[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100618255":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":42,"collaborators":45,"id":49,"slug":20,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":20,"eligibilityCriteria":54,"healthyVolunteers":50,"sex":55,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":20,"studyType":61,"phases":62,"briefSummary":64,"conditions":65,"keywords":72,"overallStatus":79,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Universitat Internacional de Catalunya","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Graphene-Reinforced CAD\u002FCAM Indirect Restoration","EXPERIMENTAL","Minimally invasive preparation, composite base build-up when indicated, adhesive protocol with total-etch technique, CAD\u002FCAM fabrication using graphene-reinforced polymer (G-CAM®), adhesive cementation under rubber dam isolation, finishing and polishing, and follow-up at 1 week, 3, 6, and 12 months.",[13],"Device: Graphene-reinforced CAD\u002FCAM polymer (G-CAM®)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Graphene-reinforced CAD\u002FCAM polymer (G-CAM®)","Graphene-reinforced CAD\u002FCAM polymer (G-CAM®) used for the fabrication of indirect inlay, onlay, or overlay restorations in permanent molars affected by molar-incisor hypomineralization (MIH). Restorations are fabricated using a digital CAD\u002FCAM workflow and adhesively cemented under rubber dam isolation according to the study protocol.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Luis Carlos Garza Garza","CONTACT","+34938732017","luiscarlos@UIC.es",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Dental Esthetic BCN","Sarrià-Sant Gervasi","Barcelona","08034","Spain",{"type":35,"coordinates":36},"Point",[37,38],2.1394,41.40104,{"lat":38,"lon":37},[41],{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":43,"investigatorFullName":23,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"PRINCIPAL_INVESTIGATOR","Restorative and Prosthodontics MSc.",[46],{"name":47,"class":48},"Clínica Odontologica de la Universidad de Barcelona ( UB)","UNKNOWN","100618255",false,"NCT07329244","Graphene-Reinforced CAD\u002FCAM Restorations for MIH-Affected Molars in Adolescents: A Prospective Clinical Study","Clinical Evaluation of Graphene-Reinforced CAD\u002FCAM Indirect Restorations in Molars Affected by Molar-Incisor Hypomineralization (MIH) in Adolescents: A Clinical Study","Inclusion Criteria:\n\n* Adolescents aged 10-16 years.\n* Permanent molars with moderate or severe MIH (EAPD criteria).\n* Vital and restorable teeth.\n* Ability to attend follow-up visits.\n* Informed consent from guardian + assent from the minor.\n\nExclusion Criteria:\n\n* Fluorosis, amelogenesis imperfecta, or other enamel defects.\n* Severe bruxism not controlled.\n* Active extensive caries or irreversible pulpitis.\n* Systemic conditions affecting enamel or healing.\n* Hypersensitivity\u002Fallergy to materials\u002Fadhesives.\n* Use of analgesics\u002FAINEs \\\u003C24 h before baseline VAS.\n\n  * Orthodontic bands on the study molar.","ALL","10 Years","16 Years",{"count":59,"type":60},30,"ESTIMATED","INTERVENTIONAL",[63],"NA","This study evaluates the clinical performance, marginal integrity, surface wear, color stability, and postoperative sensitivity of graphene-reinforced CAD\u002FCAM indirect restorations (inlays, onlays, overlays) in molars affected by moderate to severe Molar-Incisor Hypomineralization (MIH) in adolescents. A total of 30 patients aged 10-16 years will receive minimally invasive indirect restorations fabricated from a nano-reinforced graphene polymer (G-CAM®). Clinical outcomes will be assessed using FDI criteria, VAS sensitivity scores, patient satisfaction, and digital 3D scans over a 12-month follow-up. The study aims to determine clinical acceptability and safety compared with historical outcomes reported for composite and lithium-disilicate indirect restorations.",[66,67,68,69,70,71],"Tooth Demineralization","Tooth Sensitivity","Enamel Mineralization Disorders","Tooth Sensitivity After Composite Restorations","Tooth Eruption Disorder","Indirect Restoration",[73,74,75,76,77,78],"molar-incisor hypomineralization","MIH","enamel defects","indirect restorations","minimally invasive dentistry","adhesive dentistry","NOT_YET_RECRUITING","2025-12-28",{"date":82,"type":83},"2026-01-09","ACTUAL",{"date":85,"type":60},"2026-01-10",{"date":87,"type":60},"2027-01-11",{"name":5,"class":6},1]