Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars (NCT07643311) | Clinical Trial Compass
RecruitingNot Applicable
Milled vs 3D-Printed Partial-Coverage Restorations in Endodontically Treated Molars
Chile142 participantsStarted 2026-05-29
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical performance of onlay and overlay restorations according to revised World Dental Federation (FDI) criteria.
Timeframe: Baseline, 12 months, 24 months, and 36 months (primary endpoint at 36 months)