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

June 9, 2026 updated by: Tomás Yoma Galleguillos, Hospital San Jose

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Chile
    • Santiago Metropolitan
      • Santiago, Santiago Metropolitan, Chile
        • Recruiting
        • Hospital San José
        • Contact:
        • Principal Investigator:
          • Tomás Yoma Galleguillos, DDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Milled Composite Resin Onlay/Overlay
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
Indirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars.
Experimental: 3D-Printed Composite Resin Onlay/Overlay
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 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria.
Time Frame: Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Restoration survival rate
Time Frame: 36 months
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
Time Frame: 36 months
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
Time Frame: 36 months
Proportion of restorations requiring replacement during the 36-month follow-up period.
36 months
Clinical complications
Time Frame: Baseline to 36 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital San Jose

Investigators

  • Principal Investigator: Tomás Yoma Galleguillos, DDS, Hospital San José, Santiago, Chile

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

June 30, 2030

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 9, 2026

First Posted (Actual)

June 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSJ-RCT-3DPRINT-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers due to confidentiality and privacy considerations related to patient information.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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