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This is a single-center, ten-year, randomized controlled, split-mouth clinical trial. A total of 164 adult patients requiring full-cuspal coverage onlays will be enrolled. Each participant will receive one milled and one 3-D printed restoration, randomly assigned.
Restorations will be evaluated at 1 week, 6 months, and 1-10 years using the revised FDI criteria for indirect restorations. The primary outcome is the survival rate of the onlays.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milled | Active Comparator | Milled CAD/CAM composite restorations |
|
| 3D-printed | Experimental | 3-D printed CAD/CAM composite restorations |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| full cuspal covarage onlay | Device | Composite onlays prepared with CAD/CAM technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| The rate of survival of the onlays at the specific time points | The survival of the onlays will be assessed at the patient level with the revised FDI criteria for direct and indirect restorations. | Survival will be evaluated at specific follow-up time points (1 week, 6 months, 1 year - 10 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University, Department of Restorative Dentistry and Endodontics | Budapest | Budapest | 1088 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37067049 | Background | Sahin Z, Ozer NE, Yiotakiotaciota C, Kiotaliotacarslan MA. Mechanical Characteristics of Composite Resins Produced by Additive and Subtractive Manufacturing. Eur J Prosthodont Restor Dent. 2023 Aug 31;31(3):278-285. doi: 10.1922/EJPRD_2478Sahin08. | |
| 36504246 | Background | Hickel R, Mesinger S, Opdam N, Loomans B, Frankenberger R, Cadenaro M, Burgess J, Peschke A, Heintze SD, Kuhnisch J. Revised FDI criteria for evaluating direct and indirect dental restorations-recommendations for its clinical use, interpretation, and reporting. Clin Oral Investig. 2023 Jun;27(6):2573-2592. doi: 10.1007/s00784-022-04814-1. Epub 2022 Dec 12. |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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split-mouth
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| 29570020 | Background | Alzraikat H, Burrow MF, Maghaireh GA, Taha NA. Nanofilled Resin Composite Properties and Clinical Performance: A Review. Oper Dent. 2018 Jul/Aug;43(4):E173-E190. doi: 10.2341/17-208-T. Epub 2018 Mar 23. |