Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- implant survival rate
研究概览
简要总结
multi center study with randomized controlled trial design, split mouth
详细描述
The present study has been designed as a multicenter prospective randomized controlled trial design. Fifteen clinical centers will treat patients by inserting and immediately loading implants with two different surgical protocols. Each patient will receive two identical implants: after randomization, the test site will be prepared by ultrasonic microvibrations and the control site using twist drills. Both implants will be loaded with a provisional crown within 48 hours after surgery. For each inserted implant, collection of experimental parameters will be required up to 2 years after surgery.
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 (Investigator, Outcomes Assessor)
盲法说明
treatment method is masked till the surgical procedure, during which, both surgeon and patient are informed
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •indications for two implant-supported single crowns with immediate loading in the upper or lower arch (in the incisor, canine or premolar area), based on accurate diagnosis and treatment planning; 2) implants can be in the same or in different quadrants; 3) implant sites must be performed in similar bone quality (i.e. both maxillary or mandibular); 4) the bone crest must be healed (at least three months elapsed after tooth loss); 5) presence of a residual bone crest with an adequate volume to allow the insertion of a 3.8x11.5 mm implant without any kind of regenerative procedure; 6) age of the patient >18 years; 7) patient willing and fully capable to comply with the study protocol; 8) written informed consent given;
排除标准
- •acute myocardial infarction within the past 2 months;
- •uncontrolled coagulation disorders;
- •uncontrolled diabetes (HBA1c > 7.5%);
- •radiotherapy to the head/neck district within the past 24 months;
- •immunocompromised patient (HIV infection or chemotherapy within the past 5 years);
- •present or past treatment with intravenous bisphosphonates;
- •psychological or psychiatric problems;
- •alcohol or drugs abuse Local exclusion criterion is the presence of uncontrolled or untreated periodontal disease (full mouth plaque score and full mouth bleeding score > 25%)
研究组 & 干预措施
edentulism side 1
ultrasound implant site preparation
干预措施: ultrasound implant site preparation (Procedure)
edentulism side 2
conventional implant site preparation
干预措施: conventional implant site preparation (Procedure)
结局指标
主要结局
implant survival rate
时间窗: two years after surgery
how many implant are present in mouth
次要结局
- implant success rate(two years after surgery)
- biomechanical complications(two years after surgery)
- marginal bone loss(two years after surgery)
研究者
Mr. Claudio Stacchi, DDS, MSc
President of International Piezosurgery Academy
International Piezosurgery Academy