Comparison of Osstem KS SA Versus KS BA for the Patient With Type 2 Diabetes: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Implant failure
研究概览
简要总结
The aim of this randomized controlled trial is to evaluate whether is better to place KS Osstem Implants with BA or SA surface placed in patients with type 2 diabetes, and to compare clinical and radiographic data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
patients, centralized radiographic assessor, outcome assessors, and the statistical advisors will be blind to the used implants
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Patients of at least 18 years old able to sign an informed consent.
- •Patients with at least a single tooth loss in the maxilla or mandible. Patient will provide only one site for the research. Implant sites must allow the placement of implants of at least 3.5 mm (upper laterals and lower incisors); 4 mm (central incisors, canines, and premolars) or 4.5 (molars) mm of diameter and at least 7 mm of length.
- •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).
- •Patients with a plaque index (PI) of less than, or equal to 25% at the time of surgery.
- •In case of post-extractive sites, they must have been healing for at least 4 months before being treated in the study.
- •Patients with controlled type 2 diabetes mellitus with a duration of at least 1 years of disease evaluation and baseline glycated hemoglobin A1c (HbA1c) values between 7.5% and 12% at the time of implant placement will be included.
排除标准
- •General contraindications to implant surgery (except for type two diabetes in test group).
- •Patients irradiated in the head and neck area.
- •Immunosuppressed or immunocompromised patients (except for type two diabetes in test group).
- •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 (except for type two diabetes in test group).
- •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.
研究组 & 干预措施
BA Surface test group
Common procedures: Implants placement in subjects with type 2 diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation.
Test procedure: use of implant with BA surface in type 2 diabetic patients.
干预措施: Implant placement (Device)
SA Surface control group
Common procedures: Implants placement in subjects with type 2 diabetes who have lost at least one tooth element and need of a prosthetic implant-supported rehabilitation. Control procedure: use implant with SA surface in type 2 diabetic patients
干预措施: Implant placement (Device)
结局指标
主要结局
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 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.
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.
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.) 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)
- Implant stability quotient (ISQ)(1,3 and 5 years)
研究者
Marco Tallarico
Assistent Professor
Università degli Studi di Sassari