RCT of BLT Implants Used for Immediate vs Early Placement, Restored With Ceramic Crowns on Titanium Bonding Bases. (BLT)
2021年10月3日 更新者:Dr. med. dent. Malin Strasding、University of Geneva, Switzerland
Randomized Controlled Clinical Trial of BLT Implants Used for Immediate vs Early Placement and Restored With Lithium-disilicate Glass Ceramic or Sintered Zirconia Crowns on Titanium Bonding Bases.
The purpose of this study is to assess the outcome of a new bone level tapered implant when inserted either following an immediate placement protocol or an early placement approach and restored with single crowns out of two different ceramic materials adhesively cemented on a titanium bonding base.
研究概览
地位
主动,不招人
研究类型
介入性
注册 (实际的)
60
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
22年 及以上 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
Subjects must require extraction and replacement of a tooth in the maxillary or mandibular anterior or premolar region with an implant reconstruction.
- ≥22 years of age
- Patient in a good general health
- Adequate bone quality and quantity for one-stage implant placement
- Patient with physical status PS1 and PS2 (according to Physical Status Classification System of the American Society of Anesthesiologists; Attachment 5)
- Adequate bone height of at least 1mm longer than the length of the study implant
- Capable of providing written informed consent.
- Obtained informed consent from the patient and committed to the study and the required follow-up visits.
Exclusion Criteria:
Patients with a high lip line / smile line
- Thin mucosal biotype
- Anatomically not sufficient bone volume or height at implant site to achieve primary stability of the implant
- Pronounced esthetic expectations
- Lack of keratinized mucosa at implant site (< 2mm oral and buccal)
- Women of childbearing potential with a positive urine pregnancy test
- Patients with inadequate oral hygiene or persistent intraoral infection
- Smokers exceeding 10 cigarettes / day, or equivalent; patients chewing tobacco
- Severe bruxism or clenching habits
- Presence a systemic disease or allergy (e.g. conditions requiring chronic routine prophylactic use of antibiotics or prolonged use of steroids, history of rheumatic heart disease, bacterial endocarditis, cardiac vascular anomalies, prosthetic joint replacements, etc.)
- Presence or history of receiving intravenous or subcutaneous antiresorptive agents, such as bisphosphonates
- Presence of mucosal diseases (e.g. erosive lichen planus) in the localized area around the study implant
- Patients with history of renal failure, bleeding disorders, metabolic bone disorder, uncontrolled endocrine disorders, HIV infection, leucocyte dysfunction and deficiencies, neoplastic disease requiring the use of radiation or chemotherapy, etc.
- Patients with alcohol or drug abuse
- Participation in any other clinical trial (drug or device) less that 30 days before implant insertion
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
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:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:Immediate implant placement
Implant is placed immediately after tooth extraction.
|
Implant surgery on different time points
|
|
有源比较器:Delayed implant placement
Implant is placed 8 weeks after tooth extraction.
|
Implant surgery on different time points
|
|
实验性的:Lithium disilicate crown
Crown out of Lithiumdisilicate is inserted onto the implant.
|
Tooth restoration with a certain material
|
|
有源比较器:Zirconia Crown
Crown out of Zirconia is inserted onto the implant.
|
Tooth restoration with a certain material
|
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
大体时间:5 years
|
Survival of the implant
|
5 years
|
|
Survival of the reconstructions
大体时间:5 years
|
Survival of prosthetic reconstruction
|
5 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mesial and distal bone levels
大体时间:5 years
|
Peri-implant bone level changes
|
5 years
|
|
ISQ values
大体时间:3 months
|
Measurement of ISQ values during implant surgery and at insertion of crown
|
3 months
|
|
Soft tissue volume
大体时间:5 years
|
Intra-oral digital scans with volumetric software will be used for the soft tissue volume measurements.
|
5 years
|
|
Technical and biological outcomes of the restorations
大体时间:5 years
|
Presence of fractures/chipping, retention loss, screw loosening
|
5 years
|
|
Recording the need of GBR procedures
大体时间:8 weeks
|
Need of GBR procedure or not during surgery
|
8 weeks
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2015年10月5日
初级完成 (预期的)
2025年3月3日
研究完成 (预期的)
2025年3月3日
研究注册日期
首次提交
2021年3月17日
首先提交符合 QC 标准的
2021年10月3日
首次发布 (实际的)
2021年10月15日
研究记录更新
最后更新发布 (实际的)
2021年10月15日
上次提交的符合 QC 标准的更新
2021年10月3日
最后验证
2021年10月1日
更多信息
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