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临床试验/NCT03003013
NCT03003013Unknown4 期

Effect of Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) on Bone Regeneration in an Odontogenic Maxillary Cyst: a Randomized Clinical Trial

Cairo University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2016年11月最近更新:
适应症
干预措施

试验速览

阶段
4 期
入组人数
28
试验地点
1
主要终点
Swelling

研究概览

简要总结

Effect of Biphasic Bone Graft Material (BGM) in combination with autologous platelet-rich fibrin (PRF) on bone regeneration in an odontogenic maxillary cyst: a randomized clinical trial

详细描述

Odontogenic cysts are the most common form of cystic lesions that affect the oral and maxillofacial region. Their origin, mechanism of growth, as well as treatment problems have been often discussed.

Platelet rich fibrin (PRF) is a second generation platelet concentrate first developed in France by Choukron et al in 2001, prepared from centrifuged autologous blood. It is a fibrin clot rich in platelets without addition of bovine thrombin, calcium chloride or anticoagulant during preparation thus eliminating the risks associated with the use of thrombin. Platelet rich fibrin is derived from a natural and progressive polymerization occurring centrifugation. A progressive or relatively slow polymerization mode may increase incorporation of the circulating cytokines in the fibrin meshes which are then released in a relatively long-term and controllable way which in turn will help in soft tissue healing and accelerated bone regeneration.

Blood Derivatives Enhancing Bone Regeneration:

1-Fibrin glue: It is classically described as a two component mixture in which concentrated fibrinogen factor XIII and fibronectin are added to thrombin ,calcium choloride and an inhibitor of fibrinolysis to form a fibrin clot .

Shortcomings:

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

入选标准

  • Inclusion criteria
  • Age range is 15: 60 years old.
  • A maxillary odontogenic cysts larger than 3 cm in size.
  • Exclusion criteria
  • A maxillary odontogenic cysts smaller than 3 cm in size.
  • A mandibular odontogenic cysts.
  • Non odontogenic cysts.
  • Patients with thrombotic risk factors or taking anti-platelets drugs.
  • Patients with systemic diseases

排除标准

  • 未提供

研究组 & 干预措施

Biphasic Bone Graft With Autologous Platelet-rich Fibrin

Active Comparator

Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material in combination with PRF in the cystic cavity

干预措施: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) (Procedure)

Biphasic Bone Graft Material only

Active Comparator

Patients will undergo complete removal of the cystic cavity with the application of SYMBIOS biphasic bone graft material without PRF in the cystic cavity

干预措施: Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF) (Procedure)

结局指标

主要结局

Swelling

时间窗: six weeks

Visual analogue scale

次要结局

  • bone regeneration(from six to nine months)

研究者

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

Sherif Abdel Monem Abdel Aziz

Master student

Cairo University

研究点 (1)

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