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Comparison of Autologous Tooth and Bovine Xenograft in Periodontal Healing After Mandibular Third Molar Extraction

2026年9月11日 更新者：Miguel Ruiz Rincón、Universidad Complutense de Madrid

Evaluation of Changes in Probing Depth Following Surgical Extraction of Mandibular Third Molars Using Particulated Autologous Tooth vs. Particulated Bovine Xenograft vs. Blood Clot: A Randomized Clinical Trial

This study investigates the healing of periodontal defects on the distal surface of the second lower molars after the surgical extraction of impacted third molars. Specifically, it compares the effectiveness of autologous tooth graft particles (derived from the extracted third molar) with bovine xenograft particles, using blood clot healing as a control.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This study investigates the healing of periodontal defects on the distal surface of the second lower molars after the surgical extraction of impacted third molars. Specifically, it compares the effectiveness of autologous tooth graft particles (derived from the extracted third molar) with bovine xenograft particles, using blood clot healing as a control.

Lower third molars are the most frequently impacted teeth, and their extraction can sometimes lead to or worsen periodontal defects on the adjacent second molar. Previous studies have shown positive outcomes using various bone regeneration materials; however, autologous tooth grafts have recently emerged as a biocompatible, osteoconductive, and osteoinductive alternative with promising results. Despite this, there are no clinical studies directly comparing autologous tooth grafts and bovine xenografts in this context-justifying the present research.

A prospective, randomized split-mouth clinical trial with three arms will be conducted at the Complutense University of Madrid. Each patient will undergo bilateral lower third molar extractions under three conditions:

Group A (Test 1): socket filled with autologous tooth graft,

Group B (Test 2): socket filled with bovine xenograft,

Group C (Control): socket left to heal naturally with a blood clot.

The main objective is to evaluate the reduction in probing depth on the distal surface of the second molar six months post-extraction.

Secondary outcomes include postoperative pain, inflammation, trismus, complications, wound healing, and patient-reported outcomes (PoSSe questionnaire).

Approximately 30 patients will be included, with triple randomization (side of first extraction, use of graft, and graft type). Clinical and radiographic evaluations will be performed preoperatively, and follow-ups will occur at 48 hours, one week, three months, and six months.

The null hypothesis (H₀) states that there will be no periodontal differences between the two graft materials, while the alternative hypothesis (H₁) proposes superior periodontal outcomes with the autologous tooth graft compared to the bovine xenograft.

研究类型

介入性

注册 (估计的)

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。

学习联系方式

  • 姓名：Miguel Ruiz Rincón, DDS
  • 电话号码：+34 680276072
  • 邮箱：migrui02@ucm.es

学习地点

  • 西班牙
    • Madrid
      • Madrid、Madrid、西班牙、28040
        • 招聘中
        • Postgrado de especialización en cirugía bucal e implantología, Facultad de Odontología, Universidad Complutense de Madrid
        • 接触：
          • Miguel Ruiz Rincón, DDS
          • 电话号码：+34 680 27 60 72
          • 邮箱：migrui02@ucm.es

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

是的

描述

Inclusion Criteria:

  • Adults (≥18 years old) of any sex, able to understand and follow study instructions.
  • Patients requiring bilateral surgical extraction of impacted lower third molars in horizontal or mesioangular position.
  • Presence of both lower second molars.
  • Classified as ASA I or ASA II (according to the American Society of Anesthesiologists).
  • Willingness to participate voluntarily and sign informed consent.

Exclusion Criteria:

  • Age under 18 years.
  • ASA physical status III, IV, V, or VI.
  • Pregnant or breastfeeding women.
  • Immunosuppressed patients.
  • Current treatment with NSAIDs, anticoagulants, or acetylsalicylic acid.
  • Previous or current treatment with bisphosphonates.
  • Presence of oral dysplasia or precancerous lesions.

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：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Autologous Tooth Graft (Test 1)
After surgical extraction of the impacted lower third molar, the socket will be filled with autologous tooth graft particles obtained from the extracted tooth using the Smart Dentin Grinder®. The graft particles (300-1200 µm) will be decontaminated, rinsed, and placed on the distal surface of the second molar. The graft will be covered with a resorbable hemostatic sponge (Roeko Gelatamp®) before suturing.
生物：Autologous Tooth Graft
Autologous tooth graft particles are prepared from the extracted third molar using the Smart Dentin Grinder®. The tooth is cleaned, dried, and ground to particles of 300-1200 µm, decontaminated with 0.5 M sodium hydroxide and 20% ethanol, rinsed with sterile saline, and placed on the distal surface of the second molar. The graft is covered with a resorbable hemostatic sponge (Roeko Gelatamp®) prior to wound closure.
其他名称：
  • Smart Dentin Grinder®
有源比较器：Bovine Xenograft (Test 2)
After extraction of the impacted lower third molar, the socket will be filled with particulate bovine xenograft (InterOss®) hydrated in sterile saline. The material will be placed on the distal surface of the second molar and covered with a resorbable hemostatic sponge before suturing.
生物：Autologous Tooth Graft
Autologous tooth graft particles are prepared from the extracted third molar using the Smart Dentin Grinder®. The tooth is cleaned, dried, and ground to particles of 300-1200 µm, decontaminated with 0.5 M sodium hydroxide and 20% ethanol, rinsed with sterile saline, and placed on the distal surface of the second molar. The graft is covered with a resorbable hemostatic sponge (Roeko Gelatamp®) prior to wound closure.
其他名称：
  • Smart Dentin Grinder®
无干预：Blood Clot (Control)
Following extraction of the impacted lower third molar, the socket will be left to heal naturally through blood clot formation, without placement of any graft material or hemostatic sponge. Standard wound closure and postoperative care will be provided.

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
Reduction in probing depth on the distal surface of the mandibular second molar
大体时间：Baseline (preoperative), 3 months, and 6 months post-extraction
Periodontal probing depth (in millimeters) measured on the distal surface of the lower second molar using a calibrated periodontal probe (CP12). The reduction in probing depth will be compared among the three groups (autologous tooth graft, bovine xenograft, and blood clot control) to evaluate periodontal healing following extraction of the lower third molars.
Baseline (preoperative), 3 months, and 6 months post-extraction

次要结果测量

结果测量
措施说明
大体时间
Postoperative swelling
大体时间：Preoperative, 48 hours, and 7 days post-extraction
Facial swelling measured as the linear distance between anatomical landmarks (tragus-commissure, tragus-gonion, and gonion-commissure) using a suture thread and caliper.
Preoperative, 48 hours, and 7 days post-extraction
Postoperative trismus
大体时间：Preoperative, 48 hours, and 7 days post-extraction
Maximum interincisal mouth opening measured in millimeters using a caliper.
Preoperative, 48 hours, and 7 days post-extraction
Wound healing quality
大体时间：48 hours, and 7 days post-extraction
linical evaluation of the surgical site according to Blum's criteria (good, acceptable, poor), based on mucosal color, bleeding, wound margins, and closure.
48 hours, and 7 days post-extraction
Patient-reported quality of life
大体时间：7 days post-extraction
Assessed using the Postoperative Symptom Severity (PoSSe) scale, covering pain, function, daily activities, and social interaction after surgery.
7 days post-extraction

其他结果措施

结果测量
措施说明
大体时间
Surgical time
大体时间：Intraoperatively
Minutes and seconds recorded intraoperatively
Intraoperatively
Surgical difficulty
大体时间：Intraoperatively
Classified according to the modified Parant scale: Types I-IV
Intraoperatively

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

Universidad Complutense de Madrid

合作者

Bioner

调查人员

  • 研究主任：José María Martínez-González, MD,DMD,PhD,MDV、Department of Dental Clinical Specialties, Faculty of Dentistry, Complutense University of Madrid

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)

2025年9月1日

初级完成 (估计的)

2026年9月30日

研究完成 (估计的)

2026年9月30日

研究注册日期

首次提交

2026年9月11日

首先提交符合 QC 标准的

2026年9月11日

首次发布 (实际的)

2026年9月17日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月11日

最后验证

2025年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • 25/636-EC_X

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

Individual participant data (IPD) from this study will be shared with qualified researchers after the publication of primary results. Shared data will include anonymized measurements of periodontal probing depth, postoperative outcomes (pain, swelling, trismus), PoSSe questionnaire responses, and relevant demographic and clinical variables. Data will be de-identified to protect participant confidentiality.

IPD 共享时间框架

IPD will be available beginning 6 months after publication of the primary study results and will remain accessible for 5 years.

IPD 共享访问标准

Data will be available to researchers who submit a written request describing the purpose of the analysis and who agree to a data use agreement ensuring confidentiality and appropriate use. Requests will be reviewed by the Principal Investigator or designated study committee.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 分析代码
  • 企业社会责任

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

在美国制造并从美国出口的产品

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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