Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh
2026年7月7日 更新者:Hams Hamed Abdelrahman
Assessment of Three-Dimensional Bone Augmentation of Severely Atrophied Posterior Mandibular Alveolar Ridges Using Customized-3D Zirconia Barriers Versus Pre-bent Titanium Mesh: A Randomized Controlled Clinical Trial
Zirconia can be considered as an alternative and innovative material suitable for GBR because it has high biocompatibility, together with a scarce tissue integration.
Zirconia barriers could be a predictable and alternative barrier material for GBR in terms of (i) biocompatibility, (ii) ease of use and removal, (iii) exposure management, (iv) bone regeneration outcomes.
研究概览
研究类型
介入性
注册 (估计的)
16
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Moataz Nasr
- 电话号码:01000353417
- 邮箱:Mo3taznasr@gmail.com
学习地点
-
-
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Kafr Elsheikh、埃及
- 招聘中
- Kafr El-sheikh University
-
接触:
- Moataz Nasar, BDS
- 电话号码:002 01000353417
- 邮箱:mo3taznasr@gmail.com
-
首席研究员:
- Moataz Nasr, BDS
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients are systemically medically free according to the American Society of Anesthesiologists (ASA) considered as ASA I.
- Ability to maintain good oral hygiene as evidenced in recall visits.
- patients who had a partial or completely edentulous alveolar ridge with apparent 3D defect following teeth loss.
- All patients were free from any local or general disease that may interfere with bone healing and had no history of previous grafting procedure at the designated edentulous ridge.
- The ridge had to exhibit severe vertical and horizontal (3D) alveolar ridge deficiency with alveolar ridge height less than 7 mm from the alveolar crest to the inferior alveolar canal and width less than 5 mm which was firstly measured by CBCT, or a clinically apparent increase in inter-arch space relative to the adjacent natural teeth.
- Pre-operative clinical assessment of soft tissue coverage was done to cover the graft and its membrane, in addition to assessment of occlusion and inter-arch distance should allow for the graft, membrane, implan and the future prosthesis.
Exclusion Criteria:
- Smoker (> 25 cigarettes/ day).
- Patients undergoing radiotherapy or chemotherapy
- Patients having infection or local lesions in the area of surgery.
- Patients with diabetes mellitus or bone diseases which may compromise the results.
- Patient with poor oral hygiene or active periodontal disease.
- Patient with limited mouth opening.
- Participation in other clinical trials
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:氧化锆
|
It includes eight patients seeking for placement of customized Zirconia barrier after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.
|
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实验性的:Titanium
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It includes eight patients seeking for placement prebent titanium mesh as barriers after GBR in 1st stage surgery then implants placement in 2nd stage surgery in the alveolar ridges.
|
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 |
|---|---|---|
|
change in vertical height of ridge
大体时间:up to 6 months
|
Cone Beam Computed Tomography (CBCT) was done immediately (1 week) and after six months to evaluate the changes in vertical, horizontal and volumetric measurements of the ridge.
OnDemand3D™ software was used to evaluate vertical and horizontal height.
Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
|
up to 6 months
|
|
change in horizontal width of ridge
大体时间:up to 6 months
|
Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used.
Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
|
up to 6 months
|
|
change in volume of ridge
大体时间:up to 6 months
|
Cone Beam Computed Tomography (CBCT) will be done immediately (1 week) and after six months OnDemand3D™ software will be used.
Measurements were taken as follows: From the toolbar, the ruler was selected from the measurement section.
|
up to 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
symptoms of infection
大体时间:up to one month
|
Any symptoms of infection including swelling, redness, hotness, pus discharge, and pain will be recorded
|
up to one month
|
|
manifestations of wound healing disturbance
大体时间:up to one month
|
observation for any manifestations of wound healing disturbance, as wound dehiscence and hardware exposure will be recorded
|
up to one month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年8月3日
初级完成 (估计的)
2026年9月1日
研究完成 (估计的)
2026年9月1日
研究注册日期
首次提交
2026年7月7日
首先提交符合 QC 标准的
2026年7月7日
首次发布 (实际的)
2026年7月13日
研究记录更新
最后更新发布 (实际的)
2026年7月13日
上次提交的符合 QC 标准的更新
2026年7月7日
最后验证
2026年7月1日
更多信息
与本研究相关的术语
其他研究编号
- KFSIRB200-205
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.