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This randomized controlled trial (RCT) compares the 24-month clinical performance of endocrown restorations fabricated by two digital manufacturing pathways: additive manufacturing using 3D-printed ceramic-filled photopolymer resin (VarseoSmile TriniQ, BEGO) versus subtractive computer-aided design/computer-aided manufacturing (CAD/CAM) milling from hybrid nano-ceramic blocks (HC Hard Block, Shofu). Sixty endocrowns will be placed in endodontically treated posterior molars and evaluated using modified United States Public Health Service (USPHS) criteria at 6, 12, and 24 months. The trial is conducted at the Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
Post-endodontic rehabilitation of extensively damaged posterior molars using endocrowns represents a minimally invasive alternative to conventional crown-plus-post-and-core approaches. Digital fabrication has advanced both the precision and reproducibility of endocrown manufacture. While computer-aided design/computer-aided manufacturing (CAD/CAM) milled hybrid ceramic endocrowns are well-validated clinically, prospective clinical data comparing 3D-printed definitive restorations to milled counterparts are absent. This trial employs a parallel-group, 1:1 randomized design with triple blinding of participants, outcome assessors, and statistician. All restorations are delivered using Beautilink SA self-adhesive dual-cure resin cement. The primary outcome is fracture resistance at 24 months; secondary outcomes include retention, marginal adaptation, marginal discoloration, surface texture, anatomic form, color match, secondary caries, fabrication time, and patient satisfaction assessed by Visual Analogue Scale (VAS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAD/CAM Milled Endocrown | Active Comparator | Endocrown restoration fabricated by subtractive CAD/CAM milling from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan), designed using ExoCAD software and milled on a five-axis wet-milling unit. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). |
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| 3D-Printed Endocrown | Experimental | Endocrown restoration fabricated by additive manufacturing using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH & Co. KG, Germany), printed on a 4K LCD printer at 30-45 degree build angle, post-cured under nitrogen atmosphere. Adhesively cemented using Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAD/CAM Milled HC Hard Block Endocrown | Device | Endocrown restoration milled from HC Hard Block hybrid nano-ceramic (Shofu Inc., Japan) using a five-axis wet-milling CAD/CAM unit. Restoration designed with ExoCAD software, finished and glazed per manufacturer protocol, and cemented with Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration Fracture Resistance | Assessed using modified USPHS criteria: Alpha = absence of fracture; Bravo = minor chip amenable to repair; Charlie = catastrophic fracture, unrestorable | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Modified USPHS: Alpha = in situ; Bravo = partial displacement; Charlie = complete loss | 6, 12, and 24 months |
| Marginal Discoloration | Modified USPHS: Alpha = absent; Bravo = superficial; Charlie = penetrating |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina Ez Mohamed, BDS MSc PhD | Contact | 01008007157 | dina.ezz@dentistry.cu.edu.eg | |
| Rawda H Abdelaziz, BDS MSc PhD | Contact | rawda.hesham@dentistry.cu.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Abou-Steit S, Ibrahim SH, Salem M. Three years clinical evaluation of lithium disilicate and hybrid nano-ceramic CAD/CAM endocrowns (randomized clinical trial). Egyptian Dental Journal 2024;70:551-561. |
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| ID | Term |
|---|---|
| D019553 | Tooth, Nonvital |
| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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The treating clinician cannot be blinded due to visible differences between manufacturing workflows. Participants and outcome assessors are blinded to group allocation. The trial statistician is blinded to group assignment throughout analysis.
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| 3D-Printed VarseoSmile TriniQ Endocrown | Device | Endocrown restoration 3D-printed using VarseoSmile TriniQ ceramic-filled photopolymer resin (BEGO GmbH & Co. KG, Germany) on a 4K LCD printer at 30-45 degree build angle. Post-cured under nitrogen atmosphere, surface glazed, and cemented with Beautilink SA self-adhesive dual-cure resin cement (Shofu Inc., Japan). |
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| 6, 12, and 24 months |
| Surface Texture | Modified USPHS: Alpha = smooth; Bravo = minor irregularities; Charlie = extensive breakdown | 6, 12, and 24 months |
| Anatomic Form | Modified USPHS: Alpha = conforms to natural contour; Bravo = discrepancy present, dentin intact; Charlie = dentin or base exposed | 6, 12, and 24 months |
| Color Match | Modified USPHS: Alpha = indistinguishable from adjacent tooth; Bravo = minor deviation, clinically acceptable; Charlie = obvious mismatch; Delta = gross color failure | 6, 12, and 24 months |
| Secondary Caries | Modified USPHS: Alpha = absent; Charlie = present | 6, 12, and 24 months |
| Fabrication Time | Time in minutes from CAD design completion to restoration readiness for cementation | Periprocedural |
| Patient Satisfaction | Visual Analogue Scale 0-100 mm; 0 = entirely dissatisfied, 100 = entirely satisfied | 6, 12, and 24 months |