A Randomized Controlled Trial Comparing Titanium Grade V (KS) Versus Titanium Grade IV (TS) Implants for the Treatment of Edentulous Mandible
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 主要终点
- Rate of implant stability
研究概览
简要总结
To evaluate the clinical and radiographic outcomes of KS implants used to rehabilitate edentulous mandible with dental-retained overdentures, and to compare it with same treatment on TS implants
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
A blinded (when possible) outcome assessor will evaluate all the outcomes and will take the radiogram for centralized analysis.
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 edentulous patient (post-extractive sites must to be healed from at least 3 months), with sufficient bone height and width in the anterior mandible (between canines) to allow the placement of two implants of 3.5 mm diameter of at least 8.5 mm of length.
- •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).
- •In case of post-extractive sites, they must have been healing for at least 3 months before being treated in the study.
排除标准
- •Exclusion criteria
- •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.
- •Previous guided bone reconstruction at the intended implant sites.
- •Uncontrolled diabetes.
- •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
Rate of implant stability
时间窗: Up to 5 years
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 at initial loading. At 1,3 and 5 years after loading, individual implants will be manually tested for stability. Once the single crowns will be screwed, their stability will be assessed by rocking the crown with the handles of two dental instruments.
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.
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 reaso
Number of complications
时间窗: Up to 5 years
echnical (fracture of the framework and/or the veneering material, screw loosening, etc.) and/or biologic (pain, swelling, suppuration, peri-implantitis, etc.) complications will be considered.
次要结局
- Peri-implant marginal bone level changes(At 1,3 and 5 years)
- Patient satisfaction(At 1,3 and 5 years)
研究者
Marco Tallarico
Assistent Professor
Università degli Studi di Sassari