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根据移植物的位置,使用改良的冠状先进隧道和上皮下结缔组织移植物治疗多发性牙龈退缩的评估

2026年4月21日 更新者:Medical University of Warsaw
使用上皮下结缔组织移植物 (sCTG) 的显微冠状先进隧道手术可预测治愈多个相邻的 1 型和 2 型牙龈退缩(RT1 和 RT2)。 为了降低患者发病率并增强牙周伤口愈合,可以使用 sCTG。 本研究的目的是比较改良隧道技术与上皮下结缔组织移植物在牙龈退缩中的结果,其中内侧朝向瓣盖移植物,外侧朝向瓣盖移植物。

研究概览

详细说明

病情或疾病:多发性牙龈退缩

干预/治疗:

装置:改良的冠状先进隧道,带有结缔组织移植物,内侧朝向皮瓣 装置:改良的冠状先进隧道,带有上皮下结缔组织移植物,外侧朝向皮瓣 阶段:不适用

研究类型

介入性

注册 (实际的)

21

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

    • MAzowsze
      • Warsaw、MAzowsze、波兰、00-246
        • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

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

接受健康志愿者

不

描述

纳入标准:

  • 年龄≥18岁
  • 同一牙弓的同源牙齿双侧多处牙龈退缩。

排除标准:

  • 全口牙菌斑指数 ≥ 20% (Ainamo & Bay 1975)
  • 全口龈沟出血指数 ≥ 15% (Mühlemann & Son 1971)
  • 抽烟
  • 感染性疾病治愈潜力受损的全身性疾病
  • 影响牙周健康/愈合的药物
  • 怀孕及哺乳期女性
  • 该区域既往接受过牙周手术

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:The tunnel technique for root coverage with CTG with outer side of the graft

Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.

21 participants were enrolled into the study, as it was designed to be a split mouth study

Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the outer side of the graft faces the inner surface of the flap. The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
实验性的:The tunnel technique for root coverage with CTG with inner side of the graft

Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures.

21 participants were enrolled into the study, as it was designed to be a split mouth study.

Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG). A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions. The CTG will be inserted into the tunnel and positioned so that the inner (deep) side of the graft faces the inner surface of the flap (standardized graft orientation). The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.

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
Percent Change in Gingival Recession (Mean Root Coverage, MRC)
大体时间:Baseline and 6 months after surgery

Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%.

  • GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side
  • GR0- before surgery
  • GR6- 6 months after surgery
Baseline and 6 months after surgery

次要结果测量

结果测量
措施说明
大体时间
GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
大体时间:6 months after surgery

The analyzed metrics were calculated as follows:

GR change= GR0-GR6 (after 6 months); ) [millimetre] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); [millimetre] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); [millimetre] higher scores mean better outcome

  • GR-gingival recession height: distance between the cementoenamel junction (CEJ) and the gingival margin at the mid-buccal side
  • GT- gingival thickness
  • KTW- distance between the gingival margin and the muco-gingival junction (MGJ)
  • 0- before surgery
  • 6- 6 months after surgery
6 months after surgery

其他结果措施

结果测量
措施说明
大体时间
Root Coverage Esthetic Score (RES)
大体时间:6 months after surgery

RES:The following variables were assessed:

  1. GM - assessment rule: 0 points- root coverage failure, 3 points- partial root coverage, 6 points- complete root coverage;
  2. marginal tissue contour (MTC) - assessment rule: 0 points - irregular gingival margin, not in line with the CEJ, 1 point- scalloped gingival contour, in line with the CEJ;
  3. soft tissue texture (STT) - assessment rule: 0 points - scar formation, 1 point- absence of scars;
  4. MGJ - assessment rule: 0 points - MGJ not aligned with the MGJ of adjacent teeth, 1 point- MGJ aligned with the MGJ of adjacent teeth;
  5. gingival color (GC) - assessment rule: 0 points- color does not match adjacent teeth, 1 point- color matches adjacent teeth The maximum score for RES was 10, the minimum 0. Higher scores mean better outcome.
6 months 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。

调查人员

  • 首席研究员:Bartłomiej Górski, PhD、Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw

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)

2024年5月30日

初级完成 (实际的)

2024年11月30日

研究完成 (实际的)

2025年11月30日

研究注册日期

首次提交

2024年4月10日

首先提交符合 QC 标准的

2024年4月10日

首次发布 (实际的)

2024年4月15日

研究记录更新

最后更新发布 (实际的)

2026年5月14日

上次提交的符合 QC 标准的更新

2026年4月21日

最后验证

2025年11月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • Warsaw.06

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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