使用聚甲基丙烯酸甲酯 (PMMA) 膜引导骨再生 (GBR) 评估骨再生
使用定制 3D 打印聚甲基丙烯酸甲酯 (PMMA) 膜在水平缺陷上颌美容区进行引导骨再生 (GBR) 后骨再生的评估
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.
研究概览
地位
地位
干预/治疗
干预/治疗
详细说明
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.
In addition, it has a relatively low cost when it is compared to other types of membranes used in guided bone regeneration (GBR).
研究类型
研究类型
注册 (实际的)
注册
阶段
阶段
- 不适用
联系人和位置
学习地点
-
-
Cairo Governorate
-
Cairo、Cairo Governorate、埃及、11553
- Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Cairo University
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参与标准
资格标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
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)
手臂数量
武器和干预
参与者组/臂参与者组/臂 |
干预/治疗干预/治疗 |
|---|---|
|
其他: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. |
guided bone regeneration (GBR) using polymethylmethacrylate (PMMA) polymer as membrane.
其他名称:
|
研究衡量的是什么?
主要结果指标
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
amount of bone gain
大体时间:6 months postoperative
|
radiographic using cone beam computed tomography (CBCT) |
6 months postoperative
|
次要结果测量
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
quality of bone regenerated
大体时间:6 months after surgical procedure
|
bone core biopsy (histomorphometric analysis): Because the augmentation wasn't maintained in most cases, the resulting specimens varied too much to support a standardized quantitative histomorphometric protocol. Consequently, descriptive histopathology was performed instead. |
6 months after surgical procedure
|
其他结果措施
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
post operative ridge width
大体时间:6 months postoperative
|
using bone caliper |
6 months postoperative
|
|
initial implant stability
大体时间:6 months post operative
|
using manual ratchet |
6 months post operative
|
合作者和调查者
调查人员
调查人员
- 研究主任:Hesham El Hawary、Professor of Oral and Maxillofacial surgery, Cairo university
出版物和有用的链接
一般刊物
- Elgali I, Omar O, Dahlin C, Thomsen P. Guided bone regeneration: materials and biological mechanisms revisited. Eur J Oral Sci. 2017 Oct;125(5):315-337. doi: 10.1111/eos.12364. Epub 2017 Aug 19.
- Freitas de Andrade P, Meza-Mauricio J, Kern R, Faveri M. Labial Repositioning Using Print Manufactured Polymethylmethacrylate- (PMMA-) Based Cement for Gummy Smile. Case Rep Dent. 2021 Dec 21;2021:7607522. doi: 10.1155/2021/7607522. eCollection 2021.
- Khojasteh A, Kheiri L, Motamedian SR, Khoshkam V. Guided Bone Regeneration for the Reconstruction of Alveolar Bone Defects. Ann Maxillofac Surg. 2017 Jul-Dec;7(2):263-277. doi: 10.4103/ams.ams_76_17.
- Benic GI, Hammerle CH. Horizontal bone augmentation by means of guided bone regeneration. Periodontol 2000. 2014 Oct;66(1):13-40. doi: 10.1111/prd.12039.
- Lee SW, Kim SG. Membranes for the Guided Bone Regeneration. Maxillofac Plast Reconstr Surg. 2014 Nov;36(6):239-46. doi: 10.14402/jkamprs.2014.36.6.239. Epub 2014 Nov 12.
- Fernandes da Silva AL, Borba AM, Simao NR, Pedro FL, Borges AH, Miloro M. Customized polymethyl methacrylate implants for the reconstruction of craniofacial osseous defects. Case Rep Surg. 2014;2014:358569. doi: 10.1155/2014/358569. Epub 2014 Jun 30.
- AlSubaie MF, Al-Sharydah AM, Nassim HM, Alhawsawi A. Orbital Floor Blowout Fracture Reconstruction Using Moldable Polymethyl Methacrylate: A Report of Two Cases and Their Imaging Findings. Open Access Emerg Med. 2022 May 25;14:223-232. doi: 10.2147/OAEM.S359173. eCollection 2022.
研究记录日期
研究主要日期
学习开始 (实际的)
学习开始
初级完成 (实际的)
初级完成
研究完成 (实际的)
研究完成
研究注册日期
首次提交
首次提交
首先提交符合 QC 标准的
首先提交符合 QC 标准的
首次发布 (实际的)
首次发布
研究记录更新
最后更新发布 (实际的)
最后更新发布
上次提交的符合 QC 标准的更新
上次提交的符合 QC 标准的更新
最后验证
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
其他研究编号
- OMFS 3310
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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