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临床试验/NCT04422860
NCT04422860Unknown2 期

Remineralization Efficacy of Gum Arabic Varnish Versus Fluoride Varnish and CPP-ACP With Fluoride Based Varnish on Initial Carious Lesions. a Randomized Controlled Clinical Trial.

Cairo University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2020年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
90
试验地点
1
主要终点
Remineralization through determination of lesion progression or regression

研究概览

简要总结

The aim of this study is to evaluate the remineralizing capacity of Gum Arabic varnish and its implementation into clinical practice.

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
17 Years 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with initial carious lesions.
  • Proper Oral hygiene.

排除标准

  • Patients with a compromised medical history.
  • Patients with active severe periodontal disease.
  • Patients with hypoplastic or hypomineralized teeth.

研究组 & 干预措施

Gum Arabic varnish

Experimental

Gum arabic (Acacia senegal) is an exudate obtained from Acacia senegal stems and roots, and other similar African Acacia species. It consists mainly of high molecular weight polysaccharides high concentrations of calcium, magnesium, and potassium salts which can potentially increase tooth remineralization.

干预措施: Gum Arabic varnish (Drug)

Sodium Fluoride varnish

Active Comparator

The gold standard remineralizing agent recommended by the guidelines.

干预措施: Proflourid Varnish,VOCO (Drug)

10% w/v CPP-ACP, 5% sodium fluoride varnish

Active Comparator

CPP-ACP is the most studied non fluoride remineralizing agent.

干预措施: MI Varnish,GC Japan Inc. (Drug)

结局指标

主要结局

Remineralization through determination of lesion progression or regression

时间窗: Change from baseline at 3,6, 9 months

Determination of lesion level by DIAGNOdent which provides a laser fluorescence feedback to give a numerical readout reflects the amount of demineraliztion.

次要结局

  • Caries lesion activity assessment(Change from baseline at 3,6, 9 months)

研究者

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

Ahmed Hesham samaha

Master's Degree Student- Faculty of Dentistry

Cairo University

研究点 (1)

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