Trueness of Full Arch Scans and Generated Digital Implant Models

Ain Shams University

Status: Not yet enrolling

Conditions: Denture; Complete Edentulism

Treatments: Device: digital scanning with coupled scanning aiding device; Device: conventional impression stone casts digitization; Device: Digital Implant Model assessment of accuracy

Study type: Interventional

Funder types: Other

Identifiers

NCT06281002

FDASU-RecIM112323

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 45 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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9 participants in 2 patient groups

conventional physical impressions

Active Comparator group

Description:

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.

Treatment:

Device: conventional impression stone casts digitization

optical impressions with additional geometric scanning aids coupled with the scan bodies

Experimental group

Description:

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.

Treatment:

Device: digital scanning with coupled scanning aiding device

Device: Digital Implant Model assessment of accuracy