NCT04054219Unknown不适用
Prospective, Single Center, Pivotal Investigation to Investigate Efficacy and Safety of WISHBONE HA, Used as Bone Graft Substitute for Different Indications Where Bone Grafting Procedures Are Required Before Implant Placement.
Wishbone SA1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2019年7月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Measure of the bone augmentation success
研究概览
简要总结
Evaluation of efficacy and safety of Wishbone HA as bone graft substitute, a pre-market clinical investigation.
Group1: Extraction Socket management Group 2: Sinus lift
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject signed the informed consent form
- •Subject is ≥18 and ≤ 80 years old.
- •Subject presented in need of:
- •tooth extraction without estimated need of connective tissue grafting OR
- •defect in the upper jaw requiring sinus lift with or without lateral augmentation procedure prior to implant placement
- •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%
- •The subject displays no clinical contraindications for a 2-stage surgical procedure
排除标准
- •Less than 2 mm of remaining keratinized mucosa
- •Severe vertical resorption of the crest (except internal resorptions, i.e. expanded sinuses)
- •Ridge with prior bone augmentation procedure performed (i.e ridge preservation)
- •Any disorders in the planned implant area such as previous tumors, chronic bone disease.
- •Alcohol or drug abuse as noted in subject records or in subject history.
- •Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc).
- •Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history.
- •Smoking: >10 cigarettes per day
结局指标
主要结局
Measure of the bone augmentation success
时间窗: 6 months after procedure
Group 2 - Sinus lift: Efficacy endpoint based on the bone augmentation success (bone gain after bone augmentation procedure) measured by Cone Beam CT
Measure of the bone augmentation success
时间窗: 4 months after procedure
Group 1 - Extraction Socket Management: Efficacy endpoint based on the bone augmentation success (bone gain after bone augmentation procedure) measured by Cone Beam CT
次要结局
- Implant success(1 year after after definitive prosthesis delivery)
- Papilla index evaluation(1 year after definitive prosthesis delivery)
- Plaque index evaluation(1 year after definitive prosthesis delivery)
- Patient Oral health profile evaluation(1 year follow-up visit)
- Implant survival(1 year after after definitive prosthesis delivery)
- Procedure success: ability to successfully perform the implants placement(6 months after procedure)
- Assessment of the bone quality and bone quantity(6 months after procedure)
- Safety endpoint: Collection of all device related adverse events(6 months after procedure)
- Site preparation: need for under or over preparation of the osteotomy(6 months after procedure)
- Keratinized mucosa evaluation(1 year after definitive prosthesis delivery)
- Bleeding index evaluation(1 year after definitive prosthesis delivery)
- Safety endpoint: Collection of all device related adverse events(4 months after procedure)
- Procedure success: ability to successfully perform the implants placement(4 months after procedure)
- Site preparation: need for under or over preparation of the osteotomy(4 months after procedure)
- Assessment of the bone quality and bone quantity(4 months after procedure)
研究者
研究点 (1)
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