The Efficacy of New SOI Implant Surface for Immediately Loaded, Post-extractive Versus Delayed Implants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Number of implant failure
研究概览
简要总结
The aim of this randomized controlled trial is to compare the clinical and radiographic of immediately loaded, immediate (post-extractive, test group) versus delayed (control group) implants with new SOI surface
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
One "blinded (when possible)" independent assessor
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
- •Any patient with at least one hopeless tooth in the mandible or maxilla, located between premolars, with intact post extractive alveolus. The implants must to engage at least 3 (mandible) to 5 (maxilla) mm of residual native bone over the socket.
- •Patients with 18 years or older, and able to sign an informed consent.
- •Smokers will be included and categorized into: 1) non smokers; 2) moderate smokers (smoking up to 10 cigarettes/day); 3) heavy smokers (smoking more than 11 cigarettes/day). Heavy smokers will be excluded.
- •Biotype will be categorized in thin (≤1 mm), medium (>1 - <2 mm) or thick (≥2 mm).
排除标准
- •General contraindications to implant surgery.
- •Patients irradiated in the head and neck area.
- •Immunosuppressed or immunocompromised patients.
- •Patients treated or under treatment with intravenous amino-bisphosphonates.
- •Patients with untreated periodontitis.
- •Patients with poor oral hygiene and motivation.
- •Uncontrolled diabetes.
- •Heavy smokers.
- •Pregnancy or nursing.
- •Substance abuser.
- •Psychiatric problems or unrealistic expectations.
- •Lack of opposite occluding dentition in the area intended for implant placement.
- •Patients with infection and or inflammation in the area intended for implant placement.
- •Patients participating in other studies, if the present protocol cannot be properly adhered to.
- •Patients referred only for implant placement and cannot be followed ant the treating centre.
- •Patients unable to be followed for 5 years
结局指标
主要结局
Number of implant failure
时间窗: Up to 5 years
defined as implant mobility and/or any infection dictating implant removal, and/or implant fracture and/or any other mechanical complication rendering the implant unusable. The stability of each individual implant will be measured by the local blinded outcome assessors manually tightening the screws with a torque of 30 Ncm at abutment connection, immediately loading, at 1,3 and 5 years after loading for the partial fixed prostheses. Once the single crowns will be cemented, their stability will be assessed by rocking the crown with the handles of two dental instruments.
Number of complications
时间窗: Up to 5 years
Technical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complication will be considered.
Number of prosthesis failure
时间窗: Up to 5 years
Whether it will not be possible to place the prosthesis because of implant failure or a prosthesis that has to be remade for any reason.
次要结局
- Rate of peri-implant marginal bone level changes(At 1,3 and 5 years)
- Valuation of patient satisfaction(At 1,3 and 5 years)
- Number of PES score(1,3 and 5 years)
- Valuation of soft tissue thickness and amount of keratinized tissue(1,3 and 5 years)
- Rate of implant stability quotient (ISQ)(Up to 5 years)
研究者
Marco Tallarico
Assistant professor
Università degli Studi di Sassari