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临床试验/NCT05889377
NCT05889377已完成不适用

Socket Preservation Technique Using Bovine Bone, Platelet Rich Fibrin Or A Combination Of Both: A Clinical, Radiographic And Histological Assesment At 4 Months

Saint-Joseph University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2021年11月3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
80
试验地点
1
主要终点
Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software

研究概览

简要总结

Post extraction alveolar bone resorption is one of the main challenges that face oral implantologists in their daily surgical practice (1). To palliate to post-extraction resorption, advanced bone grafting and regeneration techniques have been described (2). However, these procedures, although well documented and validated, still have relatively high complication rates and patient morbidity, in addition to the elevated cost and duration of treatment (3). Socket preservation is a very useful technique in order to counter post extraction resorption issues, therefore eliminating the need for future complicated and delicate regeneration procedures (4). Many biomaterials were proposed for socket preservation such as allografts and bovine hydroxyapatite (5). Recently autologous platelet concentrates such as Platelet Rich Fibrin PRF were described as a potential socket filler material (6).

In the proposed protocol, fresh extraction sockets will be either grafted by a bovine bone substitute, a PRF plug or a mixture of both. Sockets will then be clinically and radiographically monitored over time to assess three-dimensional soft and hard tissue stability. Bone quality will be histologically examined at 6 months implant placement. A no graft group will serve as control.

The results of this study may be of major importance since they could give an objective idea of the most efficient socket preservation technique, thus offering simple and secure oral rehabilitation solutions for both patient and practitioner.

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
18 Years 至 62 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients will require single tooth extraction and subsequent implant rehabilitation.
  • Patients over 18 years of age.
  • Patients willing to comply with the study requirements (signed consent form)
  • Good oral hygiene and no signs of active periodontal infection
  • No compromising medical status
  • < 10 cigarettes smoking per day

排除标准

  • acute myocardial infarction within the last two months;
  • Uncontrolled coagulation disorders;
  • uncontrolled diabetes (HBA1c> 7.5);
  • radiation therapy to the head \ neck region in the last 24 months;
  • immunocompromised patients, HIV positive or receiving chemotherapy in the last five years;
  • past or present treatment with intravenous bisphosphonates;
  • psychological or psychiatric problems;
  • abuse of alcohol or drugs;

结局指标

主要结局

Hard tissue change by measuring bone profil retraction between 0,4 and 12 months using 3D slicer software

时间窗: 4 and 12 months

Comparison of the bone profile change by CBCT dicom files superimposition at different time frame

Soft tissue change by measuring gingival retraction between 0,4 and 12 months using 3D slicer sftware

时间窗: 4 and 12 months

Comparison of the soft tissue profile change by STL files superimposition at different time frame

次要结局

未报告次要终点

研究者

发起方
Saint-Joseph University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Christian Makary

Professor

Saint-Joseph University

研究点 (1)

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