Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars
ConditionEndodontically Treated Teeth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorHospital San Jose
About this trial
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:
* Do 3D-printed composite resin partial-coverage restorations show similar clinical performance compared with CAD/CAM-milled composite resin restorations? * Are there differences in survival, success rates, and complications between the two types of restorations over a 3-year follow-up period?
Researchers will compare CAD/CAM-milled composite resin restorations with 3D-printed composite resin restorations to evaluate their clinical performance.
Participants will:
* Receive a partial-coverage restoration (onlay or overlay) in an endodontically treated molar. * Be randomly assigned to receive either a CAD/CAM-milled or a 3D-printed composite resin restoration. * Attend follow-up visits at 12, 24, and 36 months. * Undergo clinical evaluations by two blinded evaluators using the revised FDI criteria and standardized photographic documentation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 70 years
Absence of active periodontal disease
Good oral hygiene (O'Leary plaque index <20%)
Absence of parafunctional habits (e.g., bruxism, onychophagia)
Disqualifiers
Untreated active periodontal disease
Poor oral hygiene (O'Leary plaque index ≥20%)
Generalized active caries
Active parafunctional habits
Trial design
Design model
Parallel
Treatments tested in this trial
Milled Composite Resin Onlay/Overlay Restoration
DeviceIndirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars.
3D-Printed Composite Resin Onlay/Overlay Restoration
DeviceIndirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars.
Treatment groups
142 Participants
are divided into 2 treatment groupsGroup A: Milled Composite Resin Onlay/OverlayActive comparator 1 intervention
Group B: 3D-Printed Composite Resin Onlay/OverlayExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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 months2
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 months3
Restoration failure rate
Proportion of restorations requiring replacement during the 36-month follow-up period.
Time frame
36 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov