NL-OMON51681尚未招募不适用
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 - C-PT-21-001
Gulje Mondzorg bv0 个研究点目标入组 25 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •For inclusion in the clinical investigation subjects must meet all of the
- •following criteria:
- •1. Adult aged 18-75 years.
- •2. Willing and able to sign and date the informed consent form.
- •3. In need of an implant in position 16 to 26 or 36 to 46, and each subject can
- •only receive one
- •4. Deemed by the investigator as likely to present with an initially stable
- •implant situation.
- •5. 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.
- •6. 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
- •Exclusion criteria
- •All exclusion criteria apply at inclusion with a final eligibility verification
- •prior to implantation, but
- •exclusion criteria number 4 also applies during the entire clinical
- •investigation period.
- •Any of the following is regarded as a criterion for exclusion from the clinical
- •investigation:
- •1. Not willing to participate in the clinical investigation or not able to
- •understand the content of
- •the clinical investigation.
- •2. Unlikely to be able to comply with clinical investigation procedures
- •according to
- •investigator*s judgement.
- •3. Unable or unwilling to return for follow-up visits for a period of 5 years.
- •4. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply
- •5. Known allergy or hypersensitivity to titanium and/or stainless steel.
- •6. Uncontrolled pathological process in the oral cavity, e.g. untreated rampant
- •uncontrolled periodontal disease.
- •7. Uncontrolled para-functional habits, e.g. bruxism.
- •8. Current need of any Guided Bone Regeneration (GBR) procedure in the planned
- •area (gap filling at immediate placement and soft tissue grafting are allowed).
- •9. Systemic or local disease or condition that would compromise post-operative
- •healing and/
- •or osseointegration.
- •10. Immunosuppression, use of corticosteroids, per-os or intravenous
- •bisphosphonate use, or
- •any other medication such as anti-resorptive therapy or monoclonal antibodies
- •compromise post-operative healing and/or osseointegration.
- •11. 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.
- •12. 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.
- •13. Pregnant or breastfeeding females. (Pregnancy tests will be performed as
- •requirements).
- •14. Previous enrolment in the present clinical investigation.
- 另有 10 项未显示
研究者
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