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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Complete Edentulism; Denture
• Intervention / Treatment: Device: conventional impression stone casts digitization; Device: digital scanning with coupled scanning aiding device; Device: Digital Implant Model assessment of accuracy

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 Type: Interventional
• Enrollment (Estimated): 9
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Intraoral scanning; Digital implant models; Edentulous mandible; Screw retained prosthesis; Geometric scanning aids
• Other Study ID Numbers: FDASU-RecIM112323

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No