Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Static Surgical Guides in Severely Atrophic Maxilla (guided surgery)

May 4, 2026 updated by: Omar Elawady, Future University in Egypt

Evaluation of Zygomatic Implant Placement Accuracy Using Fully Metallic vs Resin-based Surgical Guides in Severely Atrophic Maxilla.

Some patients lose a large amount of bone in the upper jaw. When this happens, it can be difficult to place regular dental implants. In these cases, special implants called zygomatic implants can be used. These implants are longer than normal implants and are fixed in the cheekbone, which usually has enough bone to support them. They can help support fixed teeth for patients with severe bone loss in the upper jaw.

Placing zygomatic implants requires careful planning and high accuracy. To help guide the surgeon during the operation, a surgical guide can be used. A surgical guide is a custom-made device that helps the surgeon place the implant in the planned position.

Surgical guides can be made from different materials. The most common type is made from resin (a strong plastic material) using 3D printing. Recently, fully metallic surgical guides have been developed. These metal guides may be stronger and more stable during surgery, but it is not yet clear if they improve the accuracy of implant placement.

The purpose of this study is to compare the accuracy of metal surgical guides and resin surgical guides when placing zygomatic implants in patients with severe bone loss in the upper jaw.

Patients included in the study will undergo a clinical examination and a CT scan before surgery to plan the implant positions. During the surgery, each patient will receive zygomatic implants on both sides of the upper jaw. On one side, the implants will be placed using a metal surgical guide, and on the other side, they will be placed using a resin surgical guide. This allows the two types of guides to be compared in the same patient.

After the surgery, another CT scan will be taken to check the final position of the implants. The planned implant position will be compared with the actual position after surgery to measure the accuracy of placement.

The results of this study will help determine whether metallic surgical guides or resin surgical guides provide better accuracy when placing zygomatic implants.

Participation in this study is voluntary. All patients will receive full information about the study and will sign a consent form before participating.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: ahmed abozekry associate professor of oral and maxillofacial surgery at FUE, associate professor
  • Phone Number: 00201012162020 00201012162020
  • Email: Ahmed.Kamal@fue.edu.eg

Study Contact Backup

  • Name: aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER
  • Phone Number: 00201000252400
  • Email: Aya.magdy@fue.edu.eg

Study Locations

  • Egypt
    • Cairo Governorate
      • New Cairo, Cairo Governorate, Egypt, 11835
        • Recruiting
        • Future University in Egypt
        • Contact:
          • lobna abdelaziz head of department of oral and maxillofacial surgery at FUE, professor
          • Phone Number: 00201099925769
          • Email: laziz@fue.edu.eg
        • Principal Investigator:
          • omar magdy elawady, Bachelor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥18 years with severely atrophic maxilla.
  • Acquired maxillary defects resulting from trauma, pathology, or previous surgical resection.
  • Indicated for zygomatic implant-supported fixed prosthesis.
  • Sufficient mouth opening for zygomatic implants placement.
  • Patients willing to sign informed consent and attend follow-ups.

Exclusion Criteria:

  • Uncontrolled systemic disease affecting healing (e.g., uncontrolled diabetes, etc).
  • Heavy smokers
  • Previous radiotherapy or bisphosphonate therapy.
  • Active sinus or nasal infection.
  • Severe parafunctional habits (e.g., bruxism).
  • Pregnant or lactating women.
  • Patients with psychiatric disorders affecting compliance.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group B (Metallic nickel Guide)

CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created.

, the zygomatic implant will be placed using this metallic guide on one side.
Device: Group B (Metallic nickel Guide)
CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. , the zygomatic implant will be placed using this metallic guide on one side.
Active Comparator: Group A (Resin Guide)
CT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement. On the assigned side, the zygomatic implant will be placed using this resin guide
Device: Resin surgical Guide

Before surgery, a CT scan and a digital impression of the mouth will be taken. A resin surgical guide (made with biocompatible 3D-printed material) will be created to guide the implant placement.

On the assigned side, the zygomatic implant will be placed using this resin guide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant placement accuracy
Time Frame: from enrolment to the implant placement at 4 weeks
Measured by deviation (mm, degrees) between planned and placed implant positions (CT superimposition) using computer software Using Real Guide. on each side for assessment for accuracy of implant placement in each group
from enrolment to the implant placement at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Complications
Time Frame: from enrolment to the time of surgery 2 weeks

This outcome assesses any adverse events or procedural difficulties occurring during zygomatic implant placement. Examples include:

Excessive bleeding beyond normal surgical expectations Damage to adjacent anatomical structures (e.g., infraorbital nerve, orbital floor ) Fracture or deformation of the surgical guide during the procedure Difficulties in achieving planned implant trajectory or insertion Any other unanticipated events affecting the safety or conduct of the surgery All intraoperative complications will be documented by the operating surgeon in real time
from enrolment to the time of surgery 2 weeks
primary stability
Time Frame: from time of enrolment to time of surgery 2 weeks
the primary stability is assessed after implant placement at time of surgery using osstell in ISQ
from time of enrolment to time of surgery 2 weeks
Surgical time
Time Frame: measured intraoperatively during surgery in minutes
This outcome measures the duration of the zygomatic implant placement procedure. Surgical time is defined as the time from the initial incision to the completion of implant placement and suture closure Time will be recorded in minutes using a standard surgical timer This outcome helps determine whether the type of surgical guide affects the operative workflow and efficiency
measured intraoperatively during surgery in minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Future University in Egypt

Investigators

  • Study Chair: ramy ragab el beialy, proffessor, cairo university in egypt
  • Principal Investigator: mohamed safwat eid, bachelor, future unversity in egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

April 20, 2026

First Submitted That Met QC Criteria

April 20, 2026

First Posted (Actual)

April 24, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUE.REC(92)/11-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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