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Titanium-Prepared Platelet-Rich Fibrin for Extraction Socket Healing (TPRF-SOCKET)

2026年7月14日 更新者：Hakan özdemir、Eskisehir Osmangazi University

Effect of Titanium-Prepared Platelet-Rich Fibrin on Extraction Socket Healing: A Randomized Clinical Trial Using CBCT-Based Volumetric Analysis

Alveolar ridge preservation after tooth extraction is important for maintaining bone volume and facilitating future implant placement. Titanium-prepared platelet-rich fibrin (T-PRF) is an autologous platelet concentrate that may enhance soft and hard tissue healing through the sustained release of growth factors. However, clinical evidence regarding its effect on socket healing remains limited.

The aim of this prospective randomized controlled clinical trial is to evaluate the effect of T-PRF on alveolar socket healing following tooth extraction. Participants requiring tooth extraction and subsequent implant placement are randomly assigned to either a T-PRF group or a spontaneous healing (control) group. Cone-beam computed tomography (CBCT) is used to evaluate socket healing volumetrically. The primary outcome is the percentage of socket fill and residual non-ossified socket volume after 3 months. Secondary outcomes include baseline socket volume and postoperative clinical healing.

The findings of this study are expected to provide evidence regarding the effectiveness of T-PRF in enhancing alveolar socket healing and preserving ridge dimensions before implant placement.

研究概览

地位

完全的

条件

干预/治疗

详细说明

Tooth extraction is commonly followed by physiological alveolar bone resorption, which may compromise subsequent implant placement. Alveolar ridge preservation techniques have been developed to minimize post-extraction dimensional changes. Titanium-prepared platelet-rich fibrin (T-PRF) is an autologous platelet concentrate prepared in titanium tubes without anticoagulants and has been proposed to enhance wound healing and bone regeneration through the sustained release of growth factors.

This prospective randomized controlled clinical trial was conducted at the Department of Periodontology, Eskişehir Osmangazi University. Patients requiring tooth extraction followed by implant placement were screened according to predefined inclusion and exclusion criteria and provided written informed consent before participation.

Participants were randomly allocated to either the T-PRF group or the spontaneous healing (control) group. In the intervention group, T-PRF was prepared from autologous venous blood using titanium tubes and placed into the extraction socket immediately after atraumatic tooth extraction. In the control group, extraction sockets were allowed to heal spontaneously without the use of any socket preservation material. All surgical procedures were performed by the same experienced operator, and postoperative care was standardized for all participants.

Cone-beam computed tomography (CBCT) scans were obtained approximately 10 days after extraction (baseline) and again at 3 months before implant placement. Volumetric measurements were performed using dedicated imaging software by a blinded examiner. The primary outcome was the percentage of socket fill and residual non-ossified socket volume after 3 months. Secondary outcomes included baseline socket volume and clinical healing during the postoperative period.

The results of this study will contribute to the clinical evidence regarding the effectiveness of T-PRF as a minimally invasive autologous biomaterial for enhancing extraction socket healing prior to implant placement.

研究类型

介入性

注册 (实际的)

30

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

  • 土耳其（türkiye）
      • Eskişehir、土耳其（türkiye）、26140
        • Department of Periodontology, Faculty of Dentistry, Eskişehir Osmangazi University

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

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Adults aged 18 to 65 years.
  • Systemically healthy individuals.
  • Indication for tooth extraction followed by implant placement.
  • Adequate bone volume for future implant placement without the need for advanced augmentation procedures.
  • Good oral hygiene (Plaque Index ≤1.5)
  • Ability and willingness to provide written informed consent.

Exclusion Criteria:

  • Current smokers.
  • Pregnant or breastfeeding women.
  • Uncontrolled systemic disease or diabetes mellitus.
  • Use of medications known to affect bone metabolism.
  • History of head and neck radiotherapy or chemotherapy.
  • Acute infection, periapical lesions, alveolar bone pathology, or socket defects at the extraction site.
  • Severe periodontal destruction requiring extensive augmentation procedures.
  • Inability or unwillingness to attend scheduled follow-up visits.

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：单身的

武器和干预

参与者组/臂
干预/治疗
实验性的：T-PRF Group
Participants underwent atraumatic tooth extraction followed by placement of autologous titanium-prepared platelet-rich fibrin (T-PRF) into the extraction socket. Standard postoperative care was provided, and healing was evaluated over a 3-month follow-up period.
生物：Titanium-Prepared Platelet-Rich Fibrin (T-PRF)
Autologous titanium-prepared platelet-rich fibrin (T-PRF) was prepared from the participant's venous blood collected into sterile titanium tubes without anticoagulant and centrifuged immediately after blood collection. The resulting fibrin clot was separated from the red blood cell layer, compressed into a membrane, and placed into the extraction socket immediately after atraumatic tooth extraction. The socket was then stabilized with sutures according to the study protocol.
其他名称：
  • T-PRF
无干预：Control Group
Participants underwent atraumatic tooth extraction followed by placement of autologous titanium-prepared platelet-rich fibrin (T-PRF) into the extraction socket. Standard postoperative care was provided, and healing was evaluated during a 3-month follow-up period.

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
Percentage of Socket Fill
大体时间：3 months after tooth extraction
Percentage of socket fill calculated using CBCT-based volumetric analysis by comparing the baseline socket volume with the residual non-ossified socket volume after healing.
3 months after tooth extraction
Percentage of Socket Fill
大体时间：3 months after tooth extraction
Percentage of socket fill calculated from CBCT-based volumetric measurements by comparing baseline socket volume with the residual non-ossified socket volume after 3 months.
3 months after tooth 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

Eskisehir Osmangazi University

调查人员

  • 研究主任：hakan özdemir, proffesor、Eskişehir Osmangazi University, Faculty of Dentistry, Department of Periodontology

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)

2023年3月1日

初级完成 (实际的)

2023年12月29日

研究完成 (实际的)

2023年12月29日

研究注册日期

首次提交

2026年7月14日

首先提交符合 QC 标准的

2026年7月14日

首次发布 (实际的)

2026年7月17日

研究记录更新

最后更新发布 (实际的)

2026年7月17日

上次提交的符合 QC 标准的更新

2026年7月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • ESOGU-TPRF-2023-01

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual participant data underlying the results reported in the published article, including demographic characteristics, clinical variables, and CBCT-based volumetric measurements, will be made available.

IPD 共享时间框架

Beginning 6 months after publication and ending 5 years after publication.

IPD 共享访问标准

De-identified individual participant data and the study protocol and statistical analysis plan will be available to qualified researchers who submit a methodologically sound research proposal. Requests should be directed to the corresponding author. Access will be granted after scientific review and approval of the proposal and execution of an appropriate data sharing agreement, where applicable.

IPD 共享支持信息类型

  • 研究方案

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

不

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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