[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655178":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":33,"studyPopulation":26,"armGroups":34,"interventions":47,"overallOfficials":61,"centralContacts":65,"locations":26,"responsibleParty":75,"collaborators":26,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":26,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":26,"enrollmentInfo":88,"targetDuration":26,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":104,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":26},{"fullName":5,"class":6},"University of Valencia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Restoration Survival Rate According to Modified USPHS\u002FFDI Criteria","Survival of the restoration, evaluated using the modified United States Public Health Service (USPHS)\u002FFDI criteria (Hickel et al. 2023), assessed by a calibrated, blinded outcomes assessor. Failure is defined as the need for restoration replacement due to fracture, debonding, secondary caries, or unacceptable marginal\u002Fanatomical scores. Analysis will be stratified by pulp status (vital vs. endodontically treated) and compared between the additive and subtractive manufacturing arms.","6, 12, 18, and 24 months",[14],{"measure":15,"description":16,"timeFrame":17},"Volumetric Wear of the Restoration","Volumetric wear measured by superimposition of STL files (intraoral scans) using Geomagic Wrap software, comparing additive and subtractive manufacturing arms.","BASELINE, 6, 12, 18, and 24 months",[19],{"measure":20,"description":21,"timeFrame":22},"Color Stability","Color change assessed by CIELAB parameters (Lab\\*), measured with the OptiShade digital colorimeter (STYLEItaliano) under standardized capture conditions","Baseline, 3, 6, 12, 18, and 24 months",{"allocation":24,"interventionModel":25,"interventionModelDescription":26,"primaryPurpose":27,"observationalModel":26,"timePerspective":26,"maskingInfo":28},"RANDOMIZED","PARALLEL",null,"TREATMENT",{"masking":29,"maskingDescription":26,"whoMasked":30},"DOUBLE",[31,32],"PARTICIPANT","OUTCOMES_ASSESSOR","This is a prospective, randomized, parallel-group, double-blind (participant and outcomes assessor) interventional clinical trial conducted at the Dental Clinic of the University of Valencia. Eligible restorations will be randomly allocated, in permuted blocks of variable size (4 and 6), stratified by pulp status (vital and endodontically treated tooth), using a sequence generated independently for each stratum by a Python-based algorithm.\n\nRestorations will be assigned to one of two manufacturing techniques: additive manufacturing, using a 3D-printed resin composite (Crowntec, Saremco Dental AG), or subtractive manufacturing, using a CAD\u002FCAM-milled resin composite block (Brilliant Crios, Coltene). Both materials share a comparable base composition (Bis-EMA methacrylate matrix with barium glass and silica filler), so that the primary variable under study is the manufacturing method rather than the material composition.\n\nAll restorations will follow a standardized clinical protocol comprising tooth preparation, immediate dentin sealing (for vital teeth), intraoral digital scanning, computer-aided design, manufacture by the assigned technique, standardized surface treatment, and adhesive cementation. Provisional restorations will be placed between the preparation and cementation visits.\n\nClinical follow-up assessments will be conducted at baseline (1 week after cementation) and at 3, 6, 12, 18, 24, 30, and 36 months, and will include clinical evaluation using the revised FDI World Dental Federation criteria (Hickel et al., 2023), standardized calibrated color photography, and intraoral scanning for volumetric wear analysis by superimposition of successive scans onto the baseline scan using reverse-engineering software.\n\nParticipants and outcomes assessors will remain blinded to the type of restoration received; the treating clinician cannot be blinded due to the nature of the manufacturing process. Calibration sessions will be conducted among all evaluators to ensure consistency in outcome assessment. An independent statistician, blinded to group allocation, will perform the statistical analysis.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Additive Manufacturing (3D-Printed Resin Onlay\u002FOverlay)","EXPERIMENTAL","Posterior partial indirect restoration (onlay\u002Foverlay) fabricated by additive manufacturing using saremco print CrownTec®, designed from a digital intraoral scan and printed on an AccuFab-L4D 3D printer.",[40],"Device: 3D-Printed Resin Onlay\u002FOverlay (saremco print CrownTec®)",{"label":42,"type":43,"description":44,"interventionNames":45},"Subtractive Manufacturing (Milled Resin Onlay\u002FOverlay)","ACTIVE_COMPARATOR","Posterior partial indirect restoration (onlay\u002Foverlay) fabricated by subtractive manufacturing (milling) from Brilliant Crios CAD\u002FCAM blocks, designed from the same digital intraoral scan protocol used in the experimental arm.",[46],"Device: Milled Resin Onlay\u002FOverlay (Brilliant Crios)",[48,55],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"DEVICE","3D-Printed Resin Onlay\u002FOverlay (saremco print CrownTec®)","Onlay\u002Foverlay restorations will be fabricated using a printable resin for permanent restorations (saremco print CrownTec®). Digital intraoral scans will be used for design. Restorations will be placed in vital and endodontically treated posterior teeth and evaluated at baseline, 3, 6, 12, 18, and 24 months according to FDI criteria.",[36],[54],"Additive Manufacturing; saremco print CrownTec",{"type":49,"name":56,"description":57,"armGroupLabels":58,"otherNames":59},"Milled Resin Onlay\u002FOverlay (Brilliant Crios)","Onlay\u002Foverlay restorations will be fabricated using a milling unit and a Bis-EMA-based dispersed-filler CAD\u002FCAM composite block (Brilliant Crios). Digital intraoral scans will be used for design. Restorations will be placed in vital and endodontically treated posterior teeth and evaluated at baseline, 3, 6, 12, 18, and 24 months according to FDI criteria.",[42],[60],"Subtractive Manufacturing; Brilliant Crios",[62],{"name":63,"affiliation":5,"role":64},"JORGE ALONSO PEREZ-BARQUERO, PROFESSOR","STUDY_CHAIR",[66,71],{"name":67,"role":68,"phone":69,"phoneExt":26,"email":70},"LUCIA FERNANDEZ-ESTEVAN, PROFESSOR","CONTACT","659560097","lucia.fernandez-estevan@uv.es",{"name":72,"role":68,"phone":73,"phoneExt":26,"email":74},"ALEXANDRA FLESARIU ONU, DOCTORAL STUDENT","642083465","flesariu@alumni.uv.es",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Lucía Fernández de Estevan","PROFESSOR","100655178","3d-printed-versus-cadcam-milled-resin-restorations-in-posterior-teeth-100655178",false,"NCT07811167","3D-Printed Versus CAD\u002FCAM-Milled Resin Restorations in Posterior Teeth.","Clinical Performance of 3D-Printed Versus CAD\u002FCAM-Milled Resin Restorations: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* • Adult patients (≥18 years) attending the University Dental Clinic (Universitat de València) in need of a posterior indirect partial restoration (onlay\u002Foverlay)\n\n  * Permanent posterior tooth (premolar or molar) presenting extensive coronal destruction (caries, fracture, or failed previous restoration) requiring indirect restoration, with at least one weakened or missing cusp\n  * Sufficient remaining tooth structure to allow adequate adhesive isolation (rubber dam) and adhesive cementation\n  * Tooth classified as either vital (Stratum 1) or endodontically treated with an adequate, asymptomatic root canal filling and no radiographic signs of periapical pathology (Stratum 2)\n  * Natural antagonist dentition\n  * Favorable occlusal relationship\n  * Healthy periodontal status or adequately controlled periodontal disease (probing depth ≤ 3 mm, no active clinical attachment loss)\n  * Willingness and ability to attend all scheduled follow-up visits over the 24-month study period\n  * Signed informed consent\n\nExclusion Criteria:\n\n* • Known allergy or hypersensitivity to methacrylate-based materials, Bis-EMA, or any component of the restorative materials used (per manufacturer contraindications for saremco print CrownTec® and Brilliant Crios)\n\n  * Parafunctional habits (bruxism, clenching, or foreign object chewing) without adequate occlusal protection\n  * Active or untreated periodontal disease\n  * Poor oral hygiene or inability to maintain adequate plaque control\n  * Temporomandibular joint disorders\n  * Tooth requiring full-coverage restoration (crown) rather than a partial indirect restoration\n  * Endodontically treated tooth with inadequate root canal filling, periapical pathology, or insufficient remaining coronal structure to support the restoration without additional foundation (e.g., post\u002Fcore) beyond the study protocol\n  * Pregnant or breastfeeding patients\n  * Uncontrolled systemic disease that could compromise treatment outcome or follow-up compliance\n  * Active substance abuse\n  * Participation in another interventional clinical trial that could interfere with study outcomes\n  * Inability to provide informed consent","ALL","18 Years",{"count":89,"type":90},70,"ESTIMATED","INTERVENTIONAL",[93],"NA","Indirect resin restorations had become a well-established conservative alternative to direct composite restorations in posterior teeth, particularly in cases of significant loss of tooth structure requiring cuspal coverage (onlays\u002Foverlays). Compared with direct restorations, indirect techniques reduced the impact of polymerization shrinkage and shrinkage stress, generally achieving a higher degree of monomer conversion and greater resistance to marginal microleakage and wear, although at the cost of more extensive tooth preparation.\n\nWith the advancement of digital dentistry, indirect resin restorations could be fabricated using either subtractive manufacturing (CAD\u002FCAM milling of prefabricated resin blocks) or, more recently, additive manufacturing (3D printing). Improvements in ceramic-filled resin formulations and in printing and post-processing protocols had expanded 3D printing from provisional to definitive restorations. Among printable materials, Crowntec (Saremco Dental AG) had demonstrated the most favorable mechanical properties reported in the literature, exceeding the minimum flexural strength threshold established by ISO 6872:2024 for monolithic single-unit restorations, although generally remaining below the values achieved by milled CAD\u002FCAM resin blocks.\n\nDespite the increasing clinical use of 3D-printed resins, evidence on their long-term clinical performance remained scarce, particularly in comparison with CAD\u002FCAM-milled restorations. Existing data were derived mainly from in vitro studies with heterogeneous methodologies, limiting their extrapolation to real clinical conditions, where biological aging, occlusal loading, and patient-specific factors play a determining role.\n\nAim of the Study\n\nThe study aimed to evaluate and compare the following:\n\n* The clinical performance of posterior indirect resin restorations fabricated by 3D printing (Crowntec, Saremco Dental AG) versus CAD\u002FCAM milling (Brilliant Crios, Coltene), over a follow-up period of 36 months.\n* The volumetric wear of the restoration and of the antagonist tooth according to the manufacturing technique.\n* The effect of pulp status (vital vs. endodontically treated tooth) on the success and survival of the restorations.\n\nStudy Summary A prospective, randomized, parallel-group, double-blind (participant and outcomes assessor) clinical trial is being conducted at the Clínica Odontológica of the Universitat de València (Fundación Lluís Alcanyís). Each patient provides informed consent prior to participation, and ethical approval has been obtained from the Comité Ético de Investigación en Humanos of the Universitat de València.\n\nAdult patients (≥18 years, ASA I or II) requiring a posterior indirect restoration with cuspal coverage, in either vital or endodontically treated teeth, are eligible for inclusion. Restorations are randomly assigned, in permuted blocks stratified by pulp status, to be fabricated by additive manufacturing (3D-printed resin) or subtractive manufacturing (CAD\u002FCAM-milled resin).\n\nStandardized tooth preparations are performed under local anesthesia using cuspal-coverage preparation principles, including immediate dentin sealing for vital teeth. Intraoral digital impressions are taken, and provisional restorations are placed. Final restorations are fabricated using either 3D printing or CAD\u002FCAM milling techniques, depending on group assignment, and are cemented using resin cement following manufacturer instructions under rubber dam isolation.\n\nClinical evaluation is performed by a blinded outcomes assessor at baseline (1 week) and at 3, 6, 12, 18, 24, 30, and 36 months, using the revised FDI World Dental Federation criteria (Hickel et al., 2023), assessing functional, esthetic, and biological properties. Volumetric wear of the restoration and of the antagonist tooth is quantified by superimposition of successive intraoral digital scans, and restoration color change is assessed by standardized calibrated photography. An independent, blinded statistician performs the statistical analysis.",[96],"Dental Restorations Longevity",[98,99,100,101,102,103],"Subtractive manufacturing","Additive manufacturing","Overlay","Posterior indirect restorations","Restoration survival","Randomized controlled trial","NOT_YET_RECRUITING","2026-09-02",{"date":107,"type":108},"2026-09-09","ACTUAL",{"date":110,"type":90},"2026-10-01",{"date":112,"type":90},"2028-12-31",{"name":5,"class":6}]