Trueness of Full Arch Scans and Generated Digital Implant Models

Complete Edentulism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06281002
• Other study ID #: FDASU-RecIM112323
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 9
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Complete Edentulism
• Denture

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trueness of full arch digital scans when additional geometric scanning aids are coupled with the scan bodies.	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	2 months
Secondary	Trueness of the generated 3D-printed digital implant models.	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.	2 months