Trueness of Full Arch Scans and Generated Digital Implant Models

NCT ID: NCT06281002

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-30

Study Completion Date

2024-12-31

Brief Summary

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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

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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

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Denture Complete Edentulism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

conventional impression stone casts digitization

Intervention Type DEVICE

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.

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.

Group Type EXPERIMENTAL

digital scanning with coupled scanning aiding device

Intervention Type 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

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Omnia Hafez Mohamed

Clinical general dentist at MOH, Master degree candidate in oral and maxillofacial prosthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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FDASU-RecIM112323

Identifier Type: -

Identifier Source: org_study_id

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