NobelZygoma TiUltra Implant System Study

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство NobelZygoma™ 0° CC TiUltra™implant ; NobelZygoma™ 45° Ext Hex TiUltra™ implant
  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
• Устройство 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
  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

Первичные конечные точки

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

Вторичные конечные точки (12)

• PREMs [Срок оценки: At pre-treatment; and after 10 days, 6- and 12-months of zygomatic implant placement]
• Pain assessment [Срок оценки: 10 days after zygomatic implant placement]
• Patient satisfaction [Срок оценки: 10 days, 6-months and 12-months after zygomatic implant placement]
• OHIP-21 [Срок оценки: At pre-treatment and after 10 days, 6-months and 12-months of zygomatic implant placement]
• Keratinized mucosa status [Срок оценки: At 6-months and 12-months follow-up of zygomatic implant placement]
• Modified Bleeding Index (mBI) [Срок оценки: At 6- and 12-months follow-up of zygomatic implant placement]
• Biological [Срок оценки: From implant placement until12-months after implant placement]
• Adverse Events [Срок оценки: From implant placement until 12-months after implant placement]
• Implant survival rate [Срок оценки: From time of placement to 12-months follow-up]
• Abutment survival rate [Срок оценки: From implant placement to 12-months follow-up]
• Clinician satisfaction - handling of device [Срок оценки: After 10-days of zygomatic implant placement]
• Clinician satisfaction - function and esthetic [Срок оценки: At 6-months and 12-months follow-up of zygomatic implant placement]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

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

Швейцария · 1 центр

• Hirslanden Medical Center — Aarau

Публикации

• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT07258940 · T-197

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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