Assessment of Bone Density Following Application of Bone Marrow Aspirate Concentrate Around Zygomatic Implants (Via the Intrasinus Approach): A Case Series Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
This prospective case series is designed to evaluate the effect of autologous bone marrow aspirate concentrate applied around zygomatic implants placed via the intrasinus approach. The study will include adult patients with severe maxillary atrophy requiring zygomatic implant rehabilitation. BMAC will be prepared from iliac crest aspirate and loaded on gelatin sponge at the implant site. Peri-implant bone density will be assessed using CBCT at baseline and 6 months postoperatively. Secondary implant stability will be measured using resonance frequency analysis. (Recruitment has not started yet)
详细描述
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.)
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
盲法说明
No masking is used. Both the surgeon and participant are aware of the intervention.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
zygomatic implant group
All eligible participants with atrophied maxilla receiving zygomatic implant placement for fixed prosthetic rehabilitation.
干预措施: zygomatic implants placement (Procedure)
研究者
Tilal Sidahmed Mohamed Ahmed
Resident in oral and maxillofacial surgery department
Cairo University