Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone: Randomized Clinical Trials.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Marginal Bone Loss
研究概览
简要总结
Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.
详细描述
Main goals.
Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.
Specific goals.
- Evaluate the marginal peri-implant bone loss after the healing period through radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year after the implants insertion.
- Evaluate the primary stability of each individual implant the day of their insertion to verify their load on the moment of surgery and also compare the values of each preparation techniques of implant bone preparation.
- Evaluate the secondary stability of each individual implant and compare the values of each preparation techniques.
- Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar.
- •3 months after the dental extraction without alveolar scar tissue remains.
- •Bone availability of at least 5mm of width and 13mm of length.
- •At least 2 to 3 mm of soft tissue for the establishment of an adequate peri-implant biological width.
- •Oclusal pattern that ensures prosthetic success.
- •Implants need to have at least a 35 N and 70 ISQ index to be loaded.
- •Index of plaque < 20% and/or inactive periodontal disease.
排除标准
- •Acute myocardial infarction in the last 2 months.
- •Uncontrolled coagulation disorders
- •Uncontrolled diabetes (HbA1c> 7.5%).
- •Radiotherapy on head/neck in the last 24 months.
- •Immunocompromised patient.
- •History of medication related to osteonecrosis of the jaws.
- •Psychiatric disorders, alcohol, drugs and large smokers (>10 cigarrillos).
- •Plaque index > 20%.
- •Need for simultaneous or previous peri-implant guided bone regeneration procedures.
研究组 & 干预措施
Piezoelectric osteotomy
Implant placement by piezoelectric osteotomy
干预措施: Piezoelectric osteotomy. (Procedure)
Conventional drilling
Implant placement by conventional drilling
干预措施: Conventional drilling (Procedure)
结局指标
主要结局
Marginal Bone Loss
时间窗: 12 months
To compare MBL measured using radiographs.
Marginal Bone Loss
时间窗: 1 month
To compare MBL measured using radiographs.
Marginal Bone Loss
时间窗: 3 months
To compare MBL measured using radiographs.
Marginal Bone Loss
时间窗: 6 months
To compare MBL measured using radiographs.
次要结局
- Primary stability(Baseline)
- Bleeding of probing(3,6,12 months)
- Secondary stability(3 months)
- Survival rate(3,6,12 months)
- Probing depth(3,6,12 months)
研究者
Isabel Godoy Reina
Professor of Master of Periodontology and Implant Dentistry, PhD student.
Universidad de Granada