Custom-Made Polyether Ether Ketone Membrane Versus Polytetrafluoroethylene Membrane in Maxillary Alveolar Ridge Augmentation: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Volumetric Bone Gain
研究概览
简要总结
This randomized controlled clinical study aims to evaluate and compare the effectiveness of custom-made polyether ether ketone (PEEK) membranes versus polytetrafluoroethylene (PTFE) membranes in guided bone regeneration for maxillary alveolar ridge augmentation in the esthetic zone. Thirty patients requiring ridge augmentation prior to dental implant placement will be enrolled and randomly allocated into two equal groups. Group A will receive customized PEEK membranes, while Group B will be treated with PTFE membranes. Clinical and radiographic assessments, including cone beam computed tomography (CBCT), will be performed immediately postoperatively, at 6 months, and at 12 months to evaluate volumetric, horizontal, and vertical bone gain as well as soft tissue healing and complication rates.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
The study is assessor-blinded. Clinical and surgical personnel are aware of treatment allocation due to the nature of the intervention. Radiographic outcomes (CBCT measurements of volumetric, horizontal, and vertical bone gain) will be evaluated by an independent assessor blinded to group allocation.
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Volumetric Bone Gain
时间窗: 6 months after surgery
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.
次要结局
未报告次要终点