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Soft Tissue Augmentation Around Dental Implants

2026年5月18日 更新者：Andrey Vasilyev

The Use of Collagen Matrices and Connective Tissue Grafts for Soft Tissue Augmentation Around Dental Implants

The goal of this study is to determine which method better increases the volume of soft tissues (gums) around dental implants: using the patient's own tissues or applying collagen matrices. The study also evaluates the safety of these methods and their impact on smile aesthetics.

The main questions it aims to answer:

Which method provides greater and more stable increase in gum thickness around the implant? Does the choice of material affect gum color (how well it matches adjacent areas)? What features of healing and cellular tissue structure are observed when using different materials?

Researchers will compare:

Autogenous connective tissue grafts (CTG) - the patient's own connective tissue grafts harvested from the palate or maxillary tuberosity Xenogeneic collagen matrices (XCM) - bioresorbable materials of animal origin (Fibro-Gide® and FibroMatrix®) that do not require harvesting the patient's own tissue

Participants will:

Undergo a surgical procedure to increase soft tissue volume in the area of implant placement (using one of four methods assigned randomly)

Attend clinic visits for follow-up examinations and assessments:

  • Before surgery
  • 3 months after surgery
  • 6 months after surgery

Undergo additional examinations:

  • 3D intraoral scanning to assess changes in tissue volume
  • Cone-beam computed tomography (CBCT) to measure gum thickness
  • Polarized-light photography to evaluate gum color
  • Collection of a small tissue sample (biopsy) for laboratory analysis of tissue structure and cellular composition

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

84

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

  • 俄罗斯
      • Moscow、俄罗斯、119021
        • Central Research Institute of Dental and Maxillofacial Surgery

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 between 21 and 75 years
  • Requirement for single dental implant placement in the mandibular molar region (replacing no more than one tooth)
  • Need for soft tissue augmentation to achieve peri-implant mucosal thickness ≥2 mm
  • Signed voluntary informed consent for treatment and research participation
  • Ability and willingness to attend all scheduled follow-up examinations for 12 months post-surgery
  • Adequate oral hygiene and commitment to maintain it throughout the study period

Exclusion Criteria:

  • Presence of systemic diseases in a decompensated stage (e.g., uncontrolled diabetes, severe cardiovascular disease)
  • Current or prior use of immunosuppressants, bisphosphonates, or high-dose corticosteroids
  • History of cancer, radiation therapy, or chemotherapy within 5 years prior to enrollment
  • Need for concurrent bone grafting or immediate implant placement following tooth extraction
  • Active periodontal disease or untreated oral infections at the time of surgery
  • Heavy smoking (>10 cigarettes/day) or inability to abstain from smoking during the healing period
  • Pregnancy or lactation
  • Known allergy to collagen, porcine/bovine products, or materials used in the study (sutures, anesthetics)
  • Participation in another clinical trial within 30 days prior to enrollment
  • Refusal to participate in any stage of the study or inability to comply with study procedures
  • Psychological or social conditions that, in the investigator's judgment, may compromise protocol adherence or data reliability

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：Palate CTG
Subepithelial connective tissue graft harvested from the hard palate, placed at the implant site to augment soft tissue thickness and volume
程序：Connective Tissue Graft (Palate)
Autogenous subepithelial connective tissue graft harvested from the hard palate (premolar-molar region) using a horizontal incision 2-3 mm apical to the gingival margin. Epithelium removed microscopically. Graft secured within a soft-tissue "envelope" at the recipient implant site using U-shaped sutures. Donor site closed with compression sutures.
实验性的：Tuberosity CTG
Subepithelial connective tissue graft harvested from the maxillary tuberosity, placed at the implant site to augment soft tissue thickness and volume
程序：Connective Tissue Graft (Tuberosity)
Autogenous subepithelial connective tissue graft harvested from the maxillary tuberosity using parallel incisions 2 mm distal to the last molar. Epithelial strip removed. Graft placed and secured at the implant site using U-shaped suturing technique. Donor site closed with interrupted sutures.
实验性的：Fibro-Gide
Xenogeneic collagen matrix (porcine-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue
设备：Fibro-Gide Collagen Matrix
Porcine-derived xenogeneic collagen matrix (types I/III), 6 mm thick, gamma-sterilized. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required.
实验性的：FibroMatrix
Xenogeneic collagen matrix (bovine pericardium-derived, types I/III collagen), trimmed and placed between the flap and bone to augment soft tissue
设备：FibroMatrix Collagen Matrix
Bovine pericardium-derived xenogeneic collagen matrix (types I/III), 3-4 mm thick, freeze-dried, bilayer structure. Trimmed to fit recipient site, placed between flap and bone without suturing to the flap, fully covered by soft tissues during closure. No donor site required.

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 peri-implant soft tissue thickness from baseline to 6 months post-augmentation
大体时间：Baseline (pre-surgery), 3 months post-surgery, and 6 months post-surgery
The primary outcome is the mean change in vertical soft tissue thickness at the implant site, measured at three equidistant points (crest, 1 mm apical, 2 mm apical) along the vestibular aspect of the alveolar ridge. Thickness is assessed using three complementary methods: (1) mucosal puncture with a calibrated spreader and silicone stopper under local anesthesia; (2) superimposition of cone-beam computed tomography (CBCT) scans; and (3) comparison of digital 3D intraoral scans (STL files) using GOM Inspect software. Measurements are averaged across the three points per site. The primary analysis compares mean thickness gain between the four intervention groups (palate CTG, tuberosity CTG, Fibro-Gide, FibroMatrix) at 6 months.
Baseline (pre-surgery), 3 months post-surgery, and 6 months post-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

Andrey Vasilyev

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)

2021年10月1日

初级完成 (实际的)

2024年10月1日

研究完成 (实际的)

2024年10月1日

研究注册日期

首次提交

2026年5月18日

首先提交符合 QC 标准的

2026年5月18日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月18日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他研究编号

  • 1/20

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 (IPD) will not be shared publicly. This decision is based on: (1) the single-center, academic nature of the study with a relatively small sample size, which increases re-identification risk even after de-identification; (2) the inclusion of detailed clinical, radiographic, and histological data that may contain sensitive personal health information; (3) ongoing secondary analyses and manuscript preparations by the investigative team; and (4) the absence of a dedicated infrastructure for secure, governed data sharing at this institution.

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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