NCT07643311

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for not_applicable

Timeline
49mo left

Started May 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
May 2026Jun 2030

Study Start

First participant enrolled

May 29, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 2, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2030

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2030

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

4 years

First QC Date

June 2, 2026

Last Update Submit

June 9, 2026

Conditions

Endodontically Treated Teeth

Keywords

OnlayOverlayMilled Composite Resin3D-Printed Composite Resinpartial coverage restorationCAD/CAM3D printingIndirect restorationFDI Criteria

Outcome Measures

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.

    Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)

Secondary Outcomes (4)

  • Restoration survival rate

    36 months

  • Restoration success rate

    36 months

  • Restoration failure rate

    36 months

  • Clinical complications

    Baseline to 36 months

Study Arms (2)

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

Device: Milled Composite Resin Onlay/Overlay Restoration

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.

Device: 3D-Printed Composite Resin Onlay/Overlay Restoration

Interventions

Milled Composite Resin Onlay/Overlay RestorationDEVICE

Indirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars.

Milled Composite Resin Onlay/Overlay
3D-Printed Composite Resin Onlay/Overlay RestorationDEVICE

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

3D-Printed Composite Resin Onlay/Overlay

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital San José

Santiago, Santiago Metropolitan, Chile

RECRUITING

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Study Officials

  • Tomás Yoma Galleguillos, DDS

    Hospital San José, Santiago, Chile

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tomás Yoma Galleguillos, DDS

CONTACT

+56985768407tomasyoma@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Dentistry, Hospital San Jose

Study Record Dates

First Submitted

June 2, 2026

First Posted

June 11, 2026

Study Start

May 29, 2026

Primary Completion (Estimated)

May 31, 2030

Study Completion (Estimated)

June 30, 2030

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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

Locations

CL(1)