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Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla (GBR-PRGF-Maxil)

2026年9月3日 更新者:Universidade do Porto

Guided Bone Regeneration Combined With Plasma Rich in Growth Factors for Vertical and Horizontal Augmentation of the Atrophic Edentulous Maxilla: A Prospective Clinical Case Series With One-Year Follow-up

This prospective interventional clinical study evaluated guided bone regeneration combined with plasma rich in growth factors for vertical and horizontal augmentation of the atrophic edentulous maxilla.

Participants with severe maxillary ridge atrophy requiring bone augmentation before implant-supported rehabilitation underwent guided bone regeneration using a composite graft of autogenous bone and anorganic bovine bone mineral combined with plasma rich in growth factors. Barrier membranes were stabilised with titanium pins, and lateral-window sinus floor elevation was performed when indicated. Implants were placed using a delayed protocol at re-entry after 6-9 months.

Radiographic bone height and width were assessed by cone-beam computed tomography before surgery, immediately after surgery, at 6-9 months, and at 12 months. The study also recorded graft dimensional stability, implant placement, and surgical or postoperative complications.

研究概览

详细说明

Severe atrophy of the edentulous maxilla may limit fixed implant-supported rehabilitation because of insufficient residual alveolar ridge height and width. Guided bone regeneration is used to reconstruct deficient ridges before implant placement, while plasma rich in growth factors may provide an autologous fibrin matrix enriched with platelet-derived mediators.

This prospective clinical study assessed a guided bone regeneration protocol combined with plasma rich in growth factors for reconstruction of the atrophic edentulous maxilla. Eligible participants presented with an edentulous atrophic maxilla requiring vertical and/or horizontal ridge augmentation before implant placement. The surgical protocol included guided bone regeneration using a composite graft of autogenous bone and anorganic bovine bone mineral in a 60:40 ratio, combined with plasma rich in growth factors prepared from autologous blood. The grafted area was covered with a barrier membrane stabilised with titanium pins. Titanium-reinforced PTFE membranes were used for defects requiring vertical space maintenance, while collagen membranes were used for horizontal augmentations. Lateral-window sinus floor elevation was performed simultaneously when indicated by posterior maxillary anatomy.

Cone-beam computed tomography was obtained pre-surgically, immediately post-operatively, at 6-9 months, and at 12 months. Linear vertical and horizontal bone measurements were performed at three standardised maxillary reference sites: the lateral wall of the nasal cavity, the medial wall of the maxillary sinus, and the zygomatic apophysis. Bone gain was calculated in millimetres and as percentage change relative to the pre-surgical dimension. Graft resorption was calculated between the immediate post-operative and 12-month assessments. Implant placement and intraoperative or postoperative complications were also recorded.

研究类型

介入性

注册 (实际的)

11

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

      • Porto、葡萄牙
        • Faculty of Dental Medicine, university of Porto

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 18 years or older
  • Fully edentulous maxilla requiring implant-supported fixed oral rehabilitation
  • Atrophic maxillary alveolar ridge requiring vertical and/or horizontal bone augmentation before implant placement
  • Residual alveolar ridge width below 6 mm and/or residual bone height below 10 mm, as assessed by cone-beam computed tomography
  • ASA physical status I or II
  • Clinical indication for guided bone regeneration, with or without simultaneous maxillary sinus floor elevation
  • Adequate oral hygiene and willingness to comply with postoperative instructions and follow-up visits
  • Written informed consent provided.

Exclusion Criteria:

  • ASA physical status III or higher
  • Uncontrolled systemic disease contraindicating oral surgery or bone regenerative procedures
  • Uncontrolled diabetes mellitus or other systemic condition expected to impair wound healing or bone regeneration
  • History of radiotherapy to the head and neck region
  • Current or previous intravenous antiresorptive or antiangiogenic therapy associated with risk of medication-related osteonecrosis of the jaw
  • Active oral infection at the surgical site
  • Untreated periodontal disease or poor oral hygiene incompatible with regenerative surgery
  • Heavy smoking or unwillingness to comply with perioperative smoking restrictions
  • Pregnancy or breastfeeding
  • Inability to understand the study procedures or provide informed consent
  • Inability or unwillingness to attend scheduled follow-up visits
  • Any medical, anatomical, or behavioural condition judged by the investigator to interfere with surgery, healing, follow-up, or interpretation of outcomes

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:GBR Combined With PRGF
Participants with an atrophic edentulous maxilla requiring vertical and/or horizontal bone augmentation before implant-supported rehabilitation underwent guided bone regeneration combined with plasma rich in growth factors. The procedure used a composite graft of autogenous bone and anorganic bovine bone mineral combined with PRGF. Barrier membranes were stabilised with titanium pins, and simultaneous lateral-window sinus floor elevation was performed when clinically indicated.
Guided bone regeneration was performed for reconstruction of the atrophic edentulous maxilla. Autogenous bone harvested intra-orally was combined with anorganic bovine bone mineral in a 60:40 ratio and mixed with autologous plasma rich in growth factors. The grafted area was covered with a barrier membrane stabilised with titanium pins. Titanium-reinforced PTFE membranes were used for defects requiring vertical space maintenance, while collagen membranes were used for horizontal augmentations. Lateral-window sinus floor elevation was performed simultaneously when indicated. Implants were placed using a delayed protocol at re-entry after 6-9 months.
其他名称:
  • GBR + PRGF
  • Plasma Rich in Growth Factors
  • Vertical Ridge Augmentation
  • Horizontal Ridge Augmentation
  • Alveolar Ridge Augmentation
  • Sinus Floor Elevation

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 Vertical and Horizontal Maxillary Bone Dimensions
大体时间:Pre-surgery, immediately post-operative, 6-9 months, and 12 months
Vertical and horizontal bone dimensions were measured using standardized cone-beam computed tomography at three maxillary reference sites: the lateral wall of the nasal cavity, the medial wall of the maxillary sinus, and the zygomatic apophysis. Bone gain was calculated in millimeters and as percentage change relative to the pre-surgical dimension.
Pre-surgery, immediately post-operative, 6-9 months, and 12 months

次要结果测量

结果测量
措施说明
大体时间
Graft Resorption
大体时间:Immediately post-operative to 12 months
Graft resorption was calculated as the percentage change in vertical and horizontal bone dimensions between the immediate post-operative CBCT and the 12-month CBCT assessment.
Immediately post-operative to 12 months
Number of Dental Implants Placed
大体时间:6-9 months after augmentation
Number of dental implants placed during delayed implant placement at re-entry following guided bone regeneration.
6-9 months after augmentation
Incidence of Surgical and Postoperative Complications
大体时间:From augmentation surgery to 12 months
Intraoperative and postoperative complications were recorded, including infection, graft loss, membrane-related complications, and other adverse events. Complications were classified according to severity and whether they affected graft integrity.
From augmentation surgery to 12 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。

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)

2023年3月1日

初级完成 (实际的)

2025年11月30日

研究完成 (实际的)

2025年12月31日

研究注册日期

首次提交

2026年6月12日

首先提交符合 QC 标准的

2026年6月12日

首次发布 (实际的)

2026年6月17日

研究记录更新

最后更新发布 (实际的)

2026年9月9日

上次提交的符合 QC 标准的更新

2026年9月3日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

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 publicly shared because of the small sample size, the single-centre nature of the study, and the potential risk of participant re-identification from clinical, radiographic, and surgical data.

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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