NCT05315414进行中（未招募）不适用
An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Extraction Sockets and Healed Ridges - A 5 Year Follow-up
Dentsply Sirona Implants and Consumables5 个研究点 分布在 5 个国家目标入组 138 人开始时间: 2022年5月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 138
- 试验地点
- 5
- 主要终点
- Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.
研究概览
简要总结
The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.
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
- •Adult aged 18-75 years.
- •Willing and able to sign and date the informed consent form.
- •In need of an implant in position 16 to 26 or 36 to 46, and each subject can only receive one implant.
- •Deemed by the investigator as likely to present with an initially stable implant situation.
- •A stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture.
- •An adjacent tooth (root with natural or artificial crown) or an implant-supported crown mesially and distally. Exemption: If the planned implant is in the first molar position, an edentulous space is accepted distally
排除标准
- •Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation.
- •Unlikely to be able to comply with clinical investigation procedures according to investigator's judgement.
- •Unable or unwilling to return for follow-up visits for a period of 5 years.
- •Known allergy or hypersensitivity to titanium and/or stainless steel.
- •Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease.
- •Uncontrolled para-functional habits, e.g. bruxism.
- •Current need of any Guided Bone Regeneration (GBR) procedure in the planned implant area (gap filling at immediate placement and soft tissue grafting are allowed).
- •Systemic or local disease or condition that would compromise post-operative healing and/ or osseointegration.
- •Immunosuppression, use of corticosteroids, per-os or intravenous bisphosphonate use, or any other medication such as anti-resorptive therapy or monoclonal antibodies that could compromise post-operative healing and/or osseointegration.
- •Any other condition that would make the subject unsuitable for participation, including but not limited to;
- •History of radiation therapy in the head and neck region.
- •History of chemotherapy within 5 years prior to surgery.
- •Present alcohol and/or drug abuse.
- •Ongoing psychiatric illness.
- •Current smoking/use of tobacco, including e-cigarettes.
- •Any ongoing disease that would make the subject unsuitable for participation, including but not limited to;
- •Recent myocardial infarction (< 3 months*).
- •Recent cerebrovascular accident (< 3 months*).
- •Recent cardiac-valvular prosthesis placement (< 3 months*).
- •Hemorrhagic diathesis.
- •Severe liver dysfunction.
- •Known or suspected current malignancy.
- •Uncontrolled diabetes mellitus.
- •Florid infection.
- •Pregnant or breastfeeding females. (Pregnancy tests will be performed as per local requirements).
- •Previous enrolment in the present clinical investigation.
- •Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona staff and the clinical investigation site).
- •Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last 6 months that may interfere with the present clinical investigation.
- •< 3 months is a strict exclusion criterion. After 3 month it is up to the investigator to judge whether the subject is considered suitable for participation or not.
研究组 & 干预措施
Single tooth restorations
Experimental
A single, open-label group with patients in need of single tooth restorations will receive PrimeTaper EV implant system with diameters 3.6, 4.2, 4.8, 5.4 mm, and lengths 6.5, 8, 9, 11, 13, 15 and 17 mm.
干预措施: PrimeTaper EV implant (Device)
结局指标
主要结局
Implant survival, i.e. number of implants in place counted clinically, 1 year after permanent restoration.
时间窗: One year post permanent restoration (anticipated average 3 months after implant placement).
Implant survival rate is a binary variable evaluated clinically, i.e. 'Yes' or 'No' where 'Yes' means that the implant is still in place and 'No' means that the implant is not in place. Any implant that has been removed or lost after implant placement visit will be considered a failure, whatever the reason for removal/loss.
次要结局
- Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.(From date of implant placement (anticipated average 1 month after inclusion) to date of permanent restoration (anticipated average 3 months after implant placement).)
- Final insertion torque value for each implant at implant placement.(At date of implant placement (anticipated average 1 month after inclusion).)
- Implant survival, i.e. number of implants in place counted clinically, 2, 3, 4 and 5 years after permanent restoration.(2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).)
- Maximum insertion torque value for each implant at implant placement.(At date of implant placement (anticipated average 1 month after inclusion).)
- Change of marginal bone level up to 5 years post permanent restoration compared to permanent restoration.(At permanent restoration (anticipated average 3 months after implant placement) and 1, 2, 3 and 5 years post permanent restoration.)
- Change of probing pocket depth (PPD) in mm between permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.(At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.)
- Presence of plaque at 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.(6 months, 1, 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).)
- Investigator questionnaire for each investigational medical device after implant placement.(Immediately after implant placement (anticipated average 1 month after inclusion).)
- Implant success, i.e., number of implants documented as successful at 1, 2, 3 and 5 years after permanent restoration.(1, 2, 3 and 5 years post permanent restoration (anticipated average 3 months after implant placement).)
- Presence of bleeding on probing (BoP), at permanent restoration, and 6 months, 1, 2, 3, 4 and 5 years after permanent restoration.(At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.)
- Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies during the clinical investigation.(Up to 5 years after permanent restoration (anticipated average 3 months after implant placement).)
研究者
研究点 (5)
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