RecruitingNot ApplicableNCT07643311

Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars

Clinical Performance of CAD/CAM-Milled Versus 3D-Printed Composite Resin Partial-Coverage Restorations for Endodontically Treated Molars: A Randomized Controlled Clinical Trial


Sponsor

Hospital San Jose

Enrollment

142 participants

Start Date

May 29, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria9

  • 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)
  • Endodontically treated first molars (maxillary or mandibular) with extensive Class II cavities and loss of at least one cusp, requiring onlay or overlay restoration
  • Tooth with functional occlusal contact and at least one proximal contact
  • Referred from the Endodontics Department of Hospital San José, with endodontic treatment completed at the same institution
  • Ability to provide written informed consent
  • Ability to attend follow-up visits at 12, 24, and 36 months

Exclusion Criteria8

  • Untreated active periodontal disease
  • Poor oral hygiene (O'Leary plaque index ≥20%)
  • Generalized active caries
  • Active parafunctional habits
  • Teeth with complete circumferential structural destruction or insufficient coronal tooth structure for onlay/overlay restoration
  • Subgingival margins compromising the biologic width
  • Known allergy to study materials
  • Pregnancy or breastfeeding

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEMilled 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.

DEVICE3D-Printed Composite Resin Onlay/Overlay Restoration

Indirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars.


Locations(1)

Hospital San José

Santiago, Santiago Metropolitan, Chile

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07643311


Related Trials