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Volume-Stable Collagen Matrix Versus Subepithelial Connective Tissue Graft for Multiple Gingival Recessions (VCMX-SCTG)

2026年8月22日 更新者：Arthur Belem Novaes Jr、University of Sao Paulo

Volume-Stable Xenogeneic Collagen Matrix Versus Subepithelial Connective Tissue Graft for the Treatment of Multiple Gingival Recessions: A 12-Month Randomized Controlled Clinical Trial

Gingival recession is a clinical condition in which the gingival margin is displaced apically, exposing the root surface. This condition may be associated with esthetic concerns, dentin hypersensitivity, and difficulties in oral hygiene. Subepithelial connective tissue grafting is considered a standard surgical approach for root coverage, but it requires harvesting tissue from the palate, which may increase postoperative discomfort. Volume-stable xenogeneic collagen matrices have been proposed as an alternative biomaterial to reduce the need for a palatal donor site.

This randomized controlled clinical trial will compare a volume-stable xenogeneic collagen matrix with an autogenous subepithelial connective tissue graft for the treatment of multiple gingival recessions. Participants will be allocated to one of two treatment groups. The test group will receive root coverage surgery using a volume-stable collagen matrix, while the control group will receive root coverage surgery using a subepithelial connective tissue graft. Clinical, patient-reported, esthetic, and digital outcomes will be assessed at baseline and during follow-up visits up to 12 months.

The primary outcome will be the change in gingival recession depth from baseline to 12 months. Secondary outcomes will include keratinized tissue width, gingival thickness, percentage of root coverage, complete root coverage, dentin hypersensitivity, patient-reported satisfaction, early wound healing, and digital volumetric changes assessed by intraoral scanning.

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This study is a randomized controlled clinical trial designed to evaluate the clinical performance of a volume-stable xenogeneic collagen matrix compared with an autogenous subepithelial connective tissue graft in the treatment of multiple gingival recessions.

Eligible participants presenting multiple gingival recessions will be recruited and allocated to one of two parallel treatment groups. In the test group, participants will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap. In the control group, participants will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap.

Clinical assessments will include gingival recession depth, keratinized tissue width, probing depth, clinical attachment level, gingival thickness, percentage of root coverage, and complete root coverage. Patient-reported outcomes will include dentin hypersensitivity, postoperative comfort, esthetic satisfaction, and acceptance of the procedure. Standardized clinical photographs and intraoral scans will be obtained during follow-up. Digital analyses will be used to assess changes in soft tissue volume over time.

The primary endpoint will be the change in gingival recession depth from baseline to 12 months. Secondary endpoints will include clinical, esthetic, patient-reported, wound healing, and digital volumetric outcomes assessed at predefined follow-up visits.

研究类型

介入性

注册 (估计的)

40

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

研究联系人备份

学习地点

  • 巴西
    • São Paulo
      • Ribeirão Preto、São Paulo、巴西、14040-904
        • School of Dentistry of Ribeirão Preto, University of Sao Paulo
        • 接触：
        • 接触：
        • 首席研究员：
          • Arthur Belem Novaes Jr, DDS, PhD
        • 副研究员：
          • Edgar Daniel Vargas Quiroga, DDS, MSc

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 years or older.
  • Presence of at least two Cairo RT1 gingival recessions in anterior teeth and/or premolars.
  • Gingival recession depth greater than or equal to 2 mm.
  • Presence of at least 2 mm of keratinized gingiva apical to the gingival recession.
  • Indication for root coverage treatment due to esthetic concern and/or dentin hypersensitivity.
  • Sites with non-carious cervical lesions may be included if they are previously restored and, after restoration, present residual gingival recession greater than or equal to 2 mm.
  • Good plaque control, defined as full-mouth plaque score and full-mouth marginal gingival bleeding score below 20%.

Exclusion Criteria:

  • Current smokers or individuals who stopped smoking less than 12 months before enrollment.
  • Decompensated systemic diseases.
  • Pregnancy or lactation.
  • Active periodontal disease.
  • Untreated root caries.
  • Previous mucogingival surgery in the study area.

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：Volume-Stable Collagen Matrix
Participants in this group will receive root coverage surgery using a volume-stable xenogeneic collagen matrix associated with a coronally advanced flap.
设备：Volume-stable xenogeneic collagen matrix (VCMX)
A volume-stable xenogeneic collagen matrix will be used as a soft-tissue substitute for root coverage surgery. The matrix will be placed over the recession defects and covered by a coronally advanced flap.
其他名称：
  • VCMX
  • Fibro-Gide
有源比较器：Subepithelial Connective Tissue Graft
Participants in this group will receive root coverage surgery using an autogenous subepithelial connective tissue graft associated with a coronally advanced flap.
程序：Subepithelial connective tissue graft (SCTG)
An autogenous subepithelial connective tissue graft will be harvested from the palate and used for root coverage surgery. The graft will be placed over the recession defects and covered by a coronally advanced flap.
其他名称：
  • SCTG

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
Gingival Recession Depth
大体时间：Baseline, 3 months, 6 months, and 12 months
Gingival recession depth will be measured clinically in millimeters as the distance from the cementoenamel junction to the gingival margin. The main comparison between groups will be performed at 12 months.
Baseline, 3 months, 6 months, and 12 months

次要结果测量

结果测量
措施说明
大体时间
Gingival Recession Width
大体时间：Baseline, 3 months, 6 months, and 12 months
Gingival recession width will be measured horizontally in millimeters at the level of the cementoenamel junction.
Baseline, 3 months, 6 months, and 12 months
Keratinized Tissue Width
大体时间：Baseline, 3 months, 6 months, and 12 months
Keratinized tissue width will be measured in millimeters from the gingival margin to the mucogingival junction.
Baseline, 3 months, 6 months, and 12 months
Gingival Thickness
大体时间：Baseline, 3 months, 6 months, and 12 months
Gingival thickness will be measured in millimeters at the treated sites using a standardized clinical method.
Baseline, 3 months, 6 months, and 12 months
Probing Depth
大体时间：Baseline, 3 months, 6 months, and 12 months
Probing depth will be measured in millimeters from the gingival margin to the bottom of the sulcus or pocket at the treated sites.
Baseline, 3 months, 6 months, and 12 months
Clinical Attachment Level
大体时间：Baseline, 3 months, 6 months, and 12 months
Clinical attachment level will be calculated in millimeters as probing depth plus gingival recession depth.
Baseline, 3 months, 6 months, and 12 months
Percentage of Root Coverage
大体时间：3 months, 6 months, and 12 months
Percentage of root coverage will be calculated based on the reduction in gingival recession depth from baseline to 12 months.
3 months, 6 months, and 12 months
Complete Root Coverage
大体时间：3 months, 6 months, and 12 months
Complete root coverage will be defined as the absence of residual gingival recession at the treated site.
3 months, 6 months, and 12 months
Dentin Hypersensitivity
大体时间：Baseline, 3 months, 6 months, and 12 months
Will be assessed after standardized air stimulation using a 0 to 100 visual analog scale. A score of 0 indicates no pain or sensitivity, and a score of 100 indicates the worst imaginable pain or sensitivity. Higher scores indicate worse dentin hypersensitivity.
Baseline, 3 months, 6 months, and 12 months
Patient-Reported Esthetic Satisfaction
大体时间：Baseline, 3 months, 6 months, and 12 months
Patient-reported esthetic satisfaction will be assessed using a 0 to 100 visual analog scale. A score of 0 indicates complete dissatisfaction, and a score of 100 indicates complete satisfaction. Higher scores indicate better esthetic satisfaction.
Baseline, 3 months, 6 months, and 12 months
Digital Volumetric Changes
大体时间：Baseline, 3 months, 6 months, and 12 months
Soft tissue volumetric changes will be assessed using intraoral scans and digital superimposition of three-dimensional Standard Tessellation Language (STL) models.
Baseline, 3 months, 6 months, and 12 months
Early Wound Healing
大体时间：7 days, 14 days, and 30 days
Early wound healing will be assessed clinically during the postoperative period based on flap margin adaptation, suture stability, edema, inflammation, erythema, fibrin accumulation, tissue necrosis, epithelialization, biomaterial or graft exposure, and overall wound healing pattern.
7 days, 14 days, and 30 days

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 Sao Paulo

调查人员

  • 首席研究员：Arthur Belem Novaes Jr, DDS, PhD、University of Sao Paulo
  • 学习椅：Edgar Daniel Vargas Quiroga, DDS, MSc、University of Sao Paulo

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 (估计的)

2026年10月1日

初级完成 (估计的)

2028年10月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年5月21日

首先提交符合 QC 标准的

2026年5月21日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年8月25日

上次提交的符合 QC 标准的更新

2026年8月22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

  • CAAE 98199226.9.0000.5419 (其他标识符：Plataforma Brasil / Brazilian CEP-CONEP System)

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 because the study involves clinical data, photographs, and intraoral scans that may increase the risk of participant identification. Results will be reported in aggregate form.

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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