NCT06281002

Trueness of Full Arch Scans and Generated Digital Implant Models

Assessment of Accuracy of Full Digital Workflow in Fabrication of Four-Implant Screw-Retained Mandibular Hybrid Prostheses

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Ain Shams University · Academic / Other
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Denture
• Complete Edentulism

Interventions

Type	Name	Description
DEVICE	conventional impression stone casts digitization	Nine conventional physical open tray impressions will be poured into a hard dental stone to obtain nine definitive implant casts with conventional implant analogs to act as a reference comparator. Impressions will be digitized to reference STL files.
DEVICE	digital scanning with coupled scanning aiding device	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.
DEVICE	Digital Implant Model assessment of accuracy	The nine STL files of optical scanning will serve as reference data for comparison with the digitized DIMs to evaluate the accuracy of representation of the actual position of implants in the software.

Timeline

• Start date: 2024-04-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2024-02-28
• Last updated: 2024-03-06