NCT05079542进行中（未招募）不适用
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.
University of Geneva, Switzerland0 个研究点目标入组 60 人开始时间: 2015年10月5日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 主要终点
- Implant survival
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Implant survival
时间窗: 5 years
Survival of the implant
Survival of the reconstructions
时间窗: 5 years
Survival of prosthetic reconstruction
次要结局
- Mesial and distal bone levels(5 years)
- ISQ values(3 months)
- Soft tissue volume(5 years)
- Technical and biological outcomes of the restorations(5 years)
- Recording the need of GBR procedures(8 weeks)
研究者
Dr. med. dent. Malin Strasding
Principal Investigator
University of Geneva, Switzerland
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