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A 14 Weeks Longitudinal Study to Investigate the Effect of Leukocyte- Platelet Rich Fibrin Plug on the Quality of the Newly Formed Bone in Ridge Preservation Procedure Following a Tooth Extraction. It is a Clinical, Radiographic and Histomorphometric Study.

2021年5月20日 更新者:Firas Al Yafi

Ridge Preservation With Leukocyte Platelet Rich Fibrin: A Clinical, Radiographic, and Histomorphometric Study.

This 14 weeks longitudinal study will be conducted from March 2018 to June 2020, with a 40 participants. No subjects has received placebo medication at any point in the research procedures.

Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.

研究概览

详细说明

This 14 weeks longitudinal study was conducted from March 2018 to June 2020, with a 27 participants. No subjects has received placebo medication at any point in the research procedures.

The proposed sample population has been recruited from the patient population of the University of Kentucky College of Dentistry clinics and the patient must have had an unsalvageable tooth that was planned for extraction and delayed implant placement and was assigned into a control group and a test group by chance. Fifteen extraction socket sites of the test group were filled with autogenous L-PRF Plug (Intralock) and d-PTFE membrane (Cytoplast) was laid on the top to seal the extraction socket. In the control group, d-PTFE membrane (Cytoplast) was laid on the top of twelve extraction sockets to allow natural blood clot formation in the extraction socket.

The primary aim is to assess the quality of the newly formed bone at 14 weeks the time of implant placement by comparing the percentage of new vital bone in the histomorphometric analysis. The second aim was to assess the horizontal and vertical changes of the residual bony ridge using Cone Bean Computerized Tomography (CBCT) analysis at baseline immediately after tooth extraction at 12 weeks of healing.

Null hypothesis: The use of L-PRF plug, in combination with non-resorbable, open barrier membrane technique to fill the extraction sockets will have no effect on the quality of the newly formed bone nor on the dimensional changes of the ridge, compared to non-resorbable, open barrier membrane technique with natural blood clot.

研究类型

介入性

注册 (实际的)

27

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Kentucky
      • Lexington、Kentucky、美国、40536
        • Univerisity of Kentucky College of Dentistry

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  • The subject must have an unsalvageable tooth that is planned for extraction and delayed implant placement.
  • The tooth should be free of acute odontogenic infections.
  • Extraction sockets with minimal to moderate bony defect.

Exclusion Criteria:

  • Any patient who is planned for full mouth extraction.
  • Heavy smoker (more than 10 cigarettes a day).
  • History of malignancy, chemotherapy, radiation therapy.
  • Immunosuppressive disease.
  • Uncontrolled systemic disease.
  • Any contraindications to surgical procedures.
  • Females who are pregnant or breastfeeding.
  • For multi-rooted teeth, if the most coronal part of the interradicular septum is less than 5 mm below the crest of the bone.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
有源比较器:Control group
Under the effect of local anesthetic tooth will be extracted then a d-PTFE membrane will be used to cover the socket without any bone graft material to preserve the ridge.
Following tooth extraction, the socket will be covered with a d-PTFE membrane
其他名称:
  • 胞质体
实验性的:Test group
Under the effect of local anesthetic tooth extraction will be followed by the collection of about 50 ml of the patient's venous blood, then without adding any anticougulant the blood will be spun to make a plug. The Leukocyte platelet rich fibrin plug + d-PTFE membrane will be used to preserve the ridge.
Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Quality of the Newly Formed Bone
大体时间:The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).
Histomorphometric analysis will be performed on a bone core sample harvested at the time of implant placement.
The bone sample was harvested at 14 weeks from the baseline visit (extraction of tooth).

次要结果测量

结果测量
措施说明
大体时间
Dimensional Changes of the Alveolar Ridge (Ridge Width)
大体时间:The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.
Two Cone Bean Computerized Tomography (CBCT) measurements were compared to perform the analysis.
The baseline CBCT after tooth extraction and 12 weeks CBCT after extraction.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 首席研究员:Mhdfiras Al Yafi, DDS、University of Kentucky College of Dentistry

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年3月26日

初级完成 (实际的)

2020年3月30日

研究完成 (实际的)

2020年6月30日

研究注册日期

首次提交

2018年3月14日

首先提交符合 QC 标准的

2018年3月27日

首次发布 (实际的)

2018年4月4日

研究记录更新

最后更新发布 (实际的)

2021年5月24日

上次提交的符合 QC 标准的更新

2021年5月20日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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