Edentulous MaxillaNCT07258940
NobelZygoma TiUltra Implant System Study
A study testing NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant and 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 in people with Edentulous Maxilla and Maxillary Bone Loss, run by Nobel Biocare at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Edentulous Maxilla, Maxillary Bone Loss, Atrophic Maxilla
- What is being tested?
- NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant and 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Jun 2026to 1 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site
Universitiy of Verona, Unit of Stomatology and Maxillo-Facial Surgery
Verona, 37134
Antonio D Agostino, Prof, +41795407703, claudia.diasazevedof@envistaco.com
Antonio D Agostino, Prof
Switzerland1 site
Hirslanden Medical Center
Aarau, 5000
Dennis Rohner, Dr., +41795407703, claudia.diasazevedof@envistaco.com
Dennis Rohner, Dr
About this study
Official title: A 1-year Prospective Multicenter Clinical Investigation to Assess Safety, Performance and Clinical Benefits of the NobelZygoma TiUltra Implant System in the Rehabilitation of Severely Atrophic Maxillae
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.
Read the detailed description
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.
- Conditions
- Edentulous Maxilla, Maxillary Bone Loss, Atrophic Maxilla
- Being tested
- NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant, 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
- Keywords
- "zygomatic implants"; "zygoma implants"
- Medical subject headings
- Atrophic Maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implantDevice
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 RPDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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:
- 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.
- There is a clinically significant worsening in symptoms, demonstrated by a ≥12-point increase in the total SNOT-22 score from baseline (pre-treatment).
- 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.
Measured: At 12-months follow-up of zygomatic implant insertion
Secondary outcomes (13)
PREMs
Evaluate patient reported experience measures (PREMs) from pre-treatment to 12-month follow-up using Likert scale
Measured: At pre-treatment; and after 10 days, 6- and 12-months of zygomatic implant placement
Pain assessment
Assess patient reported pain at postoperative visit using VAS scale (from 0 (no pain) to 100 (worst pain possible)
Measured: 10 days after zygomatic implant placement
Patient satisfaction
Assess patient satisfaction with function and esthetics using VAS scale (from 0 - not satisfied to 100 fully satisfied
Measured: 10 days, 6-months and 12-months after zygomatic implant placement
OHIP-21
Evaluate oral health-related quality of life using OHIP-21 questionnaire from pre-treatment to 12-month follow-up.
Measured: At pre-treatment and after 10 days, 6-months and 12-months of zygomatic implant placement
Keratinized mucosa status
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
- =Mucosa surrounding the implant is partially keratinized
- = The entire mucosa surrounding the implant is keratinized
Measured: At 6-months and 12-months follow-up of zygomatic implant placement
Modified Bleeding Index (mBI)
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
- Isolated bleeding spots visible.
- Blood forms a confluent red line on the margin.
- Heavy or profuse bleeding.
Measured: At 6- and 12-months follow-up of zygomatic implant placement
Biological
Biological complications will be recorded
Measured: From implant placement until12-months after implant placement
Adverse Events
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.
Measured: From implant placement until 12-months after implant placement
Implant survival rate
Evaluate implant survival rate from time of placement to 12-months follow-up
Measured: From time of placement to 12-months follow-up
Abutment survival rate
Evaluate abutment survival rate from implant placement to 12-months follow-up
Measured: From implant placement to 12-months follow-up
Clinician satisfaction - handling of device
To evaluate clinician's satisfaction with handling of the device using a VAS scale (from 0-not satisfied to 100-fully satisfied)
Measured: After 10-days of zygomatic implant placement
Clinician satisfaction - function and esthetic
To evaluate clinician's satisfaction with function and esthetics (using VAS scale 0-not satisfied and 100-fully satisfied)
Measured: At 6-months and 12-months follow-up of zygomatic implant placement
Technical complications
All technical complications will be recorded
Measured: From zygomatic implant placement until 12.months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Jun 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Edentulous 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, interventional, multicenter, single cohort study
- Masking
- None (open label)
- Enrolment
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nobel Biocare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ewa Bednarek, Study director, Nobel Biocare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258940
- Sponsor's protocol ID
- T-197
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. As per data protection regulation in EU participant's identity should be kept confidential. As per informed consent and GDPR consent, participant is informed that their data will be securely stored in EDC system in EU and analyzed in Switzerland by the sponsor. As per EU and Switzerland data protection regulations, access to participant's data should only be given for the sponsor, regulatory authorities and ethic committee members. Study results will be disseminated through peer-reviewed publications and/or conference presentations. Summary results will be shared (e.g. via publication or posting results in ClinicalTrials.gov)
Publications
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.
PubMed 32724927Hirsch 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.
PubMed 15332178Davo 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.
PubMed 32050501Borgonovo 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.
PubMed 33160924Aparicio 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.
PubMed 35359196
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 1-year Prospective Multicenter Clinical Investigation to Assess Safety, Performance and Clinical Benefits of the NobelZygoma TiUltra Implant System in the Rehabilitation of Severely Atrophic Maxillae
- ClinicalTrials.gov ID
- NCT07258940
- Acronym / sponsor ID
- T-197
- Conditions
- Edentulous Maxilla, Maxillary Bone Loss, Atrophic Maxilla
- Keywords
- "zygomatic implants"; "zygoma implants"
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Nobel BiocareIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 2 Dec 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, interventional, multicenter, single cohort study
| Arm | Type | Receives |
|---|---|---|
| NobelZygoma TiUltra implant system in the rehabilitation of severely atrophic maxillae | Other | 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 RPParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
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 |
|---|---|---|
| NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implantAll 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. | Device | 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 RPAll 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 | Device | NobelZygoma TiUltra implant system in the rehabilitation of severely atrophic maxillae |
Primary outcome
Maxillary sinusitis at 12-months post-implant placement
Time frame: 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.
13 secondary outcomes
PREMs
Time frame: At pre-treatment; and after 10 days, 6- and 12-months of zygomatic implant placement
Pain assessment
Time frame: 10 days after zygomatic implant placement
Patient satisfaction
Time frame: 10 days, 6-months and 12-months after zygomatic implant placement
OHIP-21
Time frame: At pre-treatment and after 10 days, 6-months and 12-months of zygomatic implant placement
Keratinized mucosa status
Time frame: At 6-months and 12-months follow-up of zygomatic implant placement
Modified Bleeding Index (mBI)
Time frame: At 6- and 12-months follow-up of zygomatic implant placement
Biological
Time frame: From implant placement until12-months after implant placement
Adverse Events
Time frame: From implant placement until 12-months after implant placement
Implant survival rate
Time frame: From time of placement to 12-months follow-up
Abutment survival rate
Time frame: From implant placement to 12-months follow-up
Clinician satisfaction - handling of device
Time frame: After 10-days of zygomatic implant placement
Clinician satisfaction - function and esthetic
Time frame: At 6-months and 12-months follow-up of zygomatic implant placement
Technical complications
Time frame: From zygomatic implant placement until 12.months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Background: PubMed 32724927Yalcin 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.
- Background: PubMed 15332178Hirsch 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.
- Background: PubMed 32050501Davo 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.
- Background: PubMed 33160924Borgonovo 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.
- Background: PubMed 35359196Aparicio 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.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. As per data protection regulation in EU participant's identity should be kept confidential. As per informed consent and GDPR consent, participant is informed that their data will be securely stored in EDC system in EU and analyzed in Switzerland by the sponsor. As per EU and Switzerland data protection regulations, access to participant's data should only be given for the sponsor, regulatory authorities and ethic committee members. Study results will be disseminated through peer-reviewed publications and/or conference presentations. Summary results will be shared (e.g. via publication or posting results in ClinicalTrials.gov)
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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.
Ewa Bednarek study director
Nobel Biocare
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant and 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 in people with Edentulous Maxilla and Maxillary Bone Loss, run by Nobel Biocare at 2 sites in 2 countries.
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 5 inclusion and 13 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: opening soon, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claudia D Fagundes (+41795407703, claudia.diasazevedof@envistaco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maxillary sinusitis at 12-months post-implant placement (time frame: At 12-months follow-up of zygomatic implant insertion). 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 NCT07258940, which also lists 5 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 2 Dec 2025.