Идёт набор NCT06960460

Study Evaluating the Performance and Safety in the Medium and Long Term of Global D ZygoFixU System

Без фазы С лечением Dental Implants

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Dental implant surgery with ZygoFixU implants.
Кому может быть актуально: Состояния в реестре: Dental Implants. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция, Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective, Multicenter, European Clinical Investigation Evaluating the Short and Medium-term Performance and Safety of the Global D ZygoFixU Implant-prosthetic System

Обзор

Global D has developed an zygomatic implant prosthetic system (ZygoFixU range): zygomatic implants, prosthetic parts and associated instruments. These devices have a design similar to other zygomatic implants on the market and are therefore not innovative. These non-CE marked devices are assessed during investigation 2302-G-ZYGO-C for their performance and for their short- and medium-term safety. These implants will be placed using specific instruments, by oral or cranio-maxillofacial surgeons with significant experience in the placement of zygomatic implants and trained in clinical research.

Подробное описание

Study design: Interventional pivotal study involving humans, prospective with continuous series, multicentre, European, open-label, non-comparative.

Clinical investigation classification: class 2 clinical investigation according to ANSM in France, aiming at establishing the conformity of a class IIb, non CE-marked medical device. Clinical investigation to demonstrate device compliance, in accordance with Article 62.1 of the MDR.

Investigators: Patient recruitment and follow-up will be carried out by dental surgeons or oral surgeons/stomatologists in France and Italy. 11 sites will participate in the CI in 2 countries (Italy and France).

Objective: To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.

Population: Adult male or female patients, whose growth and development of the maxillary bone is complete, partially or completely edentulous with advanced atrophy of the maxillary bone (grades IV, V and VI according to the Cawood and Howell classification if used).

Вмешательства

Другое Dental implant surgery with ZygoFixU implants
Adult patients who have had dental implant surgery.

Первичные конечные точки

To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively. [Срок оценки: 1 year]

Вторичные конечные точки (6)

To assess the performance of the ZygoFixU implant-prosthetic system via the survival rate [Срок оценки: 2, 3, 4 years and 5 years]
the success rate at 1 year postoperatively, 2, 3, 4 years and 5 years postoperatively - the quality of life of patients preoperatively, at 6-8 months postoperatively, 1 year postoperatively, 2, 3, 4 years and 5 years postoperatively. [Срок оценки: 12 months, 2, 3, 4 years and 5 years]
To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects) [Срок оценки: 2, 3, 4 years and 5 years]
To assess surgeon satisfaction with the use of the ZygoFixU implant-prosthetic system. [Срок оценки: After surgery]
To assess patient satisfaction with the ZygoFixU implant-prosthetic system [Срок оценки: 1 year]
To assess the safety of the ZygoFixU implant-prosthetic system via: - immediate and delayed complications (adverse device events and effects, defects) [Срок оценки: 2, 3, 4 years and 5 years]

Критерии участия

Критерии включения

Adult male or female patient,
Patient whose growth and development of the maxillary bone is complete according to the investigator's judgement,
Partially or completely edentulous patient,
Patient with advanced maxillary atrophy (grades IV, V and VI according to the Cawood and Howell classification if used),
Patient requiring implant treatment with Global D zygomatic implants (placement of two or four implants),
Patient with acceptable oral opening (>3 cm measured anteriorly),
Patient able to read, understand and answer the quality-of-life questionnaire of the investigation and able to give consent,
Patient agreeing to comply with the protocol design and to send his/her follow-up data, even in the event of a move,
Patient having signed the consent form,
In France, patient affiliated to a social security scheme.

Критерии исключения

Patient's state of health at enrolment:

General contraindications to implant surgery
Patient with zygomatic bone disease
Patient with untreated periodontal disease
Patient with acute or chronic infection in the implant placement area, or systemic infection, including acute or chronic maxillary sinusitis
Patient with acute or chronic inflammation in the implant placement area, or systemic inflammation,
Patient with uncontrolled diabetes (unstable blood glucose)
Patient with immunodeficiencies or using immunosuppressants
Patient who received radiation of more than +70 Gy to the head and neck region
Patient using intravenous aminobisphosphonates within 5 years prior to surgery
Patient who are smokers (>10 cigarettes/day) or with alcohol or drug addiction
Person placed under legal protection (this includes guardianship, curatorship and legal protection).
Pregnant or breastfeeding women

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

Здоровые добровольцы: Нет