A Prospective, Non-interventional, Clinical Study to Evaluate the Safety, Performance and Clinical Benefits of Implants With TiUltra Technology and Associated Prosthetic Components
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
- 试验地点
- 32
- 主要终点
- Marginal bone level change
研究概览
简要总结
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement
详细描述
Primary Objective: The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.
Secondary Objective:The secondary objectives of this clinical investigation are:
- To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits
- To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit
- To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit
- To evaluate soft tissue outcome (as measured by bleeding index, plaque index and gingival index) to 5 years from definitive prosthetic placement.
- To evaluate SADE, USADE, ADE and DD from implant insertion until 5 years follow-up visit.
Study design: This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The study devices are divided into four groups:
- Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)
- Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP)
- Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP)
- Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP)
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject signed the informed consent
- •Subject is between 18 and 70 years of age
- •Subjects presented with the need of single, multiple or full arch implant rehabilitation in any region of the mouth.
- •Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU).
- •Subject with sufficient bone volume for implant placement.
- •Subject is compliant with good oral hygiene as judged by the clinician.
排除标准
- •Anatomical conditions discovered during surgery preventing the use of intended implant system.
- •Subjects with history of allergy or adverse reactions to any materials used
- •Uncontrolled diabetes (subjects with history of diabetes mismanagement and/or known A1c level above 8%)*
- •Heavy smokers (>10 cigarettes per day)
- •Severe bruxism or dysfunctional tendencies
- •Previous oro-maxillo facial radiotheraphy
- •Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
- •Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous radiation.
- •Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
- •Infections in the planned implantation site or adjacent tissue.
- •Documented complete remission of >3 years if history of non-oral cancer.
- •Pregnant or lactating women at the time of implant insertion. *Assessment of A1C level is not required unless it is standard of care at the treating clinic
结局指标
主要结局
Marginal bone level change
时间窗: Definitive prosthetic delivery to 5-years follow-up
The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.
次要结局
- Sost tissue outcome- Ginigval index(Definitive prosthetic delivery to 5-years follow-up)
- Prsothetic suviival and success rate(Definitive prosthetic delivery to 5-years follow-up)
- Sost tissue outcome- Bleeding index(Definitive prosthetic delivery to 5-years follow-up)
- Sost tissue outcome- Plaque index(Definitive prosthetic delivery to 5-years follow-up)
- Marginal bone level change(Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years)
- Cumulative Survival rate/Cumulative success rate(Definitive prosthetic delivery to 5-year follow-up)
- Adverse event(Implant insertion to 5-years follow-up)