跳至主要内容
临床试验/NCT04321109
NCT04321109已完成不适用

Alveolar Ridge Preservation Using Collagen Material and Allograft: A Randomized Controlled Trial

Yasmine Fouad0 个研究点目标入组 14 人开始时间: 2016年6月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
14
主要终点
clinical score

研究概览

简要总结

Seven Patients who need implants to replace non-restorable teeth in the esthetic zone.

Intervention Group (1): Seven extraction sockets that received the collagen matrix (Collagen cone) for alveolar ridge preservation.

Comparison Group (2): Seven extraction sockets that were treated with mineralized cortico-cancellous bone allograft for alveolar ridge preservation.

Outcome

  1. Alveolar ridge preservation both in height and in width to improve implant success rate
  • The height of alveolar ridge was assessed clinically using a periodontal probe.
  • The width of the alveolar ridge was measured after three months after extraction using a caliper clamp.
  • Changes in the width and height of alveolar bone were evaluated in merged axial and sagittal views using the I-CAT superimposition system (CBCT).

2- Evaluation of newly formed bone quality was performed by histological examination and histomorphometric analysis.

3- Immuno-histochemical staining was done using polyclonal antibody to detect (BMP-2) marker of bone formation

详细描述

The aim of the present study was to compare three months post-extraction augmented ridge using collagen matrix versus mineralized cortico-cancellous bone allograft. This comparison was done clinically, histologically, immunohisto-chemically and radiologically.

• Clinical parameters included; vertical bone height and bone width that were recorded at baseline and at three months after extraction. Moreover, histomorphometric parameters included; area fraction of osteoid and mature bone three months after extraction by histomorphometric analysis. Immunohistochemical analysis using polyclonal antibody to detect BMP-2 marker of bone formation. Radiographic parameters included superimposition of baseline CBCT, three months after extraction and another one six months after loading with subsequent measurement of bone height, bone width and bone density.

A core biopsy was taken three months after tooth extraction which has undergone histomorphometric and immunohistochemical analysis; implant placement was also done at the same time.

In the present study, it was found that the mean bone height decreased with a higher percent in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between both groups.

In addition, this study showed that the mean bone width decreased more in collagen matrix group than mineralized cortico-cancellous bone allograft group with a non significant difference between them.

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 (Outcomes Assessor)

盲法说明

Results were sent to Outcome Assessor masked , so he was not able to know results belong to which group

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients were medically free .
  • Two teeth indicated for extraction due to either severe decay, tooth fracture or failed endodontic treatment.

排除标准

  • Patients with poor oral hygiene or not willing to perform oral hygiene measures.
  • Pregnant and breast-feeding females.
  • Smokers , Teeth with periodontal or periapical infections.
  • Patients with malocclusion.
  • All patients who had known contraindication to dental implant surgery (e.g: bleeding tendency, radiotherapy, taking bisphosphonate)

结局指标

主要结局

clinical score

时间窗: change from baseline at 12 weeks

Dimensional changes in alveolar ridge after alveolar ridge preservation both clinically and radiographically

次要结局

  • BMP-2(detected at 12 weeks)

研究者

发起方
Yasmine Fouad
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasmine Fouad

lecturer of oral medicine and periodontology

Ain Shams University

相似试验