Assessment of Bone Density Following Application of BMAC Around Zygomatic Implant (BMAC)
Assessment of Bone Density Following Application of Bone Marrow Aspirate Concentrate Around Zygomatic Implants (Via the Intrasinus Approach): A Case Series Study
研究概览
详细说明
Zygomatic implants provide a viable option for rehabilitation of the severely atrophic maxilla. However, achieving optimal osseointegration remains a challenge due to poor bone quality in the posterior maxilla. Bone marrow aspirate concentrate contains mesenchymal stem cells and growth factors that may enhance local bone formation.
Knowledge Gap:
BMAC has been investigated with conventional dental implants, but its use with zygomatic implants placed via the intrasinus approach is limited to isolated case reports. A systematic evaluation of its effect on peri-implant bone density and stability in this specific context is lacking. This case series addresses that gap.
Study Design and Setting:
This is a single-center, prospective case series planned at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University. The primary hypothesis is that BMAC application will improve bone density and secondary stability of zygomatic implants at 6 months. (Recruitment has not commenced.)
Surgical Procedure:
Under general anaesthesia, approximately 30 ml of bone marrow will be aspirated from the anterior iliac crest. The aspirate will be processed using a double centrifugation protocol to obtain the buffy coat layer, which will then be loaded onto a gelatine sponge. Zygomatic implants will be placed through a lateral sinus window using the intrasinus trajectory. The BMAC-loaded sponge will be applied around the implant prior to closure. Conventional implants will be placed in the anterior maxilla to support the planned full-arch prosthesis.
Follow-up Protocol:
Patients will be reviewed weekly during the first month, then monthly for 6 months. Cone beam computed tomography will be performed immediately postoperatively and at 6 months to assess changes in bone density in Hounsfield Units. Resonance frequency analysis will be performed at 6 months to evaluate secondary implant stability. Adverse events will be recorded throughout the follow-up period.
Ethical Considerations:
The study protocol has been submitted to the Ethics Committee of Scientific Research, Faculty of Dentistry, Cairo University and is currently pending approval. A written informed consent will be obtained from all participants in Arabic prior to enrollment. Patient data will be coded and stored in a secure, password-protected database accessible only to the research team. The study is self-funded with no conflicts of interest declared.
Outcomes:
The primary outcome is the change in peri-implant bone density at 6 months. Secondary outcome includes secondary stability of the implants . Data will be summarized descriptively given the case series design.
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:Tilal Sidahmed Ahmed, BDS
- 电话号码:00201555225441
- 邮箱:Tilal.sidahmed@dentistry.cu.edu.eg
研究联系人备份
- 姓名:Walaa Kadry Hafez, Associate professor of OMFS
- 电话号码:00201061527359
- 邮箱:walaakadry@dentistry.cu.edu.eg
学习地点
-
-
Cairo Governate
-
Cairo、Cairo Governate、埃及、11562
- Faculty of Dentistry, Cairo University , Department of Oral and Maxillofacial Surgery
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients over 18 years old.
- Patients requiring rehabilitation with zygomatic implants in the posterior maxilla.
- Patients who are willing to participate and able to provide informed consent.
Exclusion Criteria:
- Pregnant women.
- Individuals with history of radiation therapy or other contraindications for surgery.
- Patients with bone marrow diseases.
- Patients with local infections at intraoral surgical site or bone marrow aspiration site.
- Patients unwilling to sign the written informed consent.
- Heavy smokers >20 cigarettes per day.
- Patients taking contraindicated drugs such as bisphosphonates.
- Patients with sinus pathology or acute sinusitis.
- Patients with malignancy or pathology of maxilla.
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)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:zygomatic implant group
All eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation.
|
placement of zygomatic implants via the intrasinus approach in the posterior maxilla of patients with severely atrophied maxilla.
Bone marrow aspirate concentrate prepared by double centrifugation of bone marrow aspirated from anterior iliac crest of the patient then loaded on gelatine sponge and applied around the zygomatic implants.
Conventional implants may be placed in the anterior maxilla.
Procedure performed under general anaesthesia with propofol induction and sevoflurane maintenance.
|
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 |
|---|---|---|
|
Bone density around zygomatic implants
大体时间:6 months postoperatively
|
Bone density measured using Cone Beam Computed Tomography (CBCT) and expressed in Hounsfield Units (HU)
|
6 months postoperatively
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
secondary stability of zygomatic implants
大体时间:6 months postoperatively
|
Implant stability measured using Resonance Frequency Analysis (RFA) device (Osstell) and expressed as Implant Stability Quotient (ISQ)
|
6 months postoperatively
|
合作者和调查者
调查人员
- 首席研究员:Ramy Ragab Elbeialy, Professor of OMFS、Cairo University
研究记录日期
研究主要日期
学习开始 (估计的)
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
- omfs3-3-20-
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
Individual participant data will not be shared due to ethical restrictions and patient privacy regulations.
IPD will be shared after publication.
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
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.