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Dynamic Navigation for Zygomatic Implant Rehabilitation Using an Intraoral Reference System: Evaluation of a New Zygomatic Implant Design

NCT07124715 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-08-15

No results posted yet for this study

Summary

This clinical study aims to evaluate the effectiveness and safety of zygomatic implants placed using dynamic navigation technology. Specifically, it compares two types of zygomatic implants with different surface characteristics: one with a fully rough surface and another with a partially smooth (machined) surface near the gum line. The goal is to determine whether surface design affects surgical performance, healing, implant success, and patient outcomes. A total of 22 patients with severe upper jaw bone loss will receive both types of implants-one on each side of the upper jaw-in a randomized, split-mouth design. The study also evaluates pain, swelling, healing time, and patient quality of life over a 5-year follow-up period.

Conditions

  • Atrophic Maxilla
  • Zygomatic Implants
  • Implant Surface

Interventions

DEVICE

Rough Surface Zygomatic Implant

Surgical placement of a zygomatic implant with a fully roughened surface from apex to collar. Used for the control arm.

DEVICE

Partially Machined Surface Zygomatic Implant

Surgical placement of a modified zygomatic implant with a smooth machined coronal portion, a non-threaded machined middle section, and a rough apical portion. Used for the test arm.

Sponsors & Collaborators

  • University of Bologna

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-02-28
Completion
2023-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07124715 on ClinicalTrials.gov