Hospital San José
Santiago, Santiago Metropolitan, Chile
Location status: Recruiting
Location contact
Tomás Yoma Galleguillos, DDS
CONTACT
Tomás Yoma Galleguillos, DDS
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07643311
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.
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Santiago, Santiago Metropolitan, Chile
Location status: Recruiting
Tomás Yoma Galleguillos, DDS
CONTACT
Tomás Yoma Galleguillos, DDS
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Indirect partial coverage restoration fabricated from milled composite resin blocks (HC Block, Shofu, Japan) and adhesively cemented on endodontically treated molars.
Indirect partial coverage restoration fabricated from 3D-printed composite resin (Rodin Sculpture, Pac-Dent, USA) and adhesively cemented on endodontically treated molars.
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.
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.
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.
Time frame: 36 months
Proportion of restorations requiring replacement during the 36-month follow-up period.
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.
Contact information is provided by the study sponsor or research team.
Hospital San Jose
Other
Clinical Performance of CAD/CAM-Milled Versus 3D-Printed Composite Resin Partial-Coverage Restorations for Endodontically Treated Molars: A Randomized Controlled Clinical Trial
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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