Effect of Open Tray Versus Digital Impressions on the Passivity and Prosthetic Complications of Full Arch Screw-retained Prosthesis - A Randomized Control Trial Study
试验速览
- 阶段
- 不适用
- 入组人数
- 92
- 主要终点
- Passivity of seating of PolyMethylMethAcrylate (PMMA) tryin prosthesis
研究概览
简要总结
The importance of this trial lies in testing if intraoral digital impressions will increase the accuracy of impressions of full arch implant cases over conventional impression techniques thus improving the passivity of full arch screw retained prosthesis and decreasing the prosthetic complications in turn.
详细描述
In this study intraoral digital impressions will be used for scanning full arch implant cases to minimize the variables in the conventional technique, finally the study will investigate if the intraoral digital impressions will increase the accuracy of impressions of full arch implant cases thus improving the passivity and decreasing prosthetic complications of screw retained prosthesis for a long-term success compared to open tray impression technique.
Primary outcome will be evaluation of the passivity of PMMA (Polymethyl methacrylate ) try-in , while secondary outcomes will be detecting prosthetic complications (screw loosening , prosthesis fracture) and treatment time for both groups.
Eligibility criteria:
Inclusion criteria:
- Completely edentulous patients with sufficient inter-arch space to receive fixed prosthesis (Crown height space 9-15 mm per arch)
- Completely edentulous patients with 4 implants in mandible and/ or 6 implants in maxilla
- sufficient bone volume for implant placement without graft a confirmed by CBCT
- adequate zone of keratinized mucosa ( > 2mm width)
- All genders
- Acceptable oral hygiene
- Cooperative patients
- Controlled systemic diseases ( Diabetes, hypertension)
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Completely edentulous patients with sufficient inter-arch space to receive fixed prosthesis (Crown height space 9-15 mm per arch)
- •Completely edentulous patients with 4 implants in mandible and/ or 6 implants in maxilla
- •sufficient bone volume for implant placement without graft a confirmed by CBCT
- •adequate zone of keratinized mucosa ( > 2mm width)
- •All genders
- •Acceptable oral hygiene
- •Cooperative patients
- •Controlled systemic diseases ( Diabetes, hypertension)
排除标准
- •Completely edentulous patients with sufficient inter-arch space to receive fixed prosthesis (Crown height space 9-15 mm per arch)
- •Completely edentulous patients with 4 implants in mandible and/ or 6 implants in maxilla
- •sufficient bone volume for implant placement without graft a confirmed by CBCT
- •adequate zone of keratinized mucosa ( > 2mm width)
- •All genders
- •Acceptable oral hygiene
- •Cooperative patients
- •Controlled systemic diseases ( Diabetes, hypertension)
结局指标
主要结局
Passivity of seating of PolyMethylMethAcrylate (PMMA) tryin prosthesis
时间窗: 3-4 months after implants placement after final impressions for implants
the screw retained prosthesis can be considered passive when it does not generate static loads and strains within the prosthesis or in the surrounding bone structure measured using Single screw test (measuring unit : binary - yes/No)
次要结局
- Prosthetic complications including screw loosening and prosthesis fracture(At 3, 6 months after delivery of final prosthesis)
- Treatment time(5-6 months after implants placement ( at the last visit ))
研究者
Shymaa Hassan Hussein Mohamed Elsharkawy
MSc faculty of Dentistry, Cairo university (2019)
Cairo University