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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.
The main issues to evaluate are:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional physical impressions | Active Comparator | 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. |
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| optical impressions with additional geometric scanning aids coupled with the scan bodies | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional impression stone casts digitization | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| digital scanning with coupled scanning aiding device | 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. |
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| Digital Implant Model assessment of accuracy | 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. |
|
| 2 months |