Trueness of Full Arch Scans and Generated Digital Implant Models

Not Applicable

Not yet recruiting

• Conditions: Complete Edentulism; Denture
• Interventions: Device: conventional impression stone casts digitization; Device: digital scanning with coupled scanning aiding device; Device: Digital Implant Model assessment of accuracy

• Registration Number: NCT06281002
• Lead Sponsor: Ain Shams University

Brief 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.

Study Timeline

• Study First Submitted: 2024-02-20
• Study First Submitted QC: 2024-02-20
• Study First Posted: 2024-02-28
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-06
• Study Start: 2024-04
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• 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-4.
• good oral hygiene and motivation

Exclusion Criteria

• 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.
• Smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
optical impressions with additional geometric scanning aids coupled with the scan bodies	Digital Implant Model assessment of accuracy	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.
conventional physical impressions	conventional impression stone casts digitization	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.
optical impressions with additional geometric scanning aids coupled with the scan bodies	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.

Primary Outcome Measures

Name	Time	Method
Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.	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

Secondary Outcome Measures

Name	Time	Method
Trueness of the generated 3D-printed digital implant models.	2 months	Based on the obtained optical scans, CAD software will be used to produce CAM files of definitive implant casts, the polymer casts will be printed and the digital implant analogs will be installed in their corresponding positions in the printed DIMs.; The digitized data of the DIMs will be compared to their corresponding reference STL files of optical scans to check the accuracy of the generated digital implant models.