Clinical Investigation Title: An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of OmniTaper EV Implants in Extraction Sockets and Healed Ridges - A 5-year Follow-up
概览
- 阶段
- 不适用
- 干预措施
- OmniTaper EV implants
- 疾病 / 适应症
- Jaw, Edentulous
- 发起方
- Dentsply Sirona Implants and Consumables
- 入组人数
- 139
- 试验地点
- 6
- 主要终点
- Implant survival rate 1 year after permanent restoration by counting implant in place 1 year after permanent restoration
- 状态
- 进行中（未招募）
- 最后更新
- 2个月前
概览
简要总结
This clinical study, funded by the company Dentsply Sirona, is being carried out to see if the newly developed tooth implant "OmniTaper EV" is safe, effective and functions as intended when replacing a lost or removed tooth. The OmniTaper EV implant is a further development of existing dental implants. It is made of titanium, a metal that is well tolerated by the human body, which has been successfully used in dental implants for more than 40 years. All components used in this study are available on the market, are CE-marked and will be used according to intended use and approved instructions.
The study involves at 11 planned clinic visits including follow-up visits 6 months and annually until 5 years after installation of the permanent crown. after over a period of about five and a half years. The treatment method and healing period may vary depending on the individual case and treatment plan and additional visits may therefore need to be scheduled. The visits and procedures are the same as standard of care and no procedures will be done just for purpose of research.
The study aims to recruit about 137 men and women from six clinics across Europe (Germany, UK and Switzerland) and participants can only receive one study implant each. Participation is entirely voluntary and participants can choose to withdraw from the study at any time, without giving a reason. The decision to decline or withdraw participation will not affect participants future treatment or care
研究者
入排标准
入选标准
- •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 (2nd and 3rd molars are excluded), and each subject can only receive one implant.
- •Deemed by the PI/Subinvestigator 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 PI's/Subinvestigator's judgement.
- •Unable or unwilling to return for follow-up visits for a period of 5 years.
- •Severe non-compliance to CIP as judged by the PI/Subinvestigator and/or Dentsply Sirona.
- •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, prior or current use of oral or intravenous bisphosphonate, or any other medication such as anti-resorptive therapy or monoclonal antibodies that could compromise post-operative healing and/or osseointegration.
研究组 & 干预措施
Single tooth restorations
A single, open-label group with patients in need of single tooth restorations will receive an OmniTaper EV implant system available in the following sizes: diameter 3.4, 3.8, 4.5 and 5.5 mm and lengths 8, 9.5, 11, 13, 15 and 18 mm.
干预措施: OmniTaper EV implants
结局指标
主要结局
Implant survival rate 1 year after permanent restoration by counting implant in place 1 year after permanent restoration
时间窗: 1 year after permanent restoration (which is estimated to occur approximately 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
- Implant success, i.e., number of implants documented as successful at 1, 3 and 5 years after permanent restoration.(1, 2, 3 and 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).)
- Maintenance of marginal bone levels (MBL).(At permanent restoration (which is estimated to occur approximately 3 months after implant placement) and at 1, 3 and 5 years after PR..)
- Implant survival rate at 3 and 5 years after permanent restoration by counting implant in place.(3 and 5 year after permanent restoration (which is estimated to occur approximately 3 months after implant placement).)
- Occurrence of Device Deficiencies (DDs)(From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).)
- Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.(From date of implant placement (which is estimated to occur approximately 1 month after enrollment).)
- Final and maximum insertion torque value for each implant at implant placement.(At date of implant placement (which is estimated to occur approximately 1 month after enrollment).)
- Surgeon's assessment of implant stability and confidence at implant placement for each implant.(Immediately after implant placement (which is estimated to occur approximately 1 month after enrollment).)
- PPD (Probing Pocket Depth)(At PR (which is estimated to occur approximately 3 months after implant placement) and at 1, 2, 3, 4 and 5 years after PR.)
- Plaque(6 months, 1, 2, 3, 4 and 5 years after PR (which is estimated to occur approximately 3 months after implant placement).)
- Occurrence of Adverse Events (AEs)(From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).)
- Bleeding on Probing (BoP)(At PR (which is estimated to occur approximately 3 months after implant placement) and at 1, 2, 3, 4 and 5 years after PR.)
- Occurrence of Adverse Device Effects (ADEs)(From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).)