Evaluation of Accuracy of Three-Dimensionally Guided Zygomatic Implant Installation

NCT07463469 | Completed

• 1 other identifier: OS-3-23-13
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This study was conducted at the Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Tanta University. A prospective non-controlled clinical study was performed on ten patients with compromised zygomaticomaxillary bone. Surgical intervention was carried out using a customized surgical guide. Pre-surgical planning was performed using computed tomography (CT) scans for each patient. Surgical guides were fabricated using direct metal laser sintering technology. Zygomatic implants were inserted using a guided surgical protocol and specialized instruments. Postoperative CT scans were obtained to evaluate deviations between the planned and actual implant positions. Accuracy was assessed by superimposing the postoperative implant position onto the virtual pre-surgical implant plan using dedicated software. Descriptive and bivariate statistical analyses were performed.

Conditions

Maxillary Defect Reconstruction; Atrophic Edentulous Maxilla

Keywords

guided zygomatic implant surgery; Post-Mucormycosis Rehabilitation; Bone-Supported zygomatic implant guide

Outcome Measures

Primary Outcomes (6)

• implant success.

  Implant success was assessed based on clinical stability and osseointegration. Stability was evaluated using torque testing during implant uncovering with a torque value of 10-20 Ncm applied to the multiunit abutment screw without implant rotation.

  3 months

• Implant survival

  Implant survival was assessed based on the absence of implant mobility, pain, infection, peri-implant inflammation, suppuration, and progressive bone loss.

  1 year

• Coronal Deviation

  Deviation at the coronal entry point of the implant between the planned implant position and the actual postoperative implant position measured using three-dimensional superimposition of preoperative planning and postoperative CT scans.

  1 week

• Apical Deviation

  Linear deviation at the apical endpoint of the implant between the planned implant position and the postoperative implant position measured using three-dimensional image superimposition.

  1 week

• Angular Deviation

  Angular deviation between the long axis of the planned implant and the postoperative implant measured in degrees using 3D software analysis.

  1 week

• Soft tissue wound healing:

  Postoperative clinical evaluation of the surgical site including signs of inflammation, infection, or intraoral wound dehiscence.

  4 weeks

Secondary Outcomes (2)

• Prosthetic Survival

  1 year

• Oral Health Impact Profile (OHIP-14)

  1 year

Study Arms (1)

Single-arm interventional study

EXPERIMENTAL

Patients received zygomatic implants using a customized bone-supported surgical guide following three-dimensional preoperative planning.

Procedure: zygomatic implant installation using custamized bone supported surgical guide

Interventions

zygomatic implant installation using custamized bone supported surgical guide PROCEDURE

Zygomatic implant placement using a customized bone-supported surgical guide. Indications included: * Severe posterior maxillary bone deficiency preventing placement of conventional implants * Post-surgical maxillary defects with limited options for bone reconstruction due to inadequate soft tissue coverage * Failure of previous reconstructive procedures

Single-arm interventional study

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 1. Lack of maxillary posterior bone in which standard implants are impossible to insert.
• \. Post-surgical maxillary defects with limitations of maxillary bone reconstruction due to lack of soft tissue coverage.
• \. Failure of previous reconstructive procedures.

You may not qualify if:

• Opportunity of alternative treatment modalities with bone grafting and standard implants.
• Any relevant systemic or local diseases that might affect the bone healing, like uncontrolled diabetic patients or cancer patients who are still on chemotherapy or previously received radiation on the head and neck region.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

faculty of dentistry , Tanta university

Tanta, Elgharbia, 3111, Egypt

Location

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

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

Study Officials

• Eslam A Gharieb

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of oral and maxillofacial surgery department

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 11, 2026
• Study Start: June 20, 2023
• Primary Completion: November 15, 2024
• Study Completion: December 20, 2025
• Last Updated: March 11, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)