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

NCT07124715 | Completed

• 1 other identifier: ZYGOMA01.17
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Atrophic Maxilla; Zygomatic Implants; Implant Surface

Keywords

bone loss; zygomatic implants; implant surface; atrophic maxilla; oral rehabilitation; perimplantitis

Outcome Measures

Primary Outcomes (1)

• Implant Success Rate of Zygomatic Fixtures

  The success of each zygomatic implant will be assessed clinically by evaluating the absence of pain, absence of mobility or rotation under contra-torque testing, and the presence of healthy peri-implant tissues. Clinical evaluation will be supported by radiographic analysis to confirm peri-implant bone maintenance and the absence of pathological signs.

  5 years after implant placement

Secondary Outcomes (5)

• Surgical Site Preparation Time

  Intraoperative (during implant placement)

• Radiographic Evaluation of Peri-Implant Bone

  At prosthesis delivery, and at 1, 3, and 5 years post-loading

• Peri-implant Probing Depth (PD)

  1, 3, and 5 years after functional loading

• Number of Implants with Bleeding on Probing (BOP)

  1, 3, and 5 years after functional loading

• Number of Implants with Suppuration

  1, 3, and 5 years after functional loading

Study Arms (2)

Standard Rough Surface Zygomatic Implant

ACTIVE COMPARATOR

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.

Device: Rough Surface Zygomatic Implant

Modified Partially Machined Surface Zygomatic Implant

EXPERIMENTAL

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.

Device: Partially Machined Surface Zygomatic Implant

Interventions

Rough Surface Zygomatic Implant DEVICE

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

Standard Rough Surface Zygomatic Implant

Partially Machined Surface Zygomatic Implant 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.

Modified Partially Machined Surface Zygomatic Implant

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bologna: lead

Related Publications (4)

• 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.

  PMID: 27861671 BACKGROUND

• 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.

  PMID: 15202664 BACKGROUND

• 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.

  PMID: 19821311 BACKGROUND

• 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.

  PMID: 356184 BACKGROUND

MeSH Terms

Conditions

Atrophic Maxilla; Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Oral Surgery, Clinical Professor

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 15, 2025
• Study Start: January 1, 2017
• Primary Completion: February 1, 2018
• Study Completion: June 1, 2023
• Last Updated: August 15, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share