Atrophic MaxillaNAVIZYG-SURFNCT07124715

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

A study testing Rough Surface Zygomatic Implant and Partially Machined Surface Zygomatic Implant in people with Atrophic Maxilla and Zygomatic Implants, run by University of Bologna.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrophic Maxilla, Zygomatic Implants, Implant Surface
What is being tested?: Rough Surface Zygomatic Implant and Partially Machined Surface Zygomatic Implant
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: No sites listed yet
Study dates: Jan 2017to Jun 2023
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 16Show fewer

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

About this study

Official title: Dynamic Navigation for Zygomatic Implant Rehabilitation: An Innovative Protocol Using an Intraoral Reference System and Evaluation of a New Zygomatic Implant Design

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.

Read the 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
Being tested: Rough Surface Zygomatic Implant, Partially Machined Surface Zygomatic Implant
Keywords: bone loss, zygomatic implants, implant surface, atrophic maxilla, oral rehabilitation, perimplantitis
Medical subject headings: Atrophic Maxilla, Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Rough Surface Zygomatic ImplantDevice
Surgical placement of a zygomatic implant with a fully roughened surface from apex to collar. Used for the control arm.
Partially Machined Surface Zygomatic ImplantDevice
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.

Study groups in NCT07124715
Study group	Role	What they receive
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. Receives: 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. Receives: Device: Partially Machined Surface Zygomatic Implant

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 5 years after implant placement

Secondary outcomes (5)

Surgical Site Preparation Time
Time required to prepare each zygomatic implant site will be recorded, from the start of the first drill to the complete insertion of the implant. The comparison aims to detect differences between the rough and partially machined implant groups.
Measured: Intraoperative (during implant placement)
Radiographic Evaluation of Peri-Implant Bone
Assessment of peri-implant bone levels will be performed through standardized radiographs (OPT and teleradiography) and analyzed using calibrated software. Bone changes will be compared between implant types.
Measured: At prosthesis delivery, and at 1, 3, and 5 years post-loading
Peri-implant Probing Depth (PD)
Mean probing depth, in millimetres, measured circumferentially around each implant to assess peri-implant soft-tissue health. Results will be reported as mean ± SD per implant.
Measured: 1, 3, and 5 years after functional loading
Number of Implants with Bleeding on Probing (BOP)
Count of dental implants that exhibit bleeding upon gentle circumferential probing (≤ 0.25 N). The result will be reported as the total number of affected implants and the corresponding percentage of all implants examined at each follow-up visit.
Measured: 1, 3, and 5 years after functional loading
Number of Implants with Suppuration
Count of dental implants showing the presence of suppuration (pus discharge) upon gentle probing (≤ 0.25 N) during clinical examination. The result will be reported as the number and percentage of affected implants at each follow-up visit.
Measured: 1, 3, and 5 years after functional loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2017Jun 2023

First posted15 Aug 2025
Study startJan 2017
Primary completionFeb 2018
Study completionJun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Atrophic MaxillaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07124715
Sponsor's protocol ID: ZYGOMA01.17
Acronym: NAVIZYG-SURF
Status last verified: Jul 2025
First submitted: 31 Jul 2025
Last updated: 15 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 27861671
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.
PubMed 15202664
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.
PubMed 19821311
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.
PubMed 356184

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Atrophic Maxilla trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dynamic Navigation for Zygomatic Implant Rehabilitation: An Innovative Protocol Using an Intraoral Reference System and Evaluation of a New Zygomatic Implant Design
ClinicalTrials.gov ID: NCT07124715
Acronym / sponsor ID: NAVIZYG-SURF / ZYGOMA01.17
Conditions: Atrophic Maxilla, Zygomatic Implants, Implant Surface
Keywords: bone loss, zygomatic implants, implant surface, atrophic maxilla, oral rehabilitation, perimplantitis
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: University of BolognaUniversity, hospital or other
Study start: Jan 2017 (actual)
Primary completion: Feb 2018 (actual)
Study completion: Jun 2023 (actual)
First posted: 15 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Standard Rough Surface Zygomatic Implant	Active comparator	Device: Rough Surface Zygomatic ImplantPatients 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.
Modified Partially Machined Surface Zygomatic Implant	Experimental	Device: Partially Machined Surface Zygomatic ImplantPatients 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rough Surface Zygomatic ImplantSurgical placement of a zygomatic implant with a fully roughened surface from apex to collar. Used for the control arm.	Device	Standard Rough Surface Zygomatic Implant
Partially Machined Surface Zygomatic ImplantSurgical 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.	Device	Modified Partially Machined Surface Zygomatic Implant

Primary outcome

Implant Success Rate of Zygomatic Fixtures
Time frame: 5 years after implant placement
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 secondary outcomes

Surgical Site Preparation Time
Time frame: Intraoperative (during implant placement)
Radiographic Evaluation of Peri-Implant Bone
Time frame: At prosthesis delivery, and at 1, 3, and 5 years post-loading
Peri-implant Probing Depth (PD)
Time frame: 1, 3, and 5 years after functional loading
Number of Implants with Bleeding on Probing (BOP)
Time frame: 1, 3, and 5 years after functional loading
Number of Implants with Suppuration
Time frame: 1, 3, and 5 years after functional loading

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
Background: PubMed 27861671Hung 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.
Background: PubMed 15202664Branemark 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.
Background: PubMed 19821311Esposito 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.
Background: PubMed 356184Branemark 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.
Individual participant dataSharing planned: No

Related trials for Atrophic Maxilla

Recruiting
Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
Alveolar Bone Loss, Sinus Floor Augmentation
Recruiting
The Application of a Biphasic Calcium Sulfate Graft Material in Sinus Floor Elevation
Alveolar Bone Loss, Edentulism Nos
Recruiting
Two-Stage Transcrestal Sinus Lift With Osseodensification: Allograft vs Autogenous-Xenograft
Severely Atrophic Posterior Maxilla
Recruiting
Alveolar Ridge Preservation (ARP) in the Posterior Maxilla After the Extraction of Maxillary Molars
Alveolar Bone Loss
RecruitingPhase 2/3
Assessment of a New Enhanced Xenograft in Open Maxillary Sinus Augmentation
Maxillary Sinus Floor Augmentation, Maxillary Sinus Elevation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A study testing Rough Surface Zygomatic Implant and Partially Machined Surface Zygomatic Implant in people with Atrophic Maxilla and Zygomatic Implants, run by University of Bologna.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Implant Success Rate of Zygomatic Fixtures (time frame: 5 years after implant placement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07124715, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.