi

principle investigator

Cairo University

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