Conventional and Ultrasonic Implant Site Preparation (PI-DRI)
Immediate Loading After Conventional and Ultrasonic Implant Site Preparation: a Multicenter Randomized Controlled Clinical Trial
研究概览
地位
条件
详细说明
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Parma、意大利、43100
- Piezosurgery Academy
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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;
Exclusion Criteria:
- 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%)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:edentulism side 1
ultrasound implant site preparation
|
piezoelectric bone surgery will be used to create implant bone ostectomy
|
|
有源比较器:edentulism side 2
conventional implant site preparation
|
twist drills will be used to create implant bone ostectomy
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
implant survival rate
大体时间:two years after surgery
|
how many implant are present in mouth
|
two years after surgery
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
implant success rate
大体时间:two years after surgery
|
implant stable and fulfilling success criteria
|
two years after surgery
|
|
biomechanical complications
大体时间:two years after surgery
|
every complication linked to the crown, implant abutment structure
|
two years after surgery
|
|
marginal bone loss
大体时间:two years after surgery
|
radiographically assessed bone level
|
two years after surgery
|
合作者和调查者
调查人员
- 研究主任:Claudio Stacchi, Dr、Piezosurgery Academy
出版物和有用的链接
一般刊物
- Vercellotti T, Stacchi C, Russo C, Rebaudi A, Vincenzi G, Pratella U, Baldi D, Mozzati M, Monagheddu C, Sentineri R, Cuneo T, Di Alberti L, Carossa S, Schierano G. Ultrasonic implant site preparation using piezosurgery: a multicenter case series study analyzing 3,579 implants with a 1- to 3-year follow-up. Int J Periodontics Restorative Dent. 2014 Jan-Feb;34(1):11-8. doi: 10.11607/prd.1860.
- Esposito M, Grusovin MG, Achille H, Coulthard P, Worthington HV. Interventions for replacing missing teeth: different times for loading dental implants. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD003878. doi: 10.1002/14651858.CD003878.pub4.
- Khayat PG, Arnal HM, Tourbah BI, Sennerby L. Clinical outcome of dental implants placed with high insertion torques (up to 176 Ncm). Clin Implant Dent Relat Res. 2013 Apr;15(2):227-33. doi: 10.1111/j.1708-8208.2011.00351.x. Epub 2011 May 20.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.