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临床试验/NCT02801552
NCT02801552已完成不适用

Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using Platelet-rich Fibrin : A Pilot Randomized Controlled Trial

Fujian Medical University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Evidence of periapical healing

研究概览

简要总结

This study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative endodontic procedure.

详细描述

The conventional method of regenerative endodontic procedure using a blood clot as scaffold materials has shown successful results. However, it is very difficult to induce bleeding and place mineral trioxide aggregate over a blood clot. Platelet-rich fibrin (PRF), a second-generation platelet concentrate. PRF is a matrix of autologous fibrin containing a large quantity of platelets, growth factors and leukocytes. PRF preparation technique is very simple, inexpensive and doesn't require any chemical agents. The purpose of this study is to test the hypothesis that the use of PRF in regenerative endodontic procedure of immature permanent teeth with apical periodontitis will accelerate periapical bone healing and stimulate the root maturation.

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
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between 6 and 18 years of age
  • Provision of Informed Consent
  • Cooperative in the dental chair
  • Permanent immature teeth with apical periodontitis and incomplete root development

排除标准

  • Have a medical history that may complicate treatment
  • Unlikely to be able to comply with the study procedures

结局指标

主要结局

Evidence of periapical healing

时间窗: 12 months

次要结局

  • Evidence of root development(24 months)
  • Evidence of pulp sensibility(24 months)

研究者

发起方
Fujian Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaojing Huang

DDS, PhD, Professor

Fujian Medical University

研究点 (1)

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