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临床试验/NCT03851289
NCT03851289已完成不适用

Combination of Platelet-Rich Fibrin and Calcium Sulfate in Socket Augmentation

University of Malaya0 个研究点目标入组 10 人开始时间: 2016年4月22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
入组人数
10
主要终点
vertical dimension at baseline

研究概览

简要总结

This study evaluated the effectiveness of socket grafting material, combination of plate-rich fibrin and calcium sulfate. 5 subjects were grafted with this material, 5 subjects were grafted with combination of plate-rich fibrin and xenograft.

详细描述

Calcium sulfate (CS), an alloplastic material, is widely accepted as a socket grafting material and undergoes rapid and complete resorption. Studies have shown that CS creates an osteoconductive lattice that stimulates bone ingrowth into a defect. PRF poses multiple growth factors, anti-inflammatory cytokines and adhesion molecules. It is biologically active up to one week. The combination of these 2 materials will serve as good grafting material for tooth socket, in order to preserve vertical and horizontal dimensions.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •maxillary premolar teeth requiring extraction
  • •neighboring mesial and distal sound/restored teeth present
  • •alveolar bone level (measured from periapical radiographs) more than 50% of the root length
  • •age ranges from 25-55 years

排除标准

  • •bony fenestration of the socket wall confirmed from CBCT scan
  • •acute signs of infection
  • •periodontally compromised teeth
  • •absence of buccal plates
  • •any systemic disease which may hinder the healing process

研究组 & 干预措施

test (PRF-CS)

Experimental

After atraumatic tooth extraction, the socket was gently curettage and irrigated with saline. Combination of platelet-rich fibrin and calcium sulfate was placed into the socket followed by a PRF plug . Black silk suture (3-0) was placed on mesial, mid and distal using simple interrupted technique.

干预措施: platelet-rich fibrin and calcium sulfate (Combination Product)

control (PRF-X)

Active Comparator

After atraumatic tooth extraction, the socket was gently curettage and irrigated with saline. Combination of platelet-rich fibrin and xenograft (MinerOss® X) was placed into the socket followed by a PRF plug . Black silk suture (3-0) was placed on mesial, mid and distal using simple interrupted technique.

干预措施: platelet-rich fibrin and xenograft (Combination Product)

结局指标

主要结局

vertical dimension at baseline

时间窗: before extraction

measurements were done on radiograph (CBCT) images

horizontal dimension at baseline

时间窗: before extraction

measurements were done on radiograph (CBCT) images

soft tissue level at baseline

时间窗: before extraction

measurements were done on stone models

volume at baseline

时间窗: before extraction

measurements were done on radiograph (CBCT) images

次要结局

  • horizontal dimension after extraction(five months after extraction)
  • vertical dimension after extraction(five months after extraction)
  • soft tissue level after extraction(five months after extraction)
  • volume after extraction(five months after extraction)

研究者

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

Dr CHEAH CHIA WEI

Principal Investigator

University of Malaya

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