Dynamic Navigation for Zygomatic Implant Rehabilitation Using an Intraoral Reference System: Evaluation of a New Zygomatic Implant Design (NAVIZYG-SURF)

University of Bologna

Status: Completed

Conditions: Atrophic Maxilla; Implant Surface; Zygomatic Implants

Treatments: Device: Rough Surface Zygomatic Implant; Device: Partially Machined Surface Zygomatic Implant

Study type: Interventional

Funder types: Other

Identifiers

NCT07124715

ZYGOMA01.17

Details and patient eligibility

About

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.

Full description

This prospective, randomized, split-mouth clinical study investigates the use of dynamic navigation for the placement of zygomatic implants in patients with severely atrophic maxillae. The primary aim is to compare two different surface configurations of zygomatic implants: a fully rough surface versus a partially machined (smooth) coronal surface. Each of the 22 enrolled patients will receive both implant types-one per side-allowing for direct intra-patient comparison.

All surgeries are planned using three-dimensional imaging and performed with a dynamic navigation system (ImplaNav), calibrated for the longer drills required for zygomatic implant sites. The study evaluates surgical accuracy, implant stability, preparation time, postoperative pain and swelling, sinus membrane response, and long-term implant and prosthetic success. Patient quality of life is also monitored over a 5-year follow-up using standardized questionnaires and radiographic assessments.

This study aims to provide evidence on whether implant surface design influences clinical performance and healing outcomes in zygomatic implant rehabilitation.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients requiring partial or full rehabilitation of the atrophic maxilla

Candidates for placement of at least one zygomatic implant per side (right and left), connected to at least one standard or zygomatic implant

Severe maxillary atrophy confirmed by CT scan, with insufficient bone for conventional implants or only sufficient bone for 2 frontal implants (minimum diameter 3.5 mm, length 8 mm)

Residual alveolar crest height ≤ 4 mm beneath the maxillary sinus

Age ≥ 18 years

Signed informed consent

Exclusion criteria

General contraindications to oral surgery

History of radiation therapy to the head and neck exceeding 70 Gy

Compromised or suppressed immune system

Current or past use of intravenous bisphosphonates

Uncontrolled diabetes mellitus

Alcohol or drug dependency

Psychiatric disorders

Pregnancy or breastfeeding

Participation in other clinical trials

Inability to attend a 5-year follow-up

Limited mouth opening (< 3.5 cm interincisal distance)

Absence of opposing dentition or lower prosthesis

Acute or chronic infection in the intended implant site

Untreated active periodontal disease

Poor oral hygiene motivation

Radiographic signs of sinus membrane inflammation or ostium obstruction

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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22 participants in 2 patient groups

Standard Rough Surface Zygomatic Implant

Active Comparator group

Description:

Patients receive a zygomatic implant with a fully roughened surface (from apex to collar) on one side of the maxilla. Implant placement is performed using dynamic navigation. This arm serves as the control in a split-mouth randomized design.

Treatment:

Device: Rough Surface Zygomatic Implant

Modified Partially Machined Surface Zygomatic Implant

Experimental group

Description:

Patients receive a zygomatic implant with a modified surface, including a smooth machined coronal portion, a non-threaded machined intermediate section, and a rough apical portion, on the contralateral side of the maxilla. Implant placement is performed using dynamic navigation. This arm represents the test condition in the split-mouth design.

Treatment:

Device: Partially Machined Surface Zygomatic Implant