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This study aims to compare the clinical performance of Prefabricated Zirconia Crowns (PZCs) with that of Custom-made Zirconia Crowns (CZCs) using enhanced clinical protocols.
Young permanent molars presenting with gross caries, pulpal treatment or developmental defects often require full coverage restorations. Recently, the Prefabricated Zirconia Crowns (PZCs) have been introduced as a biocompatible and an aesthetically pleasant option with promising outcomes. However, it comes in specific sizes, limited shades and a significant tooth preparation is often required. Custom-made zirconia crowns (CZCs), fabricated using CAD/CAM technology may; offer a favorable aesthetic alternative by ensuring a controlled tooth reduction, precise fit, better aesthetics, and improved retention. Nevertheless, the current evidence concerning its use in young permanent molars remains limited. This study will be a randomised clinical trial that aims to compare the clinical performance of (PZCs) with that of (CZCs) for the restoration of badly carious/destructed young permanent molars in children aged 7-13. Patients will be randomised into two treatment groups using an online block randomisation technique (block size of 6) and sealed-envelope techniques. Clinical parameters: retention, fracture, gingival health and marginal integrity will be evaluated at 3-month, 6-month, and 12-month intervals. In addition, treatment duration, intraoperative patient comfort and immediate postoperative patient satisfaction will be evaluated and compared. The findings of this study are expected to provide evidence on the suitability of CZC for young permanent molars in children. The Null hypothesis is that there is no difference between the two types of crowns in terms of clinical performance and child acceptance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prefabricated Zirconia Crowns | Experimental | Tooth preparation and cementation of a suitable size of prefabricated Zirconia crown. |
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| Custom-made Zirconia Crowns | Experimental | Tooth preparation, followed by oral scanning and production and cementation of a zirconia crown using CAD-CAM technology. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prefabricated Zirconia Crown | Procedure | Tooth preparation as per the manufacturer's instructions and cementation of a suitable size of prefabricated Zirconia crown using self-adhesive resin cement. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Crown retention | Visual-tactile evaluation of the crown retention over time (crown present, loose or lost). | 3,6 and 12 months |
| Rate of chipping and fracture of the crown | Clinical evaluation for the presence/absence of crown chipping or fracture | 3,6 and 12 months |
| Gingival health | Clinical evaluation of the gingival inflammation ( the gingival index (GI) by Löe & Silness 1963 ) | 3,6 and 12 months |
| Clinical crown margin extension | Visual-tactile evaluation for crown margin extension (supra/ equi/sub-- gingival) | 3,6 and 12 months |
| Radiographic crown margin adaptation | Evaluation of crown margin adaptation (Geduk et al., 2023) | 6 and 12 months |
| Clinical crown margin adaptation | Clinical evaluation of crown margin using an explorer (Geduk et al., 2023) | 3,6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time taken for intervention | Total time taken to perform the intervention for each crown (crown preparation, try-in and cementation) in minutes. | Perioperative/Periprocedural: from the beginning of tooth preparation and until the crown is cemented. |
| Patient satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jordan University of Science and Technology | Irbid | Jordan |
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| Custom-made Zirconia Crowns | Procedure | Tooth preparation (1-1.5 mm occlusal, 0.5 to 1.25 mm circumferential, with a shoulder-edge supra-gingival margin), followed by scanning with an intra-oral scanner, then temporisation. A zirconia crown will be produced using CAD-CAM technology and cemented with a self-adhesive resin cement on a different visit. |
|
Self-reported child acceptance using a 5-points visual analogue scale |
| immediately following intervention. |
| Patient's comfort | will be evaluated by an observer (research assistant who will be trained, and calibrated) and recorded using the Sound, Eyes, and motor scale (SEM); Based on the intensity of the child's discomfort, each parameter is scored into one of four categories (comfort (score 0), mild discomfort (score 1), moderately painful (score 2), and painful (score 3)). The total score can range from 0 to 9, with 9 indicating the highest level of discomfort. | peri-operatively |