NCT04063878进行中（未招募）不适用
A Prospective, Multicenter Study on Acuris™ - Conometric Concept for Single Tooth Restoration. A 5-year Follow-up Study
Dentsply Sirona Implants and Consumables11 个研究点 分布在 6 个国家目标入组 160 人开始时间: 2019年7月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 11
- 主要终点
- Prosthetic Survival
研究概览
简要总结
The purpose of this study is to evaluate the outcome of prosthetic survival of the Acuris conometric concept 1 year after permanent restoration, since this is a new mode of retention using friction for seating the crown of single tooth restorations without using cement or screws.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject aged between 18-75 years
- •Subject signed and dated the informed consent form
- •In need of an implant replacing a missing tooth in position 17 to 27 or 37 to 47, and each subject can only receive one study implant.
- •Neighbouring tooth to the planned implant must have
- •a natural root or an implant supported restoration mesially
- •a natural root or an implant supported restoration distally Exemption: If the planned implant is in the second molar position, an edentulous space is accepted distally.
- •Presence of natural tooth, partial prosthesis and/or implant supported restoration in the opposite jaw in contact with the planned crown
- •Deemed by the investigator as likely to present an initially stable implant situation
排除标准
- •Unlikely to be able to comply with study procedures, according to Investigators judgement
- •Subject is not willing to participate in the study or not able to understand the content of the study
- •Involvement in the planning and conduct of the study
- •Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.
- •Unable or unwilling to return for follow-up visits for a period of five years
- •Simultaneous participation in another clinical study, or former participation in a clinical study during the last 6 months that may interfere with the present study
- •Previous enrolment in the present study
- •Uncontrolled pathological process in the oral cavity
- •Known or suspected current malignancy
- •History of radiation therapy in the head and neck region within 12 months prior to surgery
- •Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration
- •Uncontrolled diabetes mellitus
- •Corticosteroids, iv bisphosphonates or any other medication that could influence post-operative healing and/or osseointegration
- •Current need for major bone grafting and/or augmentation in the planned implant area (minor grafting and soft tissue grafting are allowed)
- •Smoking more than 10 cigarettes per day, present alcohol or drug abuse
- •Known pregnancy at implant installation (Only applicable for sites in United States and Canada)
结局指标
主要结局
Prosthetic Survival
时间窗: 1 year after permanent restoration
Evaluation of presence of original permanent restoration, remained retention between abutment and final cap, and occurrence of fracture/loss of abutment. Prosthetic survival will be categorized as No/Yes. It will be categorized as "Yes" if all of the following criteria are fulfilled: * Permanent restoration is remaining in situ. * No loss of conometric retention between abutment and final cap. * No fracture of abutment. * No loss of abutment.
次要结局
- Implant Survival(1, 3 and 5 years after permanent restoration)
- Prosthetic Survival(3 and 5 years after permanent restoration)
- Bleeding on Probing(1, 3 and 5 years after permanent restoration)
- Marginal Bone Levels Alterations(1, 3 and 5 years after permanent restoration)
- Plaque(1, 3 and 5 years after permanent restoration)
- Probing Pocket Depth(1, 3 and 5 years after permanent restoration)
研究者
研究点 (11)
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