Prosthetic Fit Improving With Splint Implant Impressions: Double-blind, Randomised Clinical Trial of Accuracy and Materials.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Implant failure
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of heavy Vinyl PolySiloxane (VPS) and splinted implants impression (Study Group, SG) technique versus plaster implant impression (Control Group, CG) technique, in 12 edentulous patients rehabilitated with the All-on-4/6 concept and Procera® Implant Bridge (P.I.B.). A longitudinal, double blinded, randomised clinical trial (RCT) was designed to evaluate the accuracy of the impression. All patients were monitored from implant placement until prosthetic loading.
详细描述
The aim of the present study was to investigate the accuracy of pick-up, splinted implants, and heavy VPS impression techniques (Aquasil Putty DECA™ and Aquasil Ultra Light Viscosity (LV) Regular Set, Dentsply International Inc, Caulk, USA); to compare two splint materials for implants: Primopattern LC gel (Primotec, Bad Homburg, Germany), and Smart Dentin Replacement (SDR™, Dentsply International Inc, Caulk, USA); to examine the clinical factors affecting the accuracy of implant impressions; to test the tension-free fit of the new scanner and software NobelProcera™ (NobelBiocare, AB, Göteborg, Sweden) titanium frameworks.The hypothesis to demonstrate is that all impression techniques and used materials reduce time for final restoration and improve the accuracy of the impression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 years or older.
- •Both genders.
- •Fully edentulous patients.
- •Both maxilla and mandible.
- •Dental implant rehabilitation utilizing the All-on-4 concept at least 8 weeks before impression.
- •External hex dental implant.
- •Patients with ability to understand and sign the informed consent prior to starting the study.
- •Adequate oral hygiene.
- •Immediate functional loading.
- •Implant stability quote value =/> 65 from implant placement to final prosthetic rehabilitation.
排除标准
- •Failure of one or more inclusion criteria.
研究组 & 干预措施
Snow white Plaster 2
Test
干预措施: Snow white plaster 2 (Procedure)
Primopattern LC gel + PVS
Control
干预措施: Primopattern LC gel + PVS (Procedure)
结局指标
主要结局
Implant failure
时间窗: Up to 5 years after implant placement
An implant was consid- ered to be a failure if it was lost owing to mobility, implant fracture and/or any infection requiring implant removal.
次要结局
- Chair-time(4 to 5 months after implant placement (baseline))
- Inter-implants distance between groups(4 to 5 months after implant placement (baseline))
研究者
Marco Tallarico
Principal investigator
Hospital San Pietro Fatebenefratelli