NCT06925438

"Computer-Guided vs Freehand Zygomatic Implant Placement

Comparison Between Computer Guided and Free Hand Placement of Zygomatic Implants (Clinical and Radiographic Evaluation)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Al-Azhar University · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

"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). Interventions Both Groups: Pre-op: CT scans for zygomatic bone assessment. Anesthesia: General anesthesia with local infiltration for hemostasis. Surgical Protocol: Full-thickness flap, implant placement , two-stage healing. Group B-Specific Steps: Digital implant path planning (entrance/exit points). Stereolithographic guide fabrication with metal sleeves. Guide fixation with monocortical screws during surgery. Rationale Zygomatic implants require high precision due to anatomical complexity. While free-hand placement depends on surgeon skill, computer guidance may reduce errors. This trial evaluates whether guided surgery improves accuracy (angular deviation) and reduces complications (sinusitis, infection). Methodological Rigor Randomization: Block randomization via SPSS. Blinding: Radiographic assessors blinded to group allocation. Sample Size: 16 implants (8/group), powered to detect 3.73° mean angular deviation difference (α=0.05, β=0.10; based on Grecchi et al. 2022). Ethical Compliance Approved by Al-Azhar University (Ref: 880/62). Consent forms documented risks/benefits (e.g., sinus perforation, infection).

Conditions

• Dental Implants
• Maxillary Diseases

Interventions

Type	Name	Description
PROCEDURE	Computer-guided zygomatic implant system	Preoperative digital planning (DICOM data) to fabricate guides with metal sleeves for drill alignment
PROCEDURE	free-hand zygomatic implant placement	Standard placement using sequential drills (2.8-3.6mm) under saline irrigation

Timeline

• Start date: 2023-01-10
• Primary completion: 2025-01-15
• Completion: 2025-03-12
• First posted: 2025-04-13
• Last updated: 2025-04-16

Locations

2 sites across 1 country: Egypt