Prospective, Multicenter, Non-randomized, Controlled Clinical Study Utilizing Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 16
- 主要终点
- To evaluate implant survival rate at 1 year after final restoration attachment (screw retained when feasible) with single and multiple (fixed bridges) PrimeTaper EV implant(s) utilizing non-guided versus guided surgery
研究概览
简要总结
A 510k approved dental device for subjects requiring single or multiple tooth replacement with implants where immediate restoration/loading is preferred.
详细描述
The rationale for this study is to provide scientific data on the clinical performance and patient reported outcomes of the PrimeTaper EV implant when utilizing non-guided vs guided surgical technique. The PrimeTaper EV implant has the OsseoSpeed surface, which is especially indicated for use in soft bone applications where implants with other surface treatments may be less effective.
The main interests of this study are to assess the survival and the success rates of the implants supporting maxillary or mandibular fixed single or 2-fixture restorations after 1, 2, 3, 4 and 5 years in function
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject ≥25 years.
- •Subject has signed and dated the informed consent form prior to any study procedures.
- •History of either a healed edentulous area or single or multiple teeth requiring extraction and in need of a single or fixed bridge prosthetic restoration and where immediate restoration/loading is preferred.
- •Opposing jaw in the treatment area meets any of the following stable occlusal conditions:
- •Complete denture Partial removable denture Fixed bridges and/or crowns Natural dentition
排除标准
- •Any of the following is regarded as a criterion for exclusion from the study (all criteria apply at study inclusion, but criteria numbered 1-4 also apply during the entire study period):
- •Unlikely to be able to comply with study procedures, according to the Investigator's judgment.
- •Subject is not willing to participate in the study or not able to understand the content of the study.
- •Involved in the planning and conduct of the study.
- •Unable or unwilling to return for follow-up visits for a period of 5 years.
- •Has an uncontrolled pathological process in the oral cavity (e.g. untreated periodontal disease, uncontrolled caries, severe malocclusion, etc.).
- •Known or suspected current malignancy.
- •History of radiation therapy in the head and neck region.
- •History of chemotherapy within 5 years prior to surgery.
- •Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration (e.g., uncontrolled diabetes mellitus as reported by the subject).
- •Use of systemic corticosteroids, IV bisphosphonates or any other medication that could compromise post-operative healing and/or osseointegration.
- •Current alcohol and/or drug abuse.
- •Smoking more than 10 cigarettes of any type per day.
- •Current need for major bone grafting and/or augmentation in the planned implant area (esthetic augmentation and minor facial grafting are allowed).
- •Known pregnancy, or plans to become pregnant during the study period of 5 years
- •Participation in another clinical study within the previous 6 months that may interfere with the present study.
- •Post-surgical Exclusion criteria
- •Insufficient primary stability, as judged by the investigator, of the implant(s).
- •Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.
研究组 & 干预措施
Single Arm
There are no arms in the study, it is a non randomized, controlled study
干预措施: PrimeTaper EV (Device)
结局指标
主要结局
To evaluate implant survival rate at 1 year after final restoration attachment (screw retained when feasible) with single and multiple (fixed bridges) PrimeTaper EV implant(s) utilizing non-guided versus guided surgery
时间窗: 1 year after final restoration
Number of remaining implants counted clinically and radiographically, i.e. 'Yes' or 'No' for each implant where 'Yes' means that the implant is still remaining and 'No' means that the implant is not remaining.
次要结局
- Implant stability by manual clinical examination(throughout study, up to the 5 year follow up)
- Implant survival rate(2, 3, 4, and 5 years after final restoration attachment)
- Condition of the peri-implant mucosa (Suppuration by visual inspection).(measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,)
- Prosthetic survival(5 years after final restoration attachment)
- Maintenance of marginal bone levels on patient- and implant level.(throughout study up to the 5 year follow up visit)
- Condition of the peri-implant mucosa (Plaque Index)(measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,)
- Condition of the peri-implant mucosa (Recession)(measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,)
- Condition of the peri-implant mucosa.(measured at 12 days, 20 weeks, 1,2,3,4,5 years)
- Prosthetic success(5 years after final restoration attachment.)
- Implant success(throughout study up to the 5 year follow up visit)
- Patient Reported Outcomes (PROs)(20 weeks, 6 months, years 1,2,3,4,5)
- Investigator Assessment of the Implant-Prosthetic Complex(20 weeks and 5 years.)