Clinical Outcome of Two-piece Zirconia Implants in Immediate Implant Placement - a Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change of ISQ
研究概览
简要总结
The purpose of the study is to test whether a two-piece zirconia implant is as reliable in the indication of immediate implant placement as a standard titanium implant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking procedures are only applicable for the outcomes assessor. Due to the different colors of the compared implants, blinding procedures are not applicable for the investigator or the participants.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients giving informed consent to participate in the clinical trial and fulfil the following criteria will be included in the investigation:
- •good oral hygiene standard;
- •good general health;
- •18 years or older;
- •non-smokers;
- •presence of single-tooth or multiple gaps in the mandible or the maxilla;
- •intact facial bone wall;
- •sufficient bone volume to support an implant of at least 10 mm length.
- •Teeth with removable periapical lesions are included.
排除标准
- •Primary exclusion criteria are as follows:
- •parafunctional habits;
- •active periodontitis;
- •acute or chronic medical conditions for which implant therapy has always been considered a contraindication: uncontrolled diabetes (HbA1c >8.0%), mucosal disease, untreated periodontitis, immunological disorders, active malignancy, alcoholism, condition after radiation therapy to the head and neck area and antiresorptive therapy.
- •Secondary exclusion criteria will be applied at surgical procedure:
- •loss of facial bone wall due to extraction procedure;
- •insufficient primary stability (less than 32Ncm insertion torque).
研究组 & 干预措施
Two-piece zirconia implants
Immediate dental implant placement will be performed by using the new two-piece zirconia implant Straumann® Pure Ceramic Two Piece Implant
干预措施: Implant Straumann® Pure Ceramic Two Piece Implant (Device)
Two-piece titanium implants
Immediate dental implant placement will be performed by using the conventional two-piece titanium implant Neoss® ProActive Tapered Implant
干预措施: two-piece titanium implant Neoss® ProActive Tapered Implant (Device)
结局指标
主要结局
Change of ISQ
时间窗: initial, 6 and 12 months after surgical procedure
Implant stability quotient. A transducer (smart-peg sensor) will be installed on the top of the implant to measure ISQ with resonance frequency analysis. ISQ will be measured from 4 different sites (facial, lingual, mesial, distal) and calculated as mean of measurements.
Change of PTV
时间窗: initial, 6 and 12 months after surgical procedure
Periotest value, Damping capacity assessment. For Periotest values, a customizable healing abutment will be inserted to assess damping capacity.
次要结局
- Change of BOP(initial, 6 and 12 months after surgical procedure)
- Mean insertion time(at time of surgery)
- Complications - esthetic(12 months after surgical procedure)
- Change of marginal bone loss(6 and 12 months after surgical procedure)
- Change of PES(6 and 12 months after surgical procedure)
- Complications - biological(12 months)
- Complications - technical(12 months after surgical procedure)
- Change of PROM(initial, 12 months after surgical procedure)
- Change of width of keratinized mucosa(initial, 12 months after surgical procedure)
- Gingival biotype(initial)
- Complications - biological(at time of surgical procedure, 2 weeks, 6 months and 12 months after surgical procedure)
- Complications - biological(at time of surgical procedure)
- Complications - biological(2 weeks)
- Complications - biological(6 months)
- Complications - technical(at time of surgical procedure)
- Complications - technical(2 weeks)
- Complications - technical(6 months)
- Complications - esthetic(at time of surgical procedure)
- Complications - esthetic(2 weeks)
- Complications - esthetic(6 months)