"Computer-Guided vs Freehand Zygomatic Implant Placement
NCT ID: NCT06925438
Last Updated: 2025-04-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2023-01-10
2025-03-12
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Computer-Guided Zygomatic Implants
Zygomatic implants placed using 3D-printed bone-supported surgical guides created from preoperative CT scans.
Computer-guided zygomatic implant system
Preoperative digital planning (DICOM data) to fabricate guides with metal sleeves for drill alignment
Free-Hand Zygomatic Implants
Zygomatic implants placed using anatomical landmarks (ZAGA classification) without surgical guides.
free-hand zygomatic implant placement
Standard placement using sequential drills (2.8-3.6mm) under saline irrigation
Interventions
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Computer-guided zygomatic implant system
Preoperative digital planning (DICOM data) to fabricate guides with metal sleeves for drill alignment
free-hand zygomatic implant placement
Standard placement using sequential drills (2.8-3.6mm) under saline irrigation
Eligibility Criteria
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Inclusion Criteria
* Atrophic maxillary ridge (Cawood \& Howell Class IV-VI)
* Maxillary defects due to trauma, tumor resection, or congenital conditions
Exclusion Criteria
* Uncontrolled systemic diseases affecting osseointegration
* Pathological lesions in maxilla/zygoma
* Heavy smoking (\>20 cigarettes/day)
40 Years
ALL
No
Sponsors
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Al-Azhar University
OTHER
Responsible Party
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Abdelfattah Moawad Abdelfattah
Assistant Lecturer
Principal Investigators
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Bahaa El-Din Abd Raboo, phd
Role: STUDY_DIRECTOR
Al-Azhar University, faculty of dentistry ,Oral & Maxillofacial Surgery Dept
Mohamed Abdel Akhar, PhD
Role: STUDY_DIRECTOR
Al-Azhar University, faculty of dentistry, Oral & Maxillofacial Surgery Dept
Abdelfattah Moawad, BDS, MSc
Role: PRINCIPAL_INVESTIGATOR
Al-Azhar University, faculty of dentistry, Oral & Maxillofacial Surgery Dept
Locations
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Faculty of Dental Medicine - Boys, Al-Azhar University
Cairo, Cairo Governorate, Egypt
Oral and Maxillofacial Surgery Department, Faculty of Dental Medicine - Boys, Al-Azhar University
Cairo, Cairo Governorate, Egypt
Countries
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Other Identifiers
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ZygomaticRCT880/62
Identifier Type: -
Identifier Source: org_study_id
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