[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638379":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":44,"locations":49,"responsibleParty":65,"collaborators":31,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":31,"eligibilityCriteria":75,"healthyVolunteers":76,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":31,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":98,"whyStopped":31,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Qassim University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Glass Ionomer Cement (GIC) Group","ACTIVE_COMPARATOR","Glass Ionomer Cement (GIC) Group: Participants receive a NuSmile® prefabricated zirconia crown cemented with conventional glass ionomer cement (Fuji IX GP Extra, GC America) following a standardized polyacrylic-acid-conditioning protocol.",[13],"Procedure: Cementation with Fuji IX GP Extra Glass Ionomer Cement",{"label":15,"type":16,"description":17,"interventionNames":18},"Bioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group","EXPERIMENTAL","Bioactive Resin-Modified Glass Ionomer Cement (BioCem™) Group: Participants receive an identical NuSmile® prefabricated zirconia crown cemented with BioCem™ Universal BioActive Cement (NuSmile®, Houston, TX, USA).",[19],"Procedure: Cementation with BioCem™ Universal BioActive Cement",{"label":21,"type":16,"description":22,"interventionNames":23},"Self-Adhesive Resin Cement (SARC) Group","Self-Adhesive Resin Cement (SARC) Group: Participants receive an identical NuSmile® prefabricated zirconia crown cemented with RelyX™ Universal Resin Cement (3M).",[24],"Procedure: Cementation with RelyX™ Universal Resin Cement",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"PROCEDURE","Cementation with Fuji IX GP Extra Glass Ionomer Cement","Cementation with Fuji IX GP Extra Glass Ionomer Cement Hand-mixed conventional glass ionomer luting cement applied per manufacturer protocol; crown seated under finger pressure for 3 minutes; excess removed after initial set.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Cementation with BioCem™ Universal BioActive Cement","Cementation with BioCem™ Universal BioActive Cement Auto-mixed bioactive resin-modified luting cement applied per manufacturer protocol; brief tack-cure to facilitate excess removal followed by full light-curing for 20 seconds per surface.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Cementation with RelyX™ Universal Resin Cement","Cementation with RelyX™ Universal Resin Cement Self-adhesive dual-cure resin luting cement applied per manufacturer protocol; tack-cured for 2-3 seconds for excess removal, followed by full light-curing for 20 seconds per surface.",[21],[41],{"name":42,"affiliation":5,"role":43},"MURAD ALRASHIDI, BDS, MSC","PRINCIPAL_INVESTIGATOR",[45],{"name":42,"role":46,"phone":47,"phoneExt":31,"email":48},"CONTACT","+966 55 302 2773","MU.ALRASHIDI@qu.edu.sa",[50],{"facility":5,"status":31,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Buraidah","Al-Qassim Region","52571","Saudi Arabia","SA",{"type":57,"coordinates":58},"Point",[59,60],43.97497,26.32599,{"lat":60,"lon":59},[63],{"name":64,"role":46,"phone":47,"phoneExt":31,"email":48},"MURAD ALRASHIDI",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Murad Alrashidi","Assistant Professor in Orthodontics and Pediatric Dentistry","100638379","luting-cements-for-prefabricated-zirconia-crown-retention-in-primary-anterior-teeth-in-children-100638379",false,"NCT07611734","Luting Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth in Children","Comparison of Self-Adhesive Resin, Conventional Glass Ionomer, and Bioactive Resin-Modified Glass Ionomer Cements for Prefabricated Zirconia Crown Retention in Primary Anterior Teeth: A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Healthy children aged 2 to 7 years\n2. One or more primary maxillary or mandibular incisors requiring full-coverage restoration due to caries or trauma\n3. Adequate remaining tooth structure following preparation, defined as greater than 50% of the clinical crown\n4. Parent or legal guardian able and willing to provide written informed consent and to commit to the 36-month follow-up schedule\n\nExclusion Criteria:\n\n1. Active periodontal disease at the index tooth, defined as a Löe Gingival Index score of 2 or higher\n2. Parafunctional habits such as bruxism, severe thumb-sucking, or tongue-thrust documented at screening\n3. Known allergy or hypersensitivity to zirconia, resin, glass ionomer, or any component of the assigned cement\n4. Inconsistent oral hygiene, defined as less than twice-daily toothbrushing per parental report\n5. Systemic disease affecting bone metabolism, tooth development, or wound healing\n6. Current participation in another interventional dental clinical trial",true,"ALL","2 Years","7 Years",{"count":81,"type":82},120,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to compare the long-term clinical performance of three different luting cements used to bond prefabricated zirconia crowns (PZCs) on primary front teeth in young children. The trial will determine whether any single cement offers superior retention, gum health, or marginal sealing compared to the others over a 3-year period.\n\nMain Questions:\n\nThe study aims to answer the following:\n\nAre conventional glass ionomer cement (GIC), bioactive resin-modified glass ionomer cement (BioCem™), and self-adhesive resin cement (SARC) equivalent in retaining prefabricated zirconia crowns on primary incisors over 36 months? Do these cements differ in their effect on gingival health, plaque accumulation, or marginal discoloration around the cemented crown?\n\nComparison:\n\nResearchers will compare three parallel groups of children whose primary incisors are restored with identical prefabricated zirconia crowns but cemented with one of the three different luting cements.\n\nParticipants will: Receive a clinical and radiographic dental examination at screening. Undergo placement of one or more prefabricated zirconia crowns on primary anterior teeth using their randomly assigned cement. Return to the clinic for blinded follow-up evaluations at 12, 24, and 36 months for assessment of crown retention, gingival health, plaque, and marginal staining.",[88,89,90],"Dental Caries","Tooth Injuries","Primary Tooth Restoration",[92,93,94,95,96,97],"Prefabricated Zirconia Crown","Luting Cement","Glass Ionomer Cement","Bioactive Cement","Self-Adhesive Resin Cement","Crown Retention","NOT_YET_RECRUITING","2026-05-21",{"date":101,"type":102},"2026-05-28","ACTUAL",{"date":104,"type":82},"2026-05",{"date":106,"type":82},"2029-07",{"name":67,"class":6},1]