[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"restoration-defects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:restoration-defects":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":5},"100655547","repair-versus-replacement-of-failed-restorations-in-primary-teeth-100655547",false,"NCT07813065","Repair Versus Replacement of Failed Restorations in Primary Teeth","Repair Versus Replacement of Failed Restorations in Primary Teeth: Protocol for a Non-Inferiority Randomized Clinical Trial","Inclusion Criteria:\n\n* Children aged 4 to 8 years;\n* Presence of at least one defective restoration in a primary molar, involving no more than 3 surfaces;\n* Absence of clinical and radiographic signs of pulp involvement;\n\nExclusion Criteria:\n\n* Tooth without pulp vitality or requiring endodontic treatment;\n* Loose or mobile restoration;\n* Presence of fistula, abscess, or history of pain;\n* Tooth mobility incompatible with the physiological exfoliation timeline;\n* Parents\u002Fguardians who do not consent to participation by signing the ICF, or children who do not assent to participate in the study.","ALL","4 Years","8 Years",{"count":20,"type":21},382,"ESTIMATED","INTERVENTIONAL",[24],"NA","Dental caries affect approximately 573 million children globally, and the management of failed restorations is a frequent clinical issue in pediatric dentistry. Although complete replacement of restorations is traditionally the most commonly adopted approach, repair represents a minimally invasive alternative that preserves healthy dental structure and reduces the risk of pulpal complications. Studies in permanent teeth demonstrate that repair may present longevity similar to replacement; however, there is no robust evidence regarding this comparison in primary teeth. This randomized controlled clinical trial, with parallel groups and a 1:1 allocation ratio, aims to evaluate the non-inferiority of repair compared with replacement of failed restorations in primary molars, using encapsulated high-viscosity glass ionomer cement. Children aged 4 to 8 years with at least one failed restoration eligible for repair in primary molars will be included. Randomization will be stratified by number of surfaces. Teeth (n=824) will be randomly allocated to one of the groups: repair or replacement. The primary outcome will be restoration survival at 24 months. Cost-effectiveness will be evaluated as a secondary outcome. Statistical analysis will use Kaplan-Meier curves and Cox regression with shared frailty (¿=5%).",[27,28,29],"Dental Caries","Restoration Defects","Primary Teeth",[31,32,33,34,35,36],"Tooth, Deciduous","Dental Restoration Failure","Dental Restoration, Permanent","Glass Ionomer Cements;","Child","Randomized Controlled Trial;","NOT_YET_RECRUITING","2026-09-16",{"date":40,"type":41},"2026-09-21","ACTUAL",{"date":43,"type":21},"2026-10-07",{"date":45,"type":21},"2029-04-01",{"name":47,"class":48},"University of Sao Paulo","OTHER"]