Prospective, Multi-center, Randomized, Single Blinded and Parallel Controlled Clinical Investigation to Assess the Performance, Safety and Benefit of the Wishbone HA Medical Device, a Deproteinized Bovine Bone Material, as a Bone Graft Substitute in the Socket Management Indication Requiring Bone Grafting Procedure Before Implant Placement.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 96
- 试验地点
- 10
- 主要终点
- Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
研究概览
简要总结
This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket.
详细描述
In this study, the subjects will be pseudonymized and randomized in a 1:1 ratio between WHA and the selected comparator device Bio-Oss®. The sample size of the study has been computed based on a non-inferiority test between Bio- Oss® and WHA for device performance for the filling of extraction sockets. A total of 96 subjects will be enrolled.
The results will be used to demonstrate the safety, performance and benefit of the product WHA in the socket indication in compliance with the MDR 2017/745.
The endpoints are all accurately based on objective measurements:
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Primary Endpoint: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
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Secondary Endpoints:
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Evaluation of implant stability at placement.
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Assessment of bone density at the time of implant insertion.
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Implant osteointegration at 3months after implant placement.
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Evaluation of implant survival and success at 3-, 6-and12-months, 3-and 5- years after implant placement.
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Rate of all Adverse Device Events (incidence, type, relatedness, severity, seriousness) from the time of grafting procedure up to 5 years after implant placement.
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Patient satisfaction 6- and 12-months after implant placement.
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Evaluation of the Sulcus index (peri-implant marginal tissue health status) at 6- and 12-months after implant placement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
Patients will not be informed of their randomization assignment until the 1 year post implant placement follow-up visit. At this timepoint, the primary endpoint will have been achieved (at the implant placement visit) as well as the majority of the secondary endpoints. After the bone grafting surgery, all patients will receive an identic implant cart that does not break the blinding of the study. 1 year after implant placement, the patients will receive their definitive implant cart.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject signed the informed consent form;
- •The subject is ≥ 18 and ≤ 80 years old at surgery;
- •The subject is in need of a tooth extraction prior to implant placement;
- •All four bony walls are preserved after extraction;
- •Minimum 8mm height of bone;
- •Minimum 7mm thickness of lingual vestibular;
- •The subject is willing and able to comply with all investigation related procedures (such as exercising oral hygiene and attending all follow-up visits);
- •Full-mouth bleeding score (FMBS) lower than 25%;
- •Full-mouth plaque score (FMPI) lower than 25%.
排除标准
- •Subject with an acute infection (abscess) at the surgical site;
- •Subject with untreated periodontitis or periodontal disease;
- •Subject with autoimmune diseases or subjects that had received or were currently receiving treatment with antiresorptive drugs (e.g., bisphosphonates), or steroid therapy;
- •Subject who is pregnant or breastfeeding;
- •Subjects is a heavy smoker (>10 cigarettes a day);
- •Subject with an inability to conduct basic oral hygiene (poor oral hygiene and motivation);
- •Subject with metabolic diseases (diabetes, hyperparathyroidism, osteomalacia);
- •Subject with severe renal dysfunction and severe liver disease;
- •Subject with known severe osteoporosis;
- •Subject with multiple sclerosis and/or acromegaly;
- •Subject follows radiotherapy;
- •Subject with psychiatric disorders or under substance abuse (drug or alcohol);
- •Subject who participates in other clinical trials interfering with the present protocol;
- •Mucosal diseases in the areas to be treated.
结局指标
主要结局
Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
时间窗: one year
Bone thickness will be measured using CBCT scan 4 months after the bone augmentation procedure and just before implant insertion. The most apical point from the extraction socket defined at baseline will be set as a reference. The vertical reference line will be drawn in the center of the extraction socket crossing the apical reference point. The horizontal reference line is drawn perpendicular to the vertical line crossing the apical reference point. Based on these marks, 3 measurements will be done at 1, 3 and 5 mm from the top of the crest.
次要结局
- Assessment of the implant osteointegration after implant placement(15 months)
- Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement.(2 years)
- Assessment of the bone density at implant placement.(one year)
- Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire.(2 years)
- Evaluation of the implant primary stability.(one year)
- Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement(5 years)
- Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness(5 years)
- Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement.(2 years)