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临床试验/NCT02915419
NCT02915419Unknown不适用

Evaluation of Survival of Mature Second Premolar With Periapical Lesion Following Different Regenerative Treatment Protocols

Cairo University0 个研究点目标入组 30 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
Survival

研究概览

简要总结

This study aims to compare the ability of different regenerative protocols in the treatment of mature necrotic

详细描述

American Dental Association adopted the tissue engineering concept and pulp regeneration in 2009. Regeneration was focused on the treatment of immature necrotic teeth so as to allow root completion, improving both the functionality and durability of the affected tooth. Utilizing a blood clot in the affected tooth with immature roots was very beneficial, as it acts as a scaffold for the migration of stem cells and morphogens to allow regeneration .

Based on the success of pulp regeneration in treating immature teeth, ambitious dentists started to look forward on regenerating the pulp of mature teeth as a substitution to the conventional root canal treatment. On the other hand, lots of clinicians were very doubtful about treating mature teeth with the same protocol, as the small apical foramen might not provide a good portal for the entry of stem cells and growth factors, which in turn is very important for the success of pulp regeneration.Doubts in treating mature apex encouraged researchers to look for an alternative to the stem cells other than the apical papilla, from this concept the idea for using an alternative source of stem cells and growth factors as platelet rich plasma (PRP) emerged. The use of platelet rich plasma (PRP) as a potentially ideal scaffold for regenerative endodontic therapy has been reported in the treatment of immature teeth. However, the use of bovine thrombin for the activation of PRP has been an issue of controversy, as it requires non autologous anticoagulant known to hinder the process of pulp regeneration.

This led to the development of the second generation, platelet concentrate known as Choukroun's platelet rich fibrin (PRF) which is totally autologous in nature. Platelet rich fibrin (PRF) was very promising, but it is debatable whether to use PRP or PRF.The objective of this study is to evaluate novel regenerative techniques, utilizing platelet rich plasma and platelet rich fibrin in treatment of second premolar teeth with necrotic pulp, mature apex, and periapical lesion. This is a trial to prolong the survival of the affected tooth, and to aid in complete healing of periapical lesion, and to regain pulp vitality and sensitivity.

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
None

入排标准

年龄范围
15 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.
  • Non-pregnant females Single canalled second premolar
  • Patients having non-vital, mature, second premolar teeth, radiographic evidence of periapical lesion.
  • Positive patient/Guardian compliance for participation in the study.

排除标准

  • Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.
  • Non-restorable coronal portion of teeth involved in the trial. Vital teeth Immature teeth Traumatized teeth Radiographic evidence of external or internal root resorption. Any criterion, not mentioned in the inclusion criteria

结局指标

主要结局

Survival

时间窗: 1 year

how long will the tooth survive after treatment, testing the durability of tooth

次要结局

  • healing(1 year)
  • vitality(1 year)

研究者

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

Wagih Tarek Ali

assistant lecturer

Cairo University

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