Endodontically Treated TeethNCT07643311
Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars
A study testing Milled Composite Resin Onlay/Overlay Restoration and 3D-Printed Composite Resin Onlay/Overlay Restoration in people with Endodontically Treated Teeth, run by Hospital San Jose at 1 site in Chile.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Endodontically Treated Teeth
- What is being tested?
- Milled Composite Resin Onlay/Overlay Restoration and 3D-Printed Composite Resin Onlay/Overlay Restoration
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteChile
- Study dates
- 29 May 2026to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Chile1 site, 1 recruiting
- Recruiting
Hospital San José
Santiago, Santiago Metropolitan
Tomás Yoma Galleguillos, DDS, +56985768407, tomasyoma@gmail.com
Tomás Yoma Galleguillos, DDS
About this study
Official title: 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:
Read more
- 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.
Read the 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.
- Conditions
- Endodontically Treated Teeth
- Being tested
- Milled Composite Resin Onlay/Overlay Restoration, 3D-Printed Composite Resin Onlay/Overlay Restoration
- Keywords
- Onlay, Overlay, Milled Composite Resin, 3D-Printed Composite Resin, partial coverage restoration, CAD/CAM, 3D printing, Indirect restoration, FDI Criteria
- Medical subject headings
- Tooth, Nonvital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: 3D-Printed Composite Resin Onlay/Overlay Restoration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 36 months
Restoration failure rate
Proportion of restorations requiring replacement during the 36-month follow-up period.
Measured: 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.
Measured: Baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study start29 May 2026
- Primary completion31 May 2030 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontically Treated TeethStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital San Jose
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomás Yoma Galleguillos, Hospital San Jose
- Investigators
- Tomás Yoma Galleguillos, DDS, Principal investigator, Hospital San José, Santiago, Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07643311
- Sponsor's protocol ID
- HSJ-RCT-3DPRINT-001
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers due to confidentiality and privacy considerations related to patient information.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of CAD/CAM-Milled Versus 3D-Printed Composite Resin Partial-Coverage Restorations for Endodontically Treated Molars: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07643311
- Acronym / sponsor ID
- HSJ-RCT-3DPRINT-001
- Conditions
- Endodontically Treated Teeth
- Keywords
- Onlay, Overlay, Milled Composite Resin, 3D-Printed Composite Resin, partial coverage restoration, CAD/CAM, 3D printing, Indirect restoration
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Hospital San JoseUniversity, hospital or other
- Study start
- 29 May 2026 (actual)
- Primary completion
- 31 May 2030 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 11 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Milled Composite Resin Onlay/Overlay | Active comparator | Device: Milled Composite Resin Onlay/Overlay RestorationParticipants 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 |
| 3D-Printed Composite Resin Onlay/Overlay | Experimental | Device: 3D-Printed Composite Resin Onlay/Overlay RestorationParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Milled Composite Resin Onlay/Overlay RestorationIndirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars. | Device | Milled Composite Resin Onlay/Overlay |
| 3D-Printed Composite Resin Onlay/Overlay RestorationIndirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars. | Device | 3D-Printed Composite Resin Onlay/Overlay |
Primary outcome
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.
4 secondary outcomes
Restoration survival rate
Time frame: 36 months
Restoration success rate
Time frame: 36 months
Restoration failure rate
Time frame: 36 months
Clinical complications
Time frame: Baseline to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers due to confidentiality and privacy considerations related to patient information.
Related trials for Endodontically Treated Teeth
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Clinical Comparison of Lithium Disilicate and 3D-Printed Resin Endocrowns
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Conservative Versus Conventional Restorative Approach for Endodontically Treated Posterior Teeth
Root Canal Treated Posterior Teeth, Endodontically-Treated Teeth
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Predictable Method for Restoring Endodontically Treated Teeth, Comparing Indirect and Direct Methods and Materials in Aesthetic Dentistry.
Endodontically Treated Teeth Requiring Indirect Restorative Treatment
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Effect of Photobiomodulation on Pain and Healing of the Vertical Releasing Incision After Endodontic Microsurgery
Apical Periodontitis, Endodontically Treated Teeth
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An In-vivo Survival Rate of Different Onlay Materials Placed Over Endodontically Treated Molar Teeth
Dental Restoration Failures
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tomás Yoma Galleguillos, DDS principal investigator
Hospital San José, Santiago, Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Milled Composite Resin Onlay/Overlay Restoration and 3D-Printed Composite Resin Onlay/Overlay Restoration in people with Endodontically Treated Teeth, run by Hospital San Jose at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tomás Yoma Galleguillos, DDS (+56985768407, tomasyoma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.