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The goal of this clinical trial is to compare the clinical performance of Computer-Aided Design and Computer-Aided Manufacturing (CAD/CAM)-milled and 3D-printed composite resin partial-coverage restorations in endodontically treated molars.
The main questions it aims to answer are:
Researchers will compare CAD/CAM-milled composite resin restorations with 3D-printed composite resin restorations to evaluate their clinical performance.
Participants will:
This randomized controlled clinical trial evaluates the clinical performance of indirect composite resin partial-coverage restorations fabricated using subtractive and additive manufacturing technologies in endodontically treated molars.
The study investigates whether 3D-printed composite resin restorations can achieve clinical outcomes comparable to CAD/CAM-milled composite resin restorations when used for cuspal coverage of structurally compromised posterior teeth.
All restorations will be fabricated using a fully digital workflow. Tooth preparation, immediate dentin sealing, digital intraoral scanning, restoration fabrication, and adhesive cementation procedures will be standardized and performed according to a predefined clinical protocol.
The trial will be conducted at Hospital San José, Santiago, Chile, using commercially available restorative materials manufactured by subtractive and additive technologies. Clinical performance will be evaluated according to internationally accepted restorative assessment criteria.
The study aims to generate medium-term clinical evidence regarding the use of 3D-printed composite resin restorations as a potential alternative to conventional CAD/CAM-milled restorations in restorative dentistry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milled Composite Resin Onlay/Overlay | Active Comparator | Participants receive indirect onlay or overlay restorations fabricated from milled composite resin blocks (HC Block, Shofu, Japan) for the rehabilitation of endodontically treated molars with extensive loss of tooth structure. Tooth preparation, immediate dentin sealing, digital impression, and adhesive cementation procedures are standardized for all participants |
|
| 3D-Printed Composite Resin Onlay/Overlay | Experimental | Participants receive indirect onlay or overlay restorations fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) for the rehabilitation of endodontically treated molars with extensive loss of tooth structure. Tooth preparation, immediate dentin sealing, digital impression, and adhesive cementation procedures are standardized for all participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Milled Composite Resin Onlay/Overlay Restoration | Device | Indirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria. | Clinical performance of milled and 3D-printed composite resin onlay and overlay restorations assessed using the revised FDI criteria. An overall FDI evaluation score will be assigned to each restoration by two blinded evaluators. | Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Restoration survival rate | Survival of milled and 3D-printed composite resin onlay and overlay restorations. A restoration will be considered surviving if it remains in function at follow-up, regardless of the need for minor repair. | 36 months |
| Restoration success rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tomás Yoma Galleguillos, DDS | Contact | +56985768407 | tomasyoma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Tomás Yoma Galleguillos, DDS | Hospital San José, Santiago, Chile | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital San José | Recruiting | Santiago | Santiago Metropolitan | Chile |
Individual participant data will not be shared with other researchers due to confidentiality and privacy considerations related to patient information.
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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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Randomized, parallel-group, double-blind clinical trial comparing the clinical performance of milled composite resin versus 3D-printed composite resin onlay and overlay restorations in endodontically treated molars. Participants are allocated in a 1:1 ratio using stratified block randomization.
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Participants and outcome assessors are blinded to treatment allocation. Two independent calibrated evaluators assess the restorations during follow-up visits. The treating clinician is not blinded because of the nature of the interventions. Allocation concealment is maintained through stratified block randomization using sequentially numbered opaque sealed envelopes.
| 3D-Printed Composite Resin Onlay/Overlay Restoration | Device | Indirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars. |
|
Success of restorations according to revised FDI criteria. Restorations receiving clinically acceptable ratings and not requiring corrective intervention will be considered successful. |
| 36 months |
| Restoration failure rate | Proportion of restorations requiring replacement during the 36-month follow-up period. | 36 months |
| Clinical complications | Frequency and type of clinical complications observed during the 36-month follow-up period, including mechanical, biological, and esthetic complications associated with the restorations. | Baseline to 36 months |