Comparison Between Computer Guided and Free Hand Placement of Zygomatic Implants (Clinical and Radiographic Evaluation)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 4
- 主要终点
- Angular deviation of zygomatic implants
研究概览
简要总结
This randomized trial compares computer-guided versus free-hand zygomatic implant placement in patients with atrophic maxillae or maxillary defects. Participants receive either 3D-navigated implants (using stereolithographic guides) or conventional free-hand placement. Primary outcomes measure accuracy through apical angular deviation (°), apical/coronal linear deviations (mm) relative to MSP/FHP/CP planes (CT-based), while secondary outcomes assess implant stability (ISQ) and complications (sinusitis/infection) over 6 months. The study evaluates whether guided surgery improves precision in complex maxillary rehabilitation.
详细描述
"This study was retrospectively registered due to initial lack of awareness of prospective registration requirements. All procedures followed ethical guidelines (Approval #880/62), and results are reported transparently."
Study Design
A single-center, randomized controlled trial conducted at Al-Azhar University, comparing computer-guided versus free-hand zygomatic implant placement. Participants are allocated 1:1 to:
Group A (Free-hand): Implants placed using ZAGA classification with conventional surgical techniques.
Group B (Guided): Implants placed via 3D-printed bone-supported surgical templates (DICOM-based planning).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
"The participants, care providers, and outcomes assessors were blinded to the method of implant placement (computer-guided or freehand) to minimize bias."
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥40 years
- •Atrophic maxillary ridge (Cawood & Howell Class IV-VI)
- •Maxillary defects due to trauma, tumor resection, or congenital conditions
排除标准
- •Acute maxillary sinusitis
- •Uncontrolled systemic diseases affecting osseointegration
- •Pathological lesions in maxilla/zygoma
- •Heavy smoking (>20 cigarettes/day)
结局指标
主要结局
Angular deviation of zygomatic implants
时间窗: Measured immediately post-operatively (Day 0)
Difference in degrees between planned (virtual) and actual post-operative implant position, measured at the apical point using superimposed CT scans
Apical linear deviation of zygomatic implants
时间窗: Measured immediately post-operatively (Day 0)
Difference in millimeters between planned (virtual) and actual post-operative implant position at the apical point, measured using superimposed CT scans along three planes midsagittal plane (MSP) - Frankfort horizontal plane (FHP) - coronal plane (CP)
Coronal linear deviation of zygomatic implants
时间窗: Measured immediately post-operatively (Day 0)
Difference in millimeters between planned and actual implant position at the coronal point (implant neck), measured using superimposed CT scans along three planes midsagittal plane (MSP) - Frankfort horizontal plane (FHP) - coronal plane (CP)
次要结局
- Implant stability quotient (ISQ)(Immediately post-op and at 6 months)
- Postoperative complication rates(Assessed at 1 week, 1 month, 3 months, and 6 months post-op)
研究者
Abdelfattah Moawad Abdelfattah
Assistant Lecturer
Al-Azhar University