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Enamel Matrix Derivative and Xenograft for Mandibular Molar Furcation Defects

2026年8月17日 更新者：Vy Truong Tuong Huynh、University of Medicine and Pharmacy at Ho Chi Minh City

Efficacy of Enamel Matrix Derivative Combined With Xenograft in the Treatment of Furcation Defects in Mandibular Molars

This randomized controlled clinical trial aims to compare two regenerative surgical approaches for the treatment of mandibular molar Class II furcation defects in patients with periodontitis. Eligible furcation defects will be randomly assigned to receive either xenograft bone combined with enamel matrix derivative (EMD) or xenograft bone combined with a collagen membrane. Both approaches are used to support periodontal tissue regeneration.

Participants will be followed for approximately 7 months. The study will evaluate postoperative pain and patient-reported satisfaction, periodontal clinical parameters, changes in furcation defect volume and relative bone density on cone-beam computed tomography (CBCT), and changes in gingival crevicular fluid TWEAK levels. Clinical and radiographic outcomes will be assessed before surgery and during follow-up, including at 3 and 6 months after surgery.

The study is intended to determine whether xenograft bone combined with EMD provides clinical, radiographic, biological, and patient-reported outcomes comparable or superior to xenograft bone combined with a collagen membrane in the regenerative treatment of mandibular molar Class II furcation defects.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a randomized controlled clinical trial involving patients with periodontitis who have Class II furcation defects affecting mandibular first and/or second molars. A total of 24 eligible teeth are planned, with 12 teeth assigned to each treatment group.

Before surgery, participants will undergo clinical periodontal examination, intraoral three-dimensional scanning, CBCT imaging, and gingival crevicular fluid collection. Clinical measurements include plaque index (PI), gingival index (GI), probing pocket depth (PPD), vertical clinical attachment loss (VCAL), and horizontal clinical attachment loss (HCAL).

Eligible defects will be randomly assigned to one of two regenerative surgical treatments. Following flap elevation, debridement, root surface cleaning, and conditioning with 24% EDTA, the control group will receive xenograft bone covered with a resorbable collagen membrane. The experimental group will receive enamel matrix derivative applied to the defect-related root surface, followed by xenograft bone combined with enamel matrix derivative. The flap will then be repositioned and sutured.

Postoperative pain will be assessed using a visual analog scale, together with analgesic consumption and patient-reported satisfaction regarding swelling and chewing ability. Participants will return for follow-up at approximately 2 weeks, 1 month, 3 months, and 6 months after surgery. Gingival crevicular fluid will be collected during follow-up for measurement of TWEAK concentration.

At 3 months, selected periodontal and biological assessments will be repeated. At 6 months, periodontal clinical measurements, intraoral three-dimensional scanning, furcation defect classification, and CBCT imaging will be repeated to evaluate changes in defect volume and relative bone density.

The primary purpose of the study is to compare the regenerative effectiveness of xenograft bone combined with enamel matrix derivative with that of xenograft bone combined with a collagen membrane for the treatment of mandibular molar Class II furcation defects.

研究类型

介入性

注册 (估计的)

24

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

  • 越南
    • Binh Phu
      • Ho Chi Minh City、Binh Phu、越南、700000
        • 招聘中
        • Faculty of Dentistry, University of Medicine and Pharmacy at Ho Chi Minh City
        • 接触：

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:

  • Age 18 years or older.
  • Full-mouth plaque score (FMPS) ≤ 20%.
  • Full-mouth bleeding score (FMBS) ≤ 20%.
  • Willingness to participate in the study and provide informed consent.
  • Mandibular first and/or second molar with a buccal Class II furcation defect classified as subgroup A2 or B2.
  • Probing pocket depth (PPD) ≥ 5 mm at the eligible furcation site.
  • Keratinized gingival height ≥ 2 mm at the eligible site.
  • No gingival recession extending apically beyond the buccal furcation roof; the furcation entrance must not be clinically exposed above the gingival margin.

Exclusion Criteria:

  • Systemic diseases or conditions that may affect periodontal treatment outcomes, including uncontrolled diabetes mellitus, heart disease requiring anticoagulant therapy, hematologic disorders, or immunodeficiency.
  • Pregnancy or breastfeeding.
  • Untreated endodontic pathology involving the study tooth.
  • Class III furcation involvement according to the Hamp classification.
  • Untreated occlusal trauma involving the study tooth.
  • Grade II tooth mobility that has not been stabilized by splinting, or Grade III tooth mobility according to the Miller classification.
  • Defective restorations at the surgical site, including overhanging, bulky, or poorly adapted restorations.

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：Xenograft + Enamel Matrix Derivative
程序：Periodontal Regenerative Surgery With Xenograft and Enamel Matrix Derivative
Periodontal regenerative surgery is performed using xenograft bone combined with enamel matrix derivative (EMD). After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, EMD is applied to the root surface associated with the furcation defect. The xenograft bone is mixed with EMD and placed to completely fill the defect. The flap is then repositioned and sutured.
有源比较器：Xenograft + Collagen Membrane
程序：Periodontal Regenerative Surgery With Xenograft and Collagen Membrane
Periodontal regenerative surgery is performed using xenograft bone combined with a resorbable collagen membrane. After flap elevation, thorough defect debridement, and root surface conditioning with 24% EDTA for 2 minutes, the xenograft bone is mixed with sterile saline and placed to completely fill the furcation defect. A trimmed resorbable collagen membrane is positioned to completely cover the defect and secured before flap repositioning and suturing.

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
Change in Probing Pocket Depth (PPD)
大体时间：Baseline and 6 months after surgery
Probing pocket depth (PPD) is measured in millimeters from the gingival margin to the base of the periodontal pocket using a UNC-15 periodontal probe at the mesiobuccal, buccal, and distobuccal sites of the treated tooth. Measurements are standardized using an individualized acrylic stent. The change in PPD from baseline to 6 months after surgery will be compared between the two treatment groups.
Baseline and 6 months after surgery
Change in Horizontal Clinical Attachment Loss (HCAL)
大体时间：Baseline and 6 months after surgery
Horizontal clinical attachment loss (HCAL) is measured in millimeters from the buccal entrance of the furcation to the deepest horizontal point of the furcation defect using a Nabers periodontal probe and an individualized acrylic stent.
Baseline and 6 months after surgery

次要结果测量

结果测量
措施说明
大体时间
Change in Vertical Clinical Attachment Loss (VCAL)
大体时间：Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Buccal Gingival Recession (REC)
大体时间：Baseline, 3 months, and 6 months after surgery
Baseline, 3 months, and 6 months after surgery
Change in Plaque Index (PI)
大体时间：Baseline, 3 months, and 6 months after surgery
Baseline, 3 months, and 6 months after surgery
Change in Gingival Index (GI)
大体时间：Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Furcation Defect Volume on CBCT
大体时间：Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Relative Bone Density on CBCT
大体时间：Baseline and 6 months after surgery
Baseline and 6 months after surgery
Change in Gingival Crevicular Fluid TWEAK Concentration
大体时间：Baseline, 1 month, and 3 months after surgery
Baseline, 1 month, and 3 months after surgery
Postoperative Pain Assessed by Visual Analog Scale (VAS)
大体时间：12 hours, 24 hours, and 72 hours after surgery
12 hours, 24 hours, and 72 hours after surgery
Postoperative Analgesic Consumption
大体时间：During the first 3 days after surgery
During the first 3 days after surgery
Patient Satisfaction With Postoperative Swelling
大体时间：3 and 7 days after surgery
Patient-reported satisfaction with postoperative swelling will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate better satisfaction (better outcome).
3 and 7 days after surgery
Patient Satisfaction With Chewing Ability
大体时间：3 and 7 days after surgery
Patient-reported satisfaction with chewing ability after surgery will be assessed using a 5-point Likert scale, where 1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied. Higher scores indicate better satisfaction (better outcome).
3 and 7 days after surgery

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

University of Medicine and Pharmacy at Ho Chi Minh City

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)

2026年6月29日

初级完成 (估计的)

2027年9月29日

研究完成 (估计的)

2027年9月30日

研究注册日期

首次提交

2026年8月12日

首先提交符合 QC 标准的

2026年8月17日

首次发布 (实际的)

2026年8月20日

研究记录更新

最后更新发布 (实际的)

2026年8月20日

上次提交的符合 QC 标准的更新

2026年8月17日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 26412-ĐHYD

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

不

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