Guided Bone Regeneration Combined With PRGF for Atrophic Edentulous Maxilla (GBR-PRGF-Maxil)
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
地位
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Porto、葡萄牙
- Faculty of Dental Medicine, university of Porto
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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 |
|---|---|
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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.
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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:
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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 |
|---|---|---|
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Change in Vertical and Horizontal Maxillary Bone Dimensions
大体时间:Pre-surgery, immediately post-operative, 6-9 months, and 12 months
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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.
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Pre-surgery, immediately post-operative, 6-9 months, and 12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Graft Resorption
大体时间:Immediately post-operative to 12 months
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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.
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Immediately post-operative to 12 months
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Number of Dental Implants Placed
大体时间:6-9 months after augmentation
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Number of dental implants placed during delayed implant placement at re-entry following guided bone regeneration.
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6-9 months after augmentation
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Incidence of Surgical and Postoperative Complications
大体时间:From augmentation surgery to 12 months
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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.
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From augmentation surgery to 12 months
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 5/2022 FMDUP-PRGF
- 5/2022 (其他标识符:Ethics Committee for Health of the Faculty of Dental Medicine, U. Porto)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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