Fully Guided Versus Conventionally Guided Implant Placement by Dental Students. A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Linear and angular accuracy of implant placement
研究概览
简要总结
Patients where placement of a single implant will be treated by senior dental students under close supervision of experienced spcialists. All implant treeatments will be categorized as "straight forward"according to the SAC classification. The patients will be randomized to have the implants placed using a fully guided or a convetionally guided protocol.
Outcome parameters include accuracy of implant placement compared to an ideal implant position, patient- and student-reported outcome.
详细描述
Study design and participants The study is designed with two commonly used procedures for implant placement. Two well-known, but different workflows are used: a digital using primarily a digital workflow and a conventional workflow using primarily an analog procedure. In our daily student education, the latter has been used, but to examine the feasibility and quality of using a full digital work, the present study will compared two accepted and documented workflows. For making a reliable comparison, a prospective, randomized clinical study is planned within our normal schedule for student education. Thirty-six patients are already recruited and pre-screened to clinical teaching in implant dentistry on from the September to December 2019 on Department of Odontology. All 36 patients in the need of implant-supported single tooth restorations and without any contraindications for implant dentistry. All cases are selected to be "straight-forward" cases possible to be rehabilitated by dental students.
Sample calculation (Power of the study): A sample size of 28 subjects (14 in each group) is needed to detect a difference in patient-reported outcome (VAS-scale values for digital versus analog impression) of 30 % , with a 5 % risk of type I and 20 % risk of type II errors and SD = 2. With a maximum drop-out of up to 8 patient a sample size of 36 is endeavored.
The inclusion criteria for this study are the following:
- Patients of more than 18 years of age
- Patients with a need of one or more single-tooth implants in the molar or the premolar region
- Natural healthy neighboring teeth without need of restorations
- Sufficient bone-volume for placing an implant without bone- or soft tissue augmentation
Exclusion criteria are the following:
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
The assesor was blinded to the group allocation of the participant
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 of more than 18 years of age
- •Patients with a need of one or more single-tooth implants in the molar or the premolar region
- •Natural healthy neighboring teeth without need of restorations
- •Sufficient bone-volume for placing an implant without bone- or soft tissue augmentation
排除标准
- •Heavy smokers (more than 10 cigarettes per day)
- •Uncontrolled diabetes
- •Metabolic bone disorders
- •History of radiotherapy of the head and neck
- •Recent chemotherapy
- •Use of drugs influencing bone or soft tissue healing (e.g. high doses of antiresorptive medication, steroids or anti-inflammatory drugs)
- •Additional oral surgery in the region of interest
结局指标
主要结局
Linear and angular accuracy of implant placement
时间窗: 1 year
Linear (in mm) and angular (in degrees) deviations from an ideal implant position determined by three experienced investigators.
次要结局
- Patient-reported outcome(1 year)
研究者
Simon Storgård Jensen
Professor
University of Copenhagen