An interventional study of Milled Composite Resin Onlay/Overlay Restoration and 3D-Printed Composite Resin Onlay/Overlay Restoration in Endodontically Treated Teeth, sponsored by Hospital San Jose. Recruiting at 1 site in Chile. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Hospital San Jose · Not applicable, Interventional, and Treatment
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.
111 studies on the registry are indexed under Tooth, Nonvital; 18 are open to participants now.
This study's planned enrollment of 142 is above the median of 50 across 101 interventional studies indexed under Tooth, Nonvital.
Browse Tooth, Nonvital studies →This is the only study on the registry with Hospital San Jose as lead sponsor.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Device: Milled Composite Resin Onlay/Overlay Restoration
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.
Device: 3D-Printed Composite Resin Onlay/Overlay Restoration
Indirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars.
Indirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars.
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.
Time frame: Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)
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.
Time frame: 36 months
Restoration success rate
Success of restorations according to revised FDI criteria. Restorations receiving clinically acceptable ratings and not requiring corrective intervention will be considered successful.
Time frame: 36 months
Restoration failure rate
Proportion of restorations requiring replacement during the 36-month follow-up period.
Time frame: 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.
Time frame: Baseline to 36 months
Plan to share: No — Individual participant data will not be shared with other researchers due to confidentiality and privacy considerations related to patient information.
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