Custom-Made PEEK Versus PTFE Membranes in Maxillary Alveolar Ridge Augmentation
Custom-Made Polyether Ether Ketone Membrane Versus Polytetrafluoroethylene Membrane in Maxillary Alveolar Ridge Augmentation: A Randomized Controlled Clinical Trial
研究概览
详细说明
Guided bone regeneration (GBR) is a widely accepted technique used to reconstruct deficient alveolar ridges prior to or in conjunction with dental implant placement. This study is designed to evaluate the clinical and radiographic outcomes of two different non-resorbable barrier membranes in maxillary ridge augmentation: customized polyether ether ketone (PEEK) membranes and polytetrafluoroethylene (PTFE) membranes.
Thirty patients requiring maxillary alveolar ridge augmentation in the esthetic zone will be recruited from the Outpatient Clinic of the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University. Patients will be randomly allocated into two groups of equal size. Group A will receive patient-specific 3D-printed PEEK membranes designed using cone beam computed tomography (CBCT) data and computer-aided design/computer-aided manufacturing (CAD/CAM) technology. Group B will receive PTFE membranes stabilized over the grafted site using bone tacks.
In both groups, autogenous bone graft combined with xenogeneic bone substitute will be used for ridge augmentation. Standard surgical protocols will be followed, including flap elevation, recipient site preparation, graft placement, and tension-free primary closure.
Clinical outcomes will be assessed by evaluating soft tissue healing, infection, membrane exposure, and wound dehiscence. Radiographic outcomes will be evaluated using CBCT scans taken immediately postoperatively, at 6 months, and at 12 months. Three-dimensional analysis will be performed using specialized software to measure volumetric bone gain as well as linear horizontal and vertical ridge augmentation.
The study aims to determine whether customized PEEK membranes provide comparable or superior outcomes to PTFE membranes in terms of bone regeneration, stability of augmented volume, and postoperative complications.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Dania Raad, BDS
- 电话号码:00201063498933
- 邮箱:raaddania7@gmail.com
学习地点
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Dakhaliya
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Al Mansurah、Dakhaliya、埃及、12345
- 招聘中
- Dania Raad
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接触:
- Dania Raad, BDS
- 电话号码:00201063498933
- 邮箱:raaddania7@gmail.com
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-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
Age between 20 and 45 years. Male or female participants. Presence of single or multiple missing teeth associated with vertical alveolar defects (vertical bone height less than 8 mm), horizontal alveolar defects (ridge width less than 6 mm), or combined defects in the maxillary esthetic zone requiring alveolar ridge augmentation before implant placement.
Good oral hygiene.
Exclusion Criteria:
Uncontrolled medical disorders contraindicating surgical intervention. Systemic diseases or medications affecting bone metabolism. Current or previous bisphosphonate therapy. History of radiotherapy. History of chemotherapy. Smokers.
学习计划
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 |
|---|---|
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实验性的:PEEK Membrane Group
Participants undergo maxillary alveolar ridge augmentation using a customized perforated polyether ether ketone (PEEK) membrane in combination with particulate bone graft material prior to implant placement.
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Customized perforated polyether ether ketone (PEEK) membrane designed from preoperative CBCT data and used for guided bone regeneration during maxillary alveolar ridge augmentation.
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实验性的:PTFE Membrane Group
Participants undergo maxillary alveolar ridge augmentation using a polytetrafluoroethylene (PTFE) membrane in combination with particulate bone graft material prior to implant placement.
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Polytetrafluoroethylene (PTFE) membrane used for guided bone regeneration during maxillary alveolar ridge augmentation.
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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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Volumetric Bone Gain
大体时间:6 months after surgery
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Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans. Volumetric bone gain in the augmented maxillary alveolar ridge measured using cone beam computed tomography (CBCT) and three-dimensional reconstruction software. Volumetric analysis will be performed by comparing immediate postoperative and 6-month postoperative CBCT scans. |
6 months after surgery
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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 (估计的)
研究完成 (估计的)
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
其他研究编号
- MS.26.01.108
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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