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Apical Flap Repositioning vs. Mucosa Excision With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation (FGGIF)

2026年8月15日 更新者：Octavi Camps-Font、University of Barcelona

Multicenter Randomized Clinical Trial Comparing Apical Flap Repositioning Versus Vestibular Mucosa Excision Associated With Free Gingival Grafts for Peri-Implant Keratinized Mucosa Augmentation

The goal of this clinical trial is to learn which surgical technique works better to increase the amount of firm gum tissue (called keratinized mucosa) around dental implants in adults.

The main question it aims to answer is:

-Does repositioning the gum flap upward with stitches lead to a greater gain in firm gum tissue width at 6 months compared to simply removing the extra gum tissue, when both techniques are combined with a free gum graft?

Researchers will compare two techniques used during the second stage of implant surgery to see which one produces a greater gain in firm gum tissue around the implant.

Participants will:

  • Receive a free gum graft (a small piece of tissue taken from the roof of the mouth) placed around their dental implant during a routine surgical visit
  • Be randomly assigned to one of the two surgical techniques
  • Have digital scans of their mouth taken at 5 timepoints over 6 months
  • Complete a pain diary and answer questions about their experience during the first week after surgery
  • Attend follow-up visits at 6 weeks, 3 months, and 6 months after surgery

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

This superiority multicenter randomized clinical trial is coordinated by the Universitat de Barcelona (UB) and includes the Universidad Complutense de Madrid (UCM) as a collaborating center.

Participant selection Adults with osseointegrated implants in the posterior maxilla or mandible presenting keratinized mucosa width of 2 mm or less and/or vestibular depth less than 4 mm will be screened for eligibility. Participants must be in periodontal and peri-implant health and have a plaque index of 15% or less.

Randomization Eligible participants will be randomly assigned (1:1) to one of two treatment groups using an Interactive Web Response System (IWRS) provided by Sealed Envelope Ltd. Randomization will take place intraoperatively, once the partial-thickness mucosal flap has been prepared.

Interventions

Group 1 (Control): Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum Group 2 (Experimental): Free gingival graft with excision of the vestibular mucous tissue

Outcome assessment Soft tissue changes will be assessed at 5 timepoints (T0, Tim, T6w, T3m, T6m) using intraoral scans (TRIOS 3®, 3Shape) analyzed with Geomagic Control X® software through three-dimensional digital superimposition. Clinical measurements will also be performed using a calibrated periodontal probe and a customized thermoplastic stent to standardize the measurement point across visits.

Participants will complete a pain diary during the first 7 postoperative days recording pain intensity (100 mm visual analogue scale), analgesic consumption, and days with limited activity.

Sample size A total of 46 participants (23 per group) are required, accounting for a minimum clinically relevant difference of 1 mm in KTW gain, a standard deviation of 1.3 mm, 80% statistical power, 5% significance level, an intraclass correlation coefficient of 0.30 for multiple implants per patient, and a 15% dropout rate.

Statistical analysis The primary outcome will be analyzed in the intention-to-treat population using a generalized linear mixed model (GLMM), with patient as a random effect, adjusted for baseline KTW and study center.

研究类型

介入性

注册 (估计的)

46

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：Octavi Camps-Font, DDS MS PhD
  • 电话号码：+34 934 024 269
  • 邮箱：ocamps@ub.edu

研究联系人备份

学习地点

  • 西班牙
    • Barcelona
      • Barcelona、Barcelona、西班牙、08907
        • Hospital Odontològic Universitat de Barcelona, L'Hospitalet de Llobregat,
        • 接触：
          • Octavi Camps Font DDS MS PhD
          • 电话号码：+34 934 024 269
          • 邮箱：ocamps@ub.edu

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:

  • Men or women aged 18 years or older who voluntarily agree to sign the informed consent form before any study-related procedure is performed.
  • Single or multiple edentulous spaces (≤3 units) located in the posterior maxilla or mandible, presenting osseointegrated implants in first-stage surgery with a -healing period of more than 8 weeks.
  • ASA classification I or II.
  • Periodontal and peri-implant health.
  • O'Leary plaque index ≤15%.
  • Keratinized mucosa width ≤2 mm and/or vestibular depth <4 mm at at least one site.
  • Commitment to attend all follow-up visits over 6 months.

Exclusion Criteria:

  • Systemic diseases that may interfere with performing FGG (free gingival graft), including but not limited to: poorly controlled diabetes mellitus (HbA1c > 8% or per clinical judgment), immunodeficiencies or immunosuppressive treatment, uncontrolled hematological diseases or coagulation disorders, anticoagulant or antiplatelet treatment that cannot be adjusted according to standard clinical practice, active neoplasms under treatment, severe renal or hepatic insufficiency, decompensated cardiovascular diseases, and any other medical condition that, in the investigator's judgment, could compromise participant safety or proper tissue healing.
  • Any contraindication to oral surgical procedures.
  • Periodontal and peri-implant health as defined by the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions.
  • Patients who smoke tobacco or equivalent products, as well as former smokers with an abstinence period ≤12 months.
  • History of substance abuse (drugs or alcohol) or any other factor (e.g., severe psychiatric illness) that, in the investigator's opinion, could interfere with the patient's ability to cooperate and comply with the study.
  • Patients who have participated in a clinical trial within the last 30 days.
  • Pregnant or breastfeeding women.

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
有源比较器：Apical Flap Repositioning
Free gingival graft with apical repositioning and suturing of the vestibular mucosal flap to the periosteum during second-stage implant surgery.
程序：Free gingival graft with apical flap repositioning
Autologous free gingival graft harvested from the palate and placed at the recipient site. The vestibular mucosal flap is repositioned apically and sutured to the periosteum during second-stage implant surgery.
实验性的：Vestibular Mucosa Excision
Free gingival graft with excision of the vestibular mucous tissue during second-stage implant surgery.
程序：Free gingival graft with vestibular mucosa excision
Autologous free gingival graft harvested from the palate and placed at the recipient site. The vestibular mucous tissue is excised during second-stage implant surgery.

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
Peri-implant keratinized tissue width (KTW) gain
大体时间：Baseline (T0) to 6 months (T6m)
Absolute change in KTW, measured digitally as the linear distance between the mucosal margin and the mucogingival junction on the vestibular aspect of the implant, using Geomagic Control X® software on intraoral scan models (TRIOS 3®, 3Shape).
Baseline (T0) to 6 months (T6m)

次要结果测量

结果测量
措施说明
大体时间
Clinical gain in peri-implant keratinized tissue width (KTW)
大体时间：Baseline (T0) to 6 months (T6m)
Absolute change in KTW, measured clinically with a calibrated periodontal probe using a customized thermoplastic stent.
Baseline (T0) to 6 months (T6m)
Change in graft height
大体时间：Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft height, measured in millimeters (mm), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft width
大体时间：Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft width, measured in millimeters (mm), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Graft area contraction
大体时间：Immediate postoperative (Tim) to 6 months (T6m)
Percentage of graft area reduction between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Immediate postoperative (Tim) to 6 months (T6m)
Change in graft volume
大体时间：Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Change in graft volume, measured in cubic millimeters (mm³), between immediate postoperative and 6 months, assessed by 3D digital superimposition.
Immediate postoperative (Tim), 6 weeks (T6w), 3 months (T3m), 6 months (T6m)
Vestibular depth
大体时间：Baseline (T0) to 6 months (T6m)
Change in vestibular depth from baseline to 6 months, assessed both digitally and clinically.
Baseline (T0) to 6 months (T6m)
Surgical time
大体时间：Intraoperative (Tim)
Time in minutes from anesthesia administration to placement of the last suture.
Intraoperative (Tim)
Adverse events
大体时间：Immediate postoperative (Tim) to 6 months (T6m)
Incidence and nature of postoperative adverse events related to the free gingival graft procedure.
Immediate postoperative (Tim) to 6 months (T6m)
Clinician-perceived surgical difficulty
大体时间：Intraoperative (Tim)
Degree of surgical difficulty perceived by the clinician at the end of the procedure, evaluated using a 100 mm visual analogue scale (0 = no difficulty, 100 = maximum imaginable difficulty).
Intraoperative (Tim)
Postoperative pain
大体时间：Up to 7 days postoperat
Pain intensity recorded at the end of the procedure and at 2, 6, 12 and 24 hours, and daily for 7 days, using a 100 mm visual analogue scale (0 = no pain, 100 = worst imaginable pain).
Up to 7 days postoperat
Analgesic consumption
大体时间：Up to 7 days postoperative
Number of doses of ibuprofen 600 mg and paracetamol 1 g consumed during the first 7 postoperative days.
Up to 7 days postoperative
Patient global satisfaction
大体时间：7 days postoperative
Overall satisfaction with the intervention evaluated at 7 days postoperative using a 100 mm visual analogue scale (0 = completely dissatisfied, 100 = completely satisfied).
7 days postoperative
Days with limitation of daily activity
大体时间：Up to 7 days postoperative
Number of days with total or partial limitation of usual daily activity during the first 7 postoperative days.
Up to 7 days postoperative

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 Barcelona

合作者

Universidad Complutense de Madrid

调查人员

  • 研究主任：Octavi Camps Font、University of Barcelona

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。

有用的网址

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9月30日

初级完成 (估计的)

2028年9月30日

研究完成 (估计的)

2029年3月30日

研究注册日期

首次提交

2026年8月3日

首先提交符合 QC 标准的

2026年8月15日

首次发布 (实际的)

2026年8月19日

研究记录更新

最后更新发布 (实际的)

2026年8月19日

上次提交的符合 QC 标准的更新

2026年8月15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

其他研究编号

  • 26/2026

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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