NobelZygoma TiUltra Implant System Study

This is a prospective, interventional, multicenter study that is planned to include 9 sites and 85 participants with severely atrophic maxilla (characterized by class V-VI according to the Cawood and Howell's classification). Participants will be consecutively enrolled upon providing informed consent and meeting all of the inclusion and none of the exclusion criteria (details in eligibility section). Zygomatic implant procedure will be performed as per clinician standard of care and participant's anatomy. Both hybrid and quad zygoma techniques, as well as any implant trajectory can be used in the study (e.g. intra-sinus; extra-sinus; sinus slot). Enrolled participants will be treated with NobelZygoma TiUltra implants and respective abutments in accordance with the IFU. All zygomatic implants will be immediately loaded.

The study is designed to describe and quantify the occurrence of maxillary sinusitis in participants treated with NobelZygoma TiUltra implants and Multi-unit Abutments Xeal Zygoma.

The working assumption is that the incidence of sinusitis can be reliably measured at 12 months using standardized clinical (SNOT-22) and radiological (Lund-Mackay) criteria in participants rehabilitated with this treatment approach The primary endpoint of this clinical investigation is the specificity of diagnosis of maxillary sinusitis at 12-months post-implant placement using a combination of clinical and radiological evaluation, using SNOT-22 questionnaire and LM (Lund-Mackay) scoring system for the clinical and CBCT analysis respectively. Other endpoint and parameters will be described in Outcome measures section.

All included participants will be followed for 12-months post-implant placement to assess the safety, performance, and clinical benefits of TiUltra-surfaced zygomatic implants and Mulit-unit Abutment Xeal Zygoma. Possible dropouts and withdrawals, as well as possible adverse events, will be monitored during the entire investigation period.

Each participant will be assigned a participant ID to maintain the confidentiality of the collected data, which will be recorded in the dedicated eCRF. The eCRF system meets EU GDPR requirements for safe data handling. The data will be processed by the eCRF provider for storage purposes and further processed and analyzed by the sponsor.

• 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.
• 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

Primary outcomes

• Maxillary sinusitis at 12-months post-implant placement [At 12-months follow-up of zygomatic implant insertion]: 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.

Secondary outcomes

• PREMs [At pre-treatment; and after 10 days, 6- and 12-months of zygomatic implant placement]: Evaluate patient reported experience measures (PREMs) from pre-treatment to 12-month follow-up using Likert scale
• Pain assessment [10 days after zygomatic implant placement]: Assess patient reported pain at postoperative visit using VAS scale (from 0 (no pain) to 100 (worst pain possible)
• Patient satisfaction [10 days, 6-months and 12-months after zygomatic implant placement]: Assess patient satisfaction with function and esthetics using VAS scale (from 0 - not satisfied to 100 fully satisfied
• OHIP-21 [At pre-treatment and after 10 days, 6-months and 12-months of zygomatic implant placement]: Evaluate oral health-related quality of life using OHIP-21 questionnaire from pre-treatment to 12-month follow-up.
• Keratinized mucosa status [At 6-months and 12-months follow-up of zygomatic implant placement]: Keratinized mucosa status will be evaluated per zygomatic implant, without the prosthesis in place, and using the following score: 0 =No keratinized mucosa around the implant 1. =Mucosa surrounding the implant is partially keratinized 2. = The entire mucosa surrounding the implant is keratinized
• Modified Bleeding Index (mBI) [At 6- and 12-months follow-up of zygomatic implant placement]: The mBI will be evaluated at zygomatic implant level, without the prosthesis in place, using the following score system: 0=No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant 1. Isolated bleeding spots visible. 2. Blood forms a confluent red line on the margin. 3. Heavy or profuse bleeding.
• Biological [From implant placement until12-months after implant placement]: Biological complications will be recorded
• Adverse Events [From implant placement until 12-months after implant placement]: All adverse events (AEs), serious adverse events (SAEs), adverse device effects (ADEs), serious adverse device effects (SADEs), device deficiencies (DDs), and unanticipated serious adverse device effects (USADEs) will be recorded from implant placement to the 12-month follow-up.
• Implant survival rate [From time of placement to 12-months follow-up]: Evaluate implant survival rate from time of placement to 12-months follow-up
• Abutment survival rate [From implant placement to 12-months follow-up]: Evaluate abutment survival rate from implant placement to 12-months follow-up
• Clinician satisfaction - handling of device [After 10-days of zygomatic implant placement]: To evaluate clinician's satisfaction with handling of the device using a VAS scale (from 0-not satisfied to 100-fully satisfied)
• Clinician satisfaction - function and esthetic [At 6-months and 12-months follow-up of zygomatic implant placement]: To evaluate clinician's satisfaction with function and esthetics (using VAS scale 0-not satisfied and 100-fully satisfied)
• Technical complications [From zygomatic implant placement until 12.months follow-up]: All technical complications will be recorded

Other outcomes

• Prosthetic survival [From placement until 12-months follow-up]: To evaluate prosthetic survival rate

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

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• Ewa Bednarek, Study director, Nobel Biocare