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Effect of Collagen Membrane on Ridge Preservation

2026年6月2日 更新者：Debora Dias

Effect of Collagen Membrane on Ridge Preservation for Delayed Implant Placement in Sites With Absent Buccal Bone Wall: A Randomized Controlled Trial

This study will evaluate whether adding a resorbable collagen membrane to an anorganic bone-collagen composite (ABCC) graft improves ridge preservation after tooth extraction. Ridge preservation is a procedure used to maintain the shape and volume of the jawbone following tooth removal, which is important for future dental implant placement.

Participants will be randomly assigned to receive either ABCC alone or ABCC combined with a collagen membrane. Healing outcomes will be assessed after approximately 4 months using three-dimensional cone beam computed tomography (CBCT) scans.

The primary outcome is the change in horizontal ridge dimension (width). Secondary outcomes include vertical and contour changes in ridge dimensions, changes in soft tissue contour assessed with digital scans, postoperative healing and complications (such as wound dehiscence, swelling, or infection), and patient-reported outcomes, including pain and satisfaction. In a subset of participants, bone healing will also be evaluated using laboratory and imaging analyses of bone samples obtained at the time of implant placement. The study will additionally assess whether the treatment allows implant placement in the ideal position without the need for further bone grafting.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This study is a clinical trial that evaluates two different approaches to preserve the jawbone after tooth extraction in areas where part of the bone is already missing. Preserving the bone is important to support future dental implants.

Participants will be randomly assigned (like flipping a coin) to receive one of two treatments: a bone graft material alone, or the same bone graft combined with a protective collagen membrane placed over it.

Tooth extraction and follow-up care will be performed in the same manner for all participants. After approximately 4 months of healing, participants will return for dental implant placement.

During the healing period and at the time of implant placement, the research team will evaluate how well the bone and gums have healed. This will include three-dimensional CBCT scans, digital intraoral scans, and clinical measurements. In some participants, a small sample of bone will be collected at the time of implant placement to study bone healing.

The study will compare how effectively each treatment maintains the shape and volume of the jawbone, the quality of soft tissue healing, the risk of complications, patient-reported outcomes (PROs), including comfort and satisfaction, and whether additional procedures are required prior to implant placement.

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：Carla Sanchez, MS
  • 电话号码：4126241179
  • 邮箱：cab28@pitt.edu

研究联系人备份

学习地点

  • 美国
    • Pennsylvania
      • Pittsburgh、Pennsylvania、美国、15213
        • 招聘中
        • University of Pittsburgh School of Dental Medicine, Department of Periodontics and Preventive Dentistry
        • 接触：
        • 首席研究员：
          • Debora R Dias, DDS, PhD
        • 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:

  • Adults aged 18-80
  • Indicated for extraction of a single-rooted maxillary tooth
  • ≥ 50% buccal bone dehiscence confirmed by CBCT reconstructions
  • Presence of both adjacent teeth
  • No interproximal bone loss
  • ASA I-II health status
  • Ability to comply with required procedures, including attending required number of clinic visits

Exclusion Criteria:

  • Patients diagnosed with periodontitis adjacent to the area to be treated
  • History of allergic reactions to local anesthetics or bone graft material (self-reported);
  • Current heavy smokers (≥ 10 cigarettes/day) or those who quit smoking recently (self-reported; last 6 months);
  • Diagnosis of diabetes mellitus, liver or kidney failure (self-reported);
  • Presence of active infectious diseases of any kind;
  • History of chemotherapy or radiation therapy to the head or neck within the past 5 years (self-reported);
  • Severe hematologic disorders (risk for hemorrhage)(self-reported);
  • Assumption of corticosteroids, IV bisphosphonates or immunosuppressive drugs;
  • Any history of alcohol or drug abuse (self-reported);
  • Pregnancy or plans to become pregnant within 4 months of study enrollment (self-reported);

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：双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器：Control group (bone graft only)
Control group (bone graft only): The socket will be grafted with ABCC alone. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress polytetrafluoroethylene sutures (PTFE) without attempting primary closure.
程序：Minimally Invasive tooth extraction
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
设备：Alveolar ridge preservation with ABCC
The extraction socket will be grafted with ABCC (SigmaGraft®).
实验性的：Test group (bone graft + collagen membrane)
Test group (bone graft + collagen membrane): A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate the resorbable collagen membrane (InterCollagen® Guide, SigmaGraft). The socket will then be grafted with ABCC. The socket entrance will be covered with a collagen sponge, which will be secured with passive cross-mattress PTFE sutures without attempting primary closure.
程序：Minimally Invasive tooth extraction
Tooth extraction will be performed by a calibrated periodontist using a minimally invasive, flapless, atraumatic technique with periotomes and elevators to preserve socket architecture. Granulation tissue will be carefully removed without flap elevation.
设备：Alveolar ridge preservation with ABCC
The extraction socket will be grafted with ABCC (SigmaGraft®).
设备：Resorbable collagen membrane (InterCollagen® Guide)
A buccal pouch will be created on the buccal aspect, between the bone and the buccal flap, using tunneling instruments to accommodate a resorbable collagen membrane (InterCollagen® Guide; SigmaGraft®). The membrane will be positioned in the buccal tunnel to replace the missing buccal bone wall and provide graft containment.

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
Horizontal dimensional changes (%)
大体时间：Baseline and 4 months
Change in horizontal ridge width at 3 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months

次要结果测量

结果测量
措施说明
大体时间
Horizontal dimensional changes (%)
大体时间：Baseline and 4 months
Change in horizontal ridge width at 1 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Horizontal dimensional changes (%)
大体时间：Baseline and 4 months
Change in horizontal ridge width at 5 mm apical to the crest, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Vertical dimensional changes (%)
大体时间：Baseline and 4 months
Change in vertical ridge height at the midbuccal aspect, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Vertical dimensional changes (%)
大体时间：Baseline and 4 months
Change in vertical ridge height at the mid palatal aspect, measured on CBCT scans and expressed in percentage change.
Baseline and 4 months
Volumetric dimensional changes (%)
大体时间：Baseline and 4 months
Change in the volume of the alveolar process (mm3), measured on CBCT scans in comparison to baseline and expressed in percentage change.
Baseline and 4 months
Mid-buccal soft tissue contour change (mm)
大体时间：Baseline and 4 months
Linear measurement (mm) of mid-buccal soft tissue profile change assessed by superimposition of stereolithography (STL) datasets. Adjacent teeth are used as reference for alignment. A positive value indicates soft tissue gain; a negative value indicates recession.
Baseline and 4 months
Mid-buccal soft tissue volume change (%)
大体时间：Baseline and 4 months
Volumetric change (mm³) in mid-buccal soft tissue contour calculated by superimposition of STL datasets and expressed in percentage. Color-coded deviation maps will illustrate areas of soft tissue collapse or gain.
Baseline and 4 months
Interproximal papilla height change (mm)
大体时间：Baseline and 4 months
Linear measurement (mm) of interproximal papilla height change assessed by superimposition of STL datasets in comparison to baseline. A positive value indicates papilla gain; a negative value indicates papilla loss.
Baseline and 4 months
Wound healing (Wound Healing Index)
大体时间：1 week, 2 weeks, 1 month, 4 months
Wound healing quality assessed using the Wound Healing Index (WHI), a 3-point ordinal scale where 1 = uneventful healing (complete soft tissue coverage, no complications), 2 = normal healing with minor complications, and 3 = poor healing (dehiscence, exposure, or infection requiring intervention). Lower scores indicate better healing.
1 week, 2 weeks, 1 month, 4 months
Incidence of postoperative complications (Percentage)
大体时间：1 week, 2 weeks, 1 month, 4 months
Proportion of participants experiencing at least one postoperative complication (edema, erythema, suppuration, graft exposure, or wound dehiscence) at any follow-up visit. Complications will be recorded by a blinded clinical examiner at each scheduled visit.
1 week, 2 weeks, 1 month, 4 months
Postoperative pain
大体时间：Day 1, Day 3, 1 week
Numeric scale (0-10) for pain after the extraction and ridge preservation procedure.
Day 1, Day 3, 1 week
Oral health-related quality of life (OHIP-14)
大体时间：Baseline, 2 weeks, 4 months
Oral health-related quality of life assessed using the Oral Health Impact Profile - 14 (OHIP-14), a validated 14-item questionnaire.
Baseline, 2 weeks, 4 months
Feasibility of prosthetically ideal implant placement without additional augmentation
大体时间：4 months
Ability to place the implant in a prosthetically ideal three-dimensional position at reentry without the need for additional hard-tissue augmentation.
4 months
Histological Outcomes
大体时间：4 months
In a subset of patients, a bone core biopsy will be obtained. Percent area of new bone, residual graft, and marrow spaces assessed by histomorphometric analysis of bone core biopsies obtained at the time of implant placement.
4 months
Patient satisfaction (VAS)
大体时间：4 months
Visual analogue scale (0-100) of patient satisfaction with the appearance of the soft tissues
4 months

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

Debora Dias

合作者

SigmaGraft Inc.

调查人员

  • 首席研究员：Debora R Dias, DDS, PhD、University of Pittsburgh, Department of Periodontics and Preventive Dentistry

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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5月26日

初级完成 (估计的)

2027年10月31日

研究完成 (估计的)

2027年10月31日

研究注册日期

首次提交

2026年4月10日

首先提交符合 QC 标准的

2026年5月6日

首次发布 (实际的)

2026年5月12日

研究记录更新

最后更新发布 (实际的)

2026年6月4日

上次提交的符合 QC 标准的更新

2026年6月2日

最后验证

2026年6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

  • STUDY25080006

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

Individual participant data will not be shared outside the primary research group due to concerns regarding participant privacy and confidentiality, as approved by the University of Pittsburgh Institutional Review Board.

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

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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