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临床试验/NCT03698188
NCT03698188Unknown不适用

Evaluation of the Efficacy of Injectable Platelet-Rich Fibrin Versus Platelet-Rich Plasma in the Regeneration of Necrotic Immature Maxillary Anterior Teeth. (A Randomized Clinical Trial)

Cairo University0 个研究点目标入组 24 人开始时间: 2018年11月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
24
主要终点
Increase in root length

研究概览

简要总结

Injectable platelet-rich fibrin (I-PRF) is a flowable blood concentrate that is entirely natural and allows ease of access and flow within the root canal. It was first developed in 2014 by modifying the centrifugation parameters. I-PRF has great potential in the field of endodontics. At present, it is still in its infancy and needs to be explored with regard to its regenerative efficacy.

To the best of our knowledge, this study is the first to clinically and comparatively investigate Platelet-rich plasma (PRP) and I-PRF.

详细描述

An ideal treatment option for an immature necrotic tooth is the regeneration of pulp-like tissue that is capable of boosting the continuation of normal root development. The use of platelet concentrates for that purpose is a clinically relevant, minimally invasive approach which has a promising potential of reducing the healing period. Among which, the most commonly employed is the Platelet-Rich Plasma that is not entirely natural. It involves the use of non-autologous anticoagulants such as bovine thrombin to maintain the fluid consistency which prevents clot formation and thus impairs wound healing, affects the coagulation process and can also trigger an immune reaction, thereby, suppressing regeneration.

PRP offers a short-term release of most of the growth factors unlike the Platelet-Rich Fibrin which allows for a more sustained release. PRF does not require any biochemical handling of blood and is easy to procure but due to the gel-like consistency, its adaptability within the root canal requires excessive removal of root dentin.

In addition, the application of recombinant growth factors within the root canal is associated with high cost which hinders its applicability in the common clinical practice.

Therefore, a new regenerative technique is required that combines the advantages of both PRP and PRF while overcoming their drawbacks.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
10 Years 至 25 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients having necrotic maxillary anterior tooth/teeth due to caries or trauma
  • Radiographic criteria: preoperative radiograph showing incomplete root formation with a wide apical foramen.
  • Positive patient/guardian compliance for participation in the study.

排除标准

  • Uncooperative patient
  • Lack of patient commitment to the treatment plan and the follow-up period
  • Mature necrotic anterior teeth due to caries or trauma
  • Vital maxillary anterior teeth with open apices
  • Non-restorable teeth
  • Grossly decayed or fractured teeth that require post and core as final restorations
  • Presence of periodontal pockets
  • Radiographically: presence of external or internal root resorption, fracture lines or cracks

研究组 & 干预措施

Injectable platelet-rich fibrin

Experimental

A platelet concentrate will be prepared from the patient's own blood in plain plastic tubes, without the use of anticoagulants, and applied immediately within the root canal before coagulation.

干预措施: Injectable platelet-rich fibrin (Procedure)

Platelet-rich plasma

Active Comparator

A platelet concentrate will be prepared from the patient's own blood in tubes containing anticoagulants to maintain the fluid consistency and applied within the root canal.

干预措施: Platelet-rich plasma (Procedure)

结局指标

主要结局

Increase in root length

时间窗: one year follow-up

root length will be measured on the preoperative and postoperative radiographs and the percentage increase in length will be calculated

次要结局

  • Restoration of tooth sensitivity(one year)

研究者

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

Maha Mohamed Abou-Heikal

assistant lecturer

Cairo University

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