Evaluation Of Bone Regenerated After Guided Bone Regenration (GBR) Using Customized 3D Printed Polymethylmethacrylate (PMMA) Membrane in Horizontally Deficient Maxillary Aesthetic Zone
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- amount of bone gain
研究概览
简要总结
To evaluate the quantity and quality of bone generated, radiographically and histomorphometrically, after guided bone regeneration (GBR) using a membrane of 3D printed custom made (PMMA) and subsequent stability of delayed implant placement.
详细描述
Guided bone regeneration (GBR), is the most widely used technique to facilitate bone generation. It depends on using a biocompatible membrane that acts as physical barrier preventing the connective tissue from invading the bone defect.
To achieve maximum bone regeneration, GBR membrane should have several characteristics, including:
- Biocompatibility.
- Proper stiffness for space maintenance.
- Prevent epithelial cell migration.
- Appropriate resorption time after proper bone regeneration. Membranes used in guided bone regeneration (GBR) may have some limitations as the need of second surgery for removal of the membrane (in case of non-resorbable membranes as titanium mesh or expanded polytetrafluoroethylene (e-PTFE) membranes), lake of space maintenance (as collagen membranes) in addition to their high cost.
Thus, we aim to use a commercially available material as polymethyl methacrylate (PMMA) with (GBR) to facilitate bone generation as well as subsequent implant placement.
Recent forms of (PMMA), have been certified to be biocompatible and safe for skin and mucosal contact. PMMA is characterized by having high toughness which may provide a space maintenance when using as membrane in guided bone regeneration (GBR). The PMMA prosthesis can be pre-fabricated, which results in reduction of surgical time, easy technical handling and good esthetic results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with edentulous area related to horizontally deficient aesthetic zone of maxilla.
- •Patients are physically healthy with no medical history of any systemic or local disease that would contraindicate ridge augmentation and/or implant surgery or complicate the healing process. (Severe liver or kidney disease, a history of head and neck radiotherapy, chemotherapy at the time of surgery, uncontrolled diabetes, active periodontal in the residual dentition, inflammatory or autoimmune disorders of the oral mucosa, poor oral hygiene, patient failure to cooperate, and any other disease condition contraindicating the oral surgery).
- •Non-smokers.
- •Free from temporomandibular joint disorders and abnormal oral habits such as bruxism.
- •The edentulous ridges were covered with optimal thickness of keratinized mucosa with no signs of inflammation, ulceration or scar tissue.
- •The occlusion shows sufficient inter-arch space for future prothesis.
排除标准
- •General contraindications to surgery.
- •Patients subjected to irradiation in the head and neck area less than 1 year before fixation.
- •Untreated periodontitis.
- •Poor oral hygiene.
- •Uncontrolled diabetes.
- •Pregnant or nursing.
- •Substance abuse.
- •Psychiatric problems or unrealistic expectations.
- •Severe bruxism or clenching.
- •Immunosuppressed or immunocompromised.
- •Treated or under treatment with intravenous amino-bisphosphonates.
- •Patients participating in other studies, if the present protocol could not be properly followed
研究组 & 干预措施
patient with horizontally deficient ridge in ethetic maxilary zone need (GBR) and implant placement
a group of patients with with horizontally deficient ridge in esthetic maxillary zone will undergo ridge augmentation with guided bone regeneration (GBR) technique using polymethylmethacrylate (PMMA) polymer as membrane.
干预措施: guided bone regeneration (GBR). (Procedure)
结局指标
主要结局
amount of bone gain
时间窗: 6 months postoperative
radiographic using cone beam computed tomography (CBCT)
次要结局
- quality of bone regenerated(6 months after surgical procedure)
研究者
Rana Mohamed Sherif Abdel Mawgood
Evaluation Of Bone Regenerated After Guided Bone Regenration (GBR) using customized 3D printed Polymethylmethacrylate (PMMA) membrane in horizontally deficient maxillary aesthetic zone.
Cairo University