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临床试验/NCT03408418
NCT03408418已完成不适用

Tomographic and Histological Evaluation of Postextraction Sockets Treated With Leucocyte- and Platelet-rich Fibrin: a Randomized Clinical Trial

Rio de Janeiro State University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2018年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
48
试验地点
2
主要终点
Width resorption 1mm

研究概览

简要总结

The effect of leucocyte- and platelet-rich fibrin (L-PRF) for enhancing the healing after dental extractions is still a matter of debate. The available literature suggests that L-PRF performs positive effect to improve alveolar preservation resulting in less bone resorption on extraction sockets. L-PRF is a second generation of platelet concentrate produced without biochemical blood manipulation. L-PRF is composed by three key parameters: first, the presence of platelets; second, the presence of leucocytes; third, the density and complex organization of the fibrin matrix architecture produced by a natural polymerization process. The theory is that this key parameters acts to produce a faster bone healing.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
17 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Health patients, American Society of Anesthesiologists (ASA) I or II
  • (2) Patients who need to submit tooth extraction (pre-molar, canine and incisor teeth - uniradicular teeth or teeth with fused roots) which present ideal conditions to receive dental implants after 3 months.

排除标准

  • Systemic diseases related with healing disorders
  • Poor oral hygiene
  • Pregnant or lactating patient
  • Use of flap elevation for dental extraction

研究组 & 干预措施

L-PRF group

Experimental

The use of autologous leucocyte- and platelet-rich fibrin in alveolar sockets after dental extraction.

干预措施: Platelet-rich fibrin (Procedure)

Control

No Intervention

Conventional tooth extraction without any bone substitute.

结局指标

主要结局

Width resorption 1mm

时间窗: After 3 months

The ridge width differences between baseline and after three months of healing 1 mm below the crest.

次要结局

  • Histological Analysis - fibrous tissue(After 3 months)
  • Histological Analysis - bone cells(After 3 months)
  • Histological Analysis - capillary vessels(After 3 months)
  • Histological Analysis - new bone formation(After 3 months)
  • Width resorption 3mm(After 3 months)
  • Width resorption 5mm(After 3 months)

研究者

发起方
Rio de Janeiro State University
申办方类型
Other
责任方
Principal Investigator
主要研究者

João Vitor dos Santos Canellas, DDS MS

PhD Student

Rio de Janeiro State University

研究点 (2)

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L-PRF in Alveolar Ridge Preservation | 临床试验