Implant/Abutment Module Stability: a RCT Comparing Original vs Compatible Connections (Estabilidad Del módulo Implante/Pilar: ECA Comparando Conexiones Originales vs Compatibles).
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Biological complications
研究概览
简要总结
Together with materials and type of retention, the stability of the implant abutment connection represents one of the key factor for the success rate of an implant supported restoration. The recent diffusion of high quality and easy to use CAD/CAM systems has contributed to market launch of a number of competing companies that offer the so called "clonical" or "compatible" restorative components. Although they are claimed to be identical, the original abutments are supposed to present maximum accuracy and consequently lower microleakage.
The aim of the present randomized controlled trial will be to analyze the implant abutment junction stability comparing implant-supported crowns restored with original components and compatible non-original abutments.
The hypothesis is that original components will present significantly better stability than non-original abutments.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The devices will have the same shape and will be delivered to the surgeon unlabeled in an identical sterile envelope.
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
- •Any healthy patient scheduled for an implant-supported restoration will be considered for inclusion in this study, independently of the implant and prosthetic protocols used.
排除标准
- •general medical contraindications to oral surgery (American Society of Anesthesiologist, ASA, class III or IV),
- •patients <18 years of age,
- •smoking habit (>10 cigarettes/day),
- •sites with acute infection or requiring regenerative procedures,
- •Full Mouth Plaque Score
- •Full Mouth Bleeding Score >25 %,
- •pregnant and lactating.
研究组 & 干预措施
Original CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments.
干预措施: Painkillers (Drug)
Original CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments.
干预措施: Original CAD/CAM prosthetic abutment (Device)
Original CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments.
干预措施: Local anesthesia (Procedure)
Original CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments.
干预措施: Mouthwashes (Drug)
Original CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and original (Sweden&Martina) CAD/CAM abutments.
干预措施: Implant placement (Device)
Compatible CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
干预措施: Compatible CAD/CAM abutment (Device)
Compatible CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
干预措施: Local anesthesia (Procedure)
Compatible CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
干预措施: Painkillers (Drug)
Compatible CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
干预措施: Mouthwashes (Drug)
Compatible CAD/CAM abutment
Patients will be rehabilitated using Sweden&Martina implants and compatible (New Ancorvis) CAD/CAM abutments.
干预措施: Implant placement (Device)
结局指标
主要结局
Biological complications
时间窗: 1 year
Proportion of cases with peri-implant disease.
Biomechanical complications
时间窗: 1 year
Proportion of cases with fracture or loosening of screws
次要结局
- Bleeding on Probing(1 year)
- Probing Pocket Depth(1 year)
- Modified Plaque Index(1 year)
- Microbial loads(1 year)
研究者
David Peñarrocha Oltra
Assistanat Postdoctoral Lecturer (Profesor Ayudante Doctor)
University of Valencia