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

NCT07551024 | Recruiting DMC

• 1 other identifier: FUE.REC(92)/11-2025
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrophic Edentulous Maxilla; Zygomatic Implants; Dental Implant; Guided Surgery; Accuracy of Dental Implant Placement

Keywords

Zygomatic implants; Severely atrophic maxilla; Surgical guides; Dental implant placement accuracy; Metal surgical guide; Resin surgical guide

Outcome Measures

Primary Outcomes (1)

• Implant placement accuracy

  Measured by deviation (mm, degrees) between planned and placed implant positions (CT superimposition) using computer software. on each side for assessment for accuracy of implant placement in each group

  from enrolment to the implant placement at 4 weeks

Secondary Outcomes (3)

• primary stability

  from time of enrolment to time of surgery 2 weeks

• Intraoperative Complications

  from enrolment to the time of surgery 2 weeks

• Surgical time

  measured intraoperatively during surgery

Study Arms (2)

Group B (Metallic nickel Guide)

ACTIVE COMPARATOR

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)

Group A (Resin Guide)

ACTIVE COMPARATOR

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

Interventions

Resin surgical Guide DEVICE

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.

Group A (Resin Guide)

Group B (Metallic nickel Guide) DEVICE

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.

Group B (Metallic nickel Guide)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Study Sites (1)

Future University in Egypt

New Cairo, Cairo Governorate, 11835, Egypt

RECRUITING

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• ramy ragab el beialy, proffessor

  cairo university in egypt

  STUDY CHAIR

• mohamed safwat eid, bachelor

  future unversity in egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed abozekry associate professor of oral and maxillofacial surgery at FUE, associate professor

CONTACT

00201012162020; Ahmed.Kamal@fue.edu.eg

aya magdy lecturer of oral and maxillofacial surgery at FUE, LECTURER

CONTACT

00201000252400; Aya.magdy@fue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Omar Magdy Mohamed Elsayed Elawady

Model Details: each patient will receive zygomatic implants on both sides of the upper jaw, using two different types of surgical guides split mouth. Group A - 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. Group B - Metallic Surgical Guide: The same CT scan and digital planning will be used. A metallic surgical guide (made of nickel using CAD/CAM technology) will be created. On the opposite side of the jaw, the zygomatic implant will be placed using this metallic guide. Both guides are used in the same surgery, one on each side of the upper jaw. This allows a direct comparison between the resin and metallic guides to see which one provides more accurate placement of the implants.

Study Record Dates

• First Submitted: April 20, 2026
• First Posted: April 24, 2026
• Study Start: November 3, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)