Assessment of Accuracy of Full Digital Workflow in Fabrication of Four-Implant Screw-Retained Mandibular Hybrid Prostheses
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 9
- 主要终点
- Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
研究概览
简要总结
The goal of this clinical trial study is to evaluate the accuracy of the full digital workflow for four-implant, screw-retained mandibular hybrid prostheses in patients with completely edentulous mandible.
详细描述
The main issues to evaluate are:
- The trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
- The trueness of the generated 3D-printed DIMs.
Participants will provide two types of impressions to compare after osteointegration; the first will be conventional open tray impression used as a gold standard comparator, the second will be digital scans with additional geometric scanning aids coupled with the scan bodies.
Accordingly generated 3D-printed DIMs will be printed and compared to the digital image to evaluate its accuracy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients having a completely edentulous lower arch that could be restored by fixed screw-retained implant hybrid dentures.
- •Patients having a substantial bone height and width at prospective implant sites to install four standard-size inter-foraminal implants.
- •Sufficient crown height space according to criteria of all-on-
- •good oral hygiene and motivation
排除标准
- •Patients with bad oral hygiene.
- •Patients with limited mouth opening.
- •Vulnerable groups.
- •Uncooperative patients.
- •Patients receiving or undergoing radiotherapy or chemotherapy.
- •Patients with systemic diseases affecting bone metabolism.
研究组 & 干预措施
conventional physical impressions
Nine physical open tray impressions will be poured into a hard dental stone to obtain nine definitive implant casts with conventional implant analogs.
The impressions will be scanned to provide a gold standard reference STL files.
干预措施: conventional impression stone casts digitization (Device)
optical impressions with additional geometric scanning aids coupled with the scan bodies
Nine optical impressions will be obtained while additional geometric scanning aids are coupled with the scan bodies to get nine CAD/CAM 3D-printed polymer casts with digital implant analogs.
干预措施: digital scanning with coupled scanning aiding device (Device)
optical impressions with additional geometric scanning aids coupled with the scan bodies
Nine optical impressions will be obtained while additional geometric scanning aids are coupled with the scan bodies to get nine CAD/CAM 3D-printed polymer casts with digital implant analogs.
干预措施: Digital Implant Model assessment of accuracy (Device)
结局指标
主要结局
Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.
时间窗: 2 months
The optical impressions will be obtained by an intraoral scanner while the scan abutments are coupled with 3D geometric scanning aids and seated in positions. special digital software will be used to compare the trueness of virtual implant positions in the obtained digital scan STL files to the digitized reference positions in the patients' digitized conventional stone model
次要结局
- Trueness of the generated 3D-printed digital implant models.(2 months)
研究者
Omnia Hafez Mohamed
Clinical general dentist at MOH, Master degree candidate in oral and maxillofacial prosthodontics
Ain Shams University