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临床试验/NCT03930927
NCT03930927Unknown早期 1 期

Evaluation of the Re-mineralizing Effect of Biomimetic Self-Assembling Peptides in Post Orthodontic White Spot Lesions Compared to Fluoride-Based Delivery Systems

Raneen Ahmed0 个研究点目标入组 32 人开始时间: 2019年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
发起方
入组人数
32
主要终点
Remineralizing process

研究概览

简要总结

During re-mineralization of white spot lesion, Will biomimetic self-assembling peptides improve the re-mineralizating effect of the post orthodontic white spot lesion compared to fluoride-based delivery systems?

详细描述

Conservative dentistry no longer prefers the "drill and fill" concept and advocates reversal of lesions via remineralization. . Remineralization is the process of restoring minerals - again, in the form of mineral ions - to the hydroxyapatite latticework structure. It is three-dimensional, and the lost ions must be replaced with ions having the exact same shape, size and the same electrical charge as those lost from the lattice.

Fluoride and self-assembling peptides have been used as adjuncts to enhance remineralization.

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 (Participant)

入排标准

年龄范围
12 Years 至 22 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with post orthodontic white spot lesion.
  • Patients with good oral hygiene.
  • Patients with good general health.
  • Cooperative patients.
  • Subjects who signed the informed consent.

排除标准

  • Patients with tetracycline pigmentation and dental fluorosis.
  • Enamel cavitation.
  • Disable patient.
  • patient with any systemic disease or severe medical complications.

研究组 & 干预措施

Self Assembling peptide

Experimental

intervention

干预措施: Self Assembling peptide (Drug)

Self Assembling peptide

Experimental

intervention

干预措施: remineralizing agent (Drug)

Fluoride

Experimental

Comparator

干预措施: Self Assembling peptide (Drug)

Fluoride

Experimental

Comparator

干预措施: remineralizing agent (Drug)

结局指标

主要结局

Remineralizing process

时间窗: 6 months

using DIAGNOpen.

次要结局

  • Visual assessment(6 months)

研究者

发起方
Raneen Ahmed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Raneen Ahmed

assistant lecturer

Cairo University

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