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The goal of this clinical trials to evaluate precision of different scanbodies in same participant group. The main guestion it aim to answer is:
1. Are the precision of the three different scanbodies used in direct digitalization the same for the produce of implant-supported prostheses?
Participants are healty and have short edentulous span in posterior region that will receive implant-supported prostheses.
Twenty-five patients receiving two implant supported restorations in treatment of short-span partial edentulism were enrolled into the study. Three different scanbodies, original, non-original and generic, were employed for direct digitalization technique. Full contour PMMA restorations were CAD/CAM fabricated from each digital record, and were evaluated in terms of implant fit, axial- and occlusal-contact. Additionally, patient's impressions for digitalization and delivery procedures were recorded using a visual analog scale. Scanbody scan recordings were subjected to reverse engineering for analytical evaluation of 3D virtual implant positioning.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Evaluation precision of different scan-bodies | Other | Three different brand scanbodies (Straumann, Medentika, 3Shape) that applied in same participant group with randomization are used in this clinical study. These three different scan bodies are digitized using an intraoral scanner. Three different temporary restorations are designed in the CAD program and three different bridges are produced with the milling technique using the temporary restoration block. Clinical and analytic evaluations were perform and primarly, seconderly outcomes were achieved. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3Shape | Device | original (Straumann), non-original (Medentika) and generic scan-bodies (3Shape) were utilized for direct digitalization using intraoral scanner with image stitching algorithm. Full contour temporary restorations were fabricated from each digital record, and were evaluated in terms of clinical and analytical. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical fit | Compatibility between the manufactured restorations and implant 0: incompatible 1: compatible | 1 year |
| occlusal contact | Restoration occlusal contact with the opposite teeth. I.Occlusal Contacts:
| 1 year |
| interface contact | Restoration interface contacts with the adjacent teeth. II. Interface Contacts:
| 1 year |
| Analytical measurement of 3D implant positions | Analytical outcomes were obtained from scan bodies using reverse engineering software used to calculate 3D implant positions. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog scale | Patient impression was done in two clinical stages, registration and restoration delivery, and a scale of five points from 0 to 100 was used. A value of 0 is set to be straightforward and 100 complex. During the registration phase, the patient's anxiety level about the direct digitalization procedure, which was explained in detail before registration, was determined. After the registration, it was asked to evaluate the difficulty of the process. The time spent for adjustment during the restoration delivery phase and the comfort feeling of the restoration after adjustment were evaluated. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fatmanur Demir, DDS | Hacettepe University Faculty of Dentistry Department of Prosthodontics Ankara, Turkey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hacettepe University Faculty of Dentistry Department of Prosthodontics | Ankara | Altındağ | 06230 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32133690 | Result | Oh KC, Park JM, Moon HS. Effects of Scanning Strategy and Scanner Type on the Accuracy of Intraoral Scans: A New Approach for Assessing the Accuracy of Scanned Data. J Prosthodont. 2020 Jul;29(6):518-523. doi: 10.1111/jopr.13158. Epub 2020 Jun 26. | |
| 31840139 | Result | Passos L, Meiga S, Brigagao V, Street A. Impact of different scanning strategies on the accuracy of two current intraoral scanning systems in complete-arch impressions: an in vitro study. Int J Comput Dent. 2019;22(4):307-319. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 10, 2022 | Feb 28, 2023 | Prot_SAP_000.pdf |
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Scan post information used for direct digitalization was not shared with the patient during the procedure.
The investigator, who performed the statistical analysis, did not learn the scan post, in which the primary and secondary data were collected, until all evaluations were completed.
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| 1 year |