"Computer-Guided vs Freehand Zygomatic Implant Placement

NCT06925438 | Completed

• 1 other identifier: ZygomaticRCT880/62
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Dental Implants; Maxillary Diseases

Keywords

"Zygomatic implants"; "Atrophic maxilla rehabilitation"; "Guided implant surgery"; "Free-hand dental implantation"; "3D-printed surgical guides"

Outcome Measures

Primary Outcomes (3)

• Angular deviation of zygomatic implants

  Difference in degrees between planned (virtual) and actual post-operative implant position, measured at the apical point using superimposed CT scans

  Measured immediately post-operatively (Day 0)

• Apical linear deviation of zygomatic implants

  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)

  Measured immediately post-operatively (Day 0)

• Coronal linear deviation of zygomatic implants

  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)

  Measured immediately post-operatively (Day 0)

Secondary Outcomes (2)

• 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

Study Arms (2)

Computer-Guided Zygomatic Implants

ACTIVE COMPARATOR

Zygomatic implants placed using 3D-printed bone-supported surgical guides created from preoperative CT scans.

Procedure: Computer-guided zygomatic implant system

Free-Hand Zygomatic Implants

PLACEBO COMPARATOR

Zygomatic implants placed using anatomical landmarks (ZAGA classification) without surgical guides.

Procedure: free-hand zygomatic implant placement

Interventions

Computer-guided zygomatic implant system PROCEDURE

Preoperative digital planning (DICOM data) to fabricate guides with metal sleeves for drill alignment

Computer-Guided Zygomatic Implants

free-hand zygomatic implant placement PROCEDURE

Standard placement using sequential drills (2.8-3.6mm) under saline irrigation

Free-Hand Zygomatic Implants

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥40 years
• Atrophic maxillary ridge (Cawood \& Howell Class IV-VI)
• Maxillary defects due to trauma, tumor resection, or congenital conditions

You may not qualify if:

• Acute maxillary sinusitis
• Uncontrolled systemic diseases affecting osseointegration
• Pathological lesions in maxilla/zygoma
• Heavy smoking (\>20 cigarettes/day)

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (2)

Faculty of Dental Medicine - Boys, Al-Azhar University

Cairo, Cairo Governorate, 11651, Egypt

Location

Oral and Maxillofacial Surgery Department, Faculty of Dental Medicine - Boys, Al-Azhar University

Cairo, Cairo Governorate, 11651, Egypt

Location

MeSH Terms

Conditions

Maxillary Diseases

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases

Study Officials

• Bahaa El-Din Abd Raboo, phd

  Al-Azhar University, faculty of dentistry ,Oral & Maxillofacial Surgery Dept

  STUDY DIRECTOR

• Mohamed Abdel Akhar, PhD

  Al-Azhar University, faculty of dentistry, Oral & Maxillofacial Surgery Dept

  STUDY DIRECTOR

• Abdelfattah Moawad, BDS, MSc

  Al-Azhar University, faculty of dentistry, Oral & Maxillofacial Surgery Dept

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: "The participants, care providers, and outcomes assessors were blinded to the method of implant placement (computer-guided or freehand) to minimize bias."
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Study Record Dates

• First Submitted: April 6, 2025
• First Posted: April 13, 2025
• Study Start: January 10, 2023
• Primary Completion: January 15, 2025
• Study Completion: March 12, 2025
• Last Updated: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)