NobelZygoma TiUltra Implant System Study

NCT07258940 | Not Yet Recruiting

• 1 other identifier: T-197
• Study Type: interventional
• Target: 85
• Locations: 2 countries
• Sites: 2

Brief Summary

The goal of this prospective study is to assess short term (12-months) clinical outcomes of NobelZygoma TiUltra implants and Multi-unit Abutment Xeal in the rehabilitation of participants with severely atrophic maxilla treated with zygomatic dental implant procedure. The main goal is to assess the sinusitis occurrence at 12-months after implant insertion. Other objectives are to assess: soft tissue health; biological and technical complication; patient's experience, outcomes (sinonasal symptoms and oral health-related quality of life) and satisfaction; clinician's experience with handling of device and satisfaction; implant, abutment and prosthetic survival and adverse events. Participants will be asked to complete questionnaires at pretreatment visit, postoperative visit, and after 6-months and 12-months of implant insertion. At 12-months a radiological exam (CBCT) will be asked for the participant for the evaluation of the radiological condition of the maxillary sinus.

Conditions

Edentulous Maxilla; Maxillary Bone Loss; Atrophic Maxilla

Keywords

"zygomatic implants"; "zygoma implants"

Outcome Measures

Primary Outcomes (1)

• Maxillary sinusitis at 12-months post-implant placement

  The diagnosis of maxillary sinusitis is based on the following criteria: A positive clinical diagnosis is made when all of the following criteria from SNOT-22 are met simultaneously: 1. The participant reports at least two clinical symptoms, one of which must be either: nasal blockage/obstruction/congestion, or nasal discharge (anterior or posterior nasal drip). Additional symptoms may include: facial pain or pressure, reduction or loss of smell. 2. There is a clinically significant worsening in symptoms, demonstrated by a ≥12-point increase in the total SNOT-22 score from baseline (pre-treatment). 3. If the participant exhibits partial symptoms or if the diagnosis remains uncertain, the Principal Investigator (PI) will refer the participant to an ENT specialist for further evaluation.

  At 12-months follow-up of zygomatic implant insertion

Secondary Outcomes (13)

• PREMs

  At pre-treatment; and after 10 days, 6- and 12-months of zygomatic implant placement

• Pain assessment

  10 days after zygomatic implant placement

• Patient satisfaction

  10 days, 6-months and 12-months after zygomatic implant placement

• OHIP-21

  At pre-treatment and after 10 days, 6-months and 12-months of zygomatic implant placement

• Keratinized mucosa status

  At 6-months and 12-months follow-up of zygomatic implant placement

Other Outcomes (1)

• Prosthetic survival

  From placement until 12-months follow-up

Study Arms (1)

NobelZygoma TiUltra implant system in the rehabilitation of severely atrophic maxillae

OTHER

Participant will receive zygomatic implant treatment for the rehabilitation of severely atrophic maxilla. The treatment will be performed as per standard-of-care and participant's anatomic conditions. The NobelZygoma TiUltra implant and Multi-unit Abutment Xeal Zygoma will be used in all study participants.

Device: NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant; Device: Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 17° Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 45° Multi.Unit Abutment Xeal Zygoma CC RP; 60° Multi-Unit Abutment Xeal Zygoma CC RP

Interventions

NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant DEVICE

All participants will receive NobelZygoma TiUltra implant and Multi-unit Abutment Xeal as part of the implant/prosthetic zygomatic rehabilitation procedure. Implants and abutments will be selected as per surgeon preference and participant's need. Radiological exam will be performed at pre-treatment and 12-months follow-up. Patients will be followed-up after placement of implant at 10-days, 6-months and 12-months follow-up. At 12-months a standardized clinical and radiological criteria (using the SNOT-22 and Lund-Mackay respectively) will be used to describe and quantify the occurrence of maxillary sinusitis across all study centers for the sinusitis diagnose.

NobelZygoma TiUltra implant system in the rehabilitation of severely atrophic maxillae

Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 17° Multi-Unit Abutment Xeal Zygoma Ext Hex RP; 45° Multi.Unit Abutment Xeal Zygoma CC RP; 60° Multi-Unit Abutment Xeal Zygoma CC RP DEVICE

All participants will receive NobelZygoma TiUltra implant and Multi-unit Abutment Xeal as part of the implant/prosthetic zygomatic rehabilitation procedure. Implants and abutments will be selected as per surgeon preference and participant's need. Radiological exam will be performed at pre-treatment and 12-months follow-up. Patients will be followed-up after placement of implant at 10-days, 6-months and 12-months follow-up. At 12-months a standardized clinical and radiological criteria (using the SNOT-22 and Lund-Mackay respectively) will be used to describe and quantify the occurrence of maxillary sinusitis across all study centers for the sinusitis diagnose

NobelZygoma TiUltra implant system in the rehabilitation of severely atrophic maxillae

Eligibility Criteria

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

You may qualify if:

• Participant has signed the informed consent form (ICF).
• Participant aged ≥ 18 years at the time of treatment.
• Medical and anatomical conditions are in accordance with the applicable IFU.
• Participant with a severely atrophic maxilla classified as Cawood and Howell class V or VI
• Suitable for immediate loading.

You may not qualify if:

• Presence of acute or chronic maxillary sinusitis.
• Zygomatic bone pathologies including tumors, infections, or congenital abnormalities
• History of recurrent sinusitis (≥ 4 occurrences/year)
• Pre-operative LM score of ≥ 1
• Uncontrolled systemic disorders including poorly controlled hypertension, uncontrolled diabetes, cardiovascular disease.
• Active malignancy or currently undergoing oncological treatment.
• History of severe maxillary jaw injury or maxillofacial trauma.
• Moderate and heavy smokers (defined as \> 5 cigarettes a day).
• Severe bruxism or dysfunctional tendencies
• Previous oro-maxillofacial radiotherapy.
• Use of bisphosphonates.
• Pregnant or lactating women
• Implant loaded \> 1 week of zygomatic implant placement

Sponsors & Collaborators

• Nobel Biocare: lead

Study Sites (2)

Universitiy of Verona, Unit of Stomatology and Maxillo-Facial Surgery

Verona, 37134, Italy

Location

Hirslanden Medical Center

Aarau, 5000, Switzerland

Location

Related Publications (5)

• Yalcin M, Can S, Akbas M, Dergin G, Garip H, Aydil BA, Varol A. Retrospective Analysis of Zygomatic Implants for Maxillary Prosthetic Rehabilitation. Int J Oral Maxillofac Implants. 2020 Jul/Aug;35(4):750-756. doi: 10.11607/jomi.8196.

  PMID: 32724927 BACKGROUND

• Hirsch JM, Ohrnell LO, Henry PJ, Andreasson L, Branemark PI, Chiapasco M, Gynther G, Finne K, Higuchi KW, Isaksson S, Kahnberg KE, Malevez C, Neukam FW, Sevetz E, Urgell JP, Widmark G, Bolind P. A clinical evaluation of the Zygoma fixture: one year of follow-up at 16 clinics. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):22-9. doi: 10.1016/j.joms.2004.06.030.

  PMID: 15332178 BACKGROUND

• Davo R, Bankauskas S, Laurincikas R, Kocyigit ID, Mate Sanchez de Val JE. Clinical Performance of Zygomatic Implants-Retrospective Multicenter Study. J Clin Med. 2020 Feb 9;9(2):480. doi: 10.3390/jcm9020480.

  PMID: 32050501 BACKGROUND

• Borgonovo A, Grandi T, Vassallo S, Signorini L. Extrasinus Zygomatic Implants for the Immediate Rehabilitation of the Atrophic Maxilla: 1-Year Postloading Results From a Multicenter Prospective Cohort Study. J Oral Maxillofac Surg. 2021 Feb;79(2):356-365. doi: 10.1016/j.joms.2020.10.003. Epub 2020 Oct 13.

  PMID: 33160924 BACKGROUND

• Aparicio C, Polido WD, Chow J, Davo R, Al-Nawas B. Round and flat zygomatic implants: effectiveness after a 1-year follow-up non-interventional study. Int J Implant Dent. 2022 Apr 1;8(1):13. doi: 10.1186/s40729-022-00412-8.

  PMID: 35359196 BACKGROUND

MeSH Terms

Conditions

Atrophic Maxilla

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Maxillary Diseases; Jaw Diseases; Stomatognathic Diseases

Study Officials

• Ewa Bednarek

  Nobel Biocare

  STUDY DIRECTOR

Central Study Contacts

Claudia D Fagundes

CONTACT

+41795407703; claudia.diasazevedof@envistaco.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, interventional, multicenter, single cohort study

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: December 2, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); CH (1)