Prospective, Multicenter, European Clinical Investigation Evaluating the Short and Medium-term Performance and Safety of the Global D ZygoFixU Implant-prosthetic System
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 99
- 试验地点
- 5
- 主要终点
- To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
To assess the performance of the ZygoFixU implant-prosthetic system by measuring the survival rate at 1 year postoperatively.
时间窗: 1 year
Measurement of the survival rate of Global D zygomatic implants 1 year after the surgical procedure by the rate of in situ implants.
次要结局
- To assess the performance of the ZygoFixU implant-prosthetic system via the survival rate(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)(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.(12 months, 2, 3, 4 years and 5 years)
- To assess surgeon satisfaction with the use of the ZygoFixU implant-prosthetic system.(After surgery)
- To assess patient satisfaction with the ZygoFixU implant-prosthetic system(1 year)