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

NCT ID: NCT07124715

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2023-06-30

Brief 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.

Detailed 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.

Conditions

Atrophic Maxilla; Zygomatic Implants; Implant Surface

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Standard Rough Surface Zygomatic Implant

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.

Group Type: ACTIVE_COMPARATOR

Rough Surface Zygomatic Implant

Intervention Type: DEVICE

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

Modified Partially Machined Surface Zygomatic Implant

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.

Group Type: EXPERIMENTAL

Partially Machined Surface Zygomatic Implant

Intervention Type: DEVICE

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.

Interventions

Rough Surface Zygomatic Implant

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

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Bologna

OTHER

Sponsor Role: lead

Responsible Party

Pietro Felice

Principal Investigator, Head of Oral Surgery, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Hung K, Huang W, Wang F, Wu Y. Real-Time Surgical Navigation System for the Placement of Zygomatic Implants with Severe Bone Deficiency. Int J Oral Maxillofac Implants. 2016 Nov/Dec;31(6):1444-1449. doi: 10.11607/jomi.5526.

Reference Type: BACKGROUND

PMID: 27861671 (View on PubMed)

Branemark PI, Grondahl K, Ohrnell LO, Nilsson P, Petruson B, Svensson B, Engstrand P, Nannmark U. Zygoma fixture in the management of advanced atrophy of the maxilla: technique and long-term results. Scand J Plast Reconstr Surg Hand Surg. 2004;38(2):70-85. doi: 10.1080/02844310310023918.

Reference Type: BACKGROUND

PMID: 15202664 (View on PubMed)

Esposito M, Grusovin MG, Felice P, Karatzopoulos G, Worthington HV, Coulthard P. Interventions for replacing missing teeth: horizontal and vertical bone augmentation techniques for dental implant treatment. Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD003607. doi: 10.1002/14651858.CD003607.pub4.

Reference Type: BACKGROUND

PMID: 19821311 (View on PubMed)

Branemark PI, Hansson BO, Adell R, Breine U, Lindstrom J, Hallen O, Ohman A. Osseointegrated implants in the treatment of the edentulous jaw. Experience from a 10-year period. Scand J Plast Reconstr Surg Suppl. 1977;16:1-132. No abstract available.

Reference Type: BACKGROUND

PMID: 356184 (View on PubMed)

Other Identifiers

ZYGOMA01.17

Identifier Type: -

Identifier Source: org_study_id