Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

赞助:

合作者:

信息的提供 (责任方):

Maha Mohamed Abou-Heikal，Cairo University

追踪信息

首次提交日期 ^ICMJE

October 3, 2018

首次发布日期e ^ICMJE

October 5, 2018

最后更新发布日期

October 5, 2018

预计研究开始日期 ^ICMJE

November 2018

预计主要完成日期

May 2019 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Increase in root length[ Time Frame: one year follow-up ]

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

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Restoration of tooth sensitivity[ Time Frame: one year ]
sensitivity will be measured by an electric pulp tester

描述性信息

简略标题 ^ICMJE

Comparative Evaluation of the Regenerative Capacity of Two Platelet Concentrates

正式标题 ^ICMJE

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

简要概况

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.

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Parallel Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: Injectable platelet-rich fibrin
A blood sample will be drawn from the patient, centrifuged at 700 rpm for 3 minutes and the upper yellow fluid will be collected by a plastic syringe, avoiding the inclusion of the red blood cells underneath, and will be introduced within the root canal.
Procedure: Platelet-rich plasma
A blood sample will be drawn from the patient, centrifuged at 3000 rpm for 10 minutes and the upper yellow fluid will be collected by a plastic syringe, avoiding the inclusion of the red blood cells underneath, and will be introduced within the root canal.

研究工具

Experimental: Injectable platelet-rich fibrin
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.
Active Comparator: Platelet-rich plasma
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.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

May 2020

预计主要完成日期

May 2019 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - 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. Exclusion Criteria: - 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

性别

参与研究的性别:

All

年龄

最小年龄：7 Years ，最大年龄：25 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Maha Mohamed Abou-Heikal，Cairo University

研究赞助商 ^ICMJE

Cairo University

合作者 ^ICMJE

研究员 ^ICMJE

Study Director: Jealane El-Shafei, PhD Professor Doctor of Endodontics, Faculty of Oral and Dental medicine, Cairo University.
Study Director: Nihal Nabil, PhD Lecturer of Endodontics, Faculty of Oral and Dental medicine, Cairo University.

PRS 账户

Cairo University

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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