Accuracy of Half-guided Implant Placement With Machine-driven or Manual Insertion: a Prospective, Randomized Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Global apical implant position deviation
研究概览
简要总结
The aim of the present prospective randomized controlled study is to compare the accuracy of implant placement performed either with a surgical motor or a torque wrench as part of a half-guided surgical protocol after maxillary sinus floor augmentation.
详细描述
Implant insertion with half-guided surgical protocol was utilized by surgical motor (machine-driven group) or torque wrench (manual group) in the maxilla. Forty patients were randomly divided in two study groups; 20 implants were inserted with a surgical motor and 20 implants with a torque wrench. After the healing period, accuracy comparison method between planned and actual implant positions was performed based on digital intraoral scan. Coronal, apical and angular deviation parameters, insertion time and maximum insertion torque was evaluated.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Patients were not aware whether implant were placed with a contra-angled handpiece or with a torque wrench. 3D implant position accuracy evaluation was performed blinded, randomization sequence was revealed after analysis.
入排标准
- 年龄范围
- 29 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •at least one edentulous maxillary premolar or molar site treated successfully by sinus floor elevation with a xenogenic bone substitute (cerabone, botiss biomaterials, Zossen, Germany) confirmed by preoperative cone-beam computed tomography
- •full- mouth plaque and bleeding scores (FMPS and FMBS) <20%
- •good patient compliance (including willingness to participate in the follow-up procedures)
- •signed informed consent
排除标准
- •clinically relevant diseases (e.g.: diabetes, rheumatism, cancer)
- •systemic steroid or bisphosphonate use
- •acute or chronic inflammatory processes
结局指标
主要结局
Global apical implant position deviation
时间窗: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Horizontal coronal implant position deviation
时间窗: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Global coronal implant position deviation
时间窗: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Horizontal apical implant position deviation
时间窗: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
Angular implant position deviation
时间窗: 3 months after implant placement
Measurement: comparison of planned and actual implant position in a virtual model. Tool: Linear measurement with Amira 5.4.0 (Thermo Fisher Scientific, USA). Unit: mm
次要结局
- Duration of implant insertion(During implant insertion)
- Implant insertion torque(During implant insertion)
研究者
Balint Molnar
Dr. Balint Molnar DMD, PhD, associate professor
Semmelweis University