[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415769":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":42,"studyPopulation":30,"armGroups":43,"interventions":56,"overallOfficials":30,"centralContacts":61,"locations":67,"responsibleParty":83,"collaborators":30,"id":85,"slug":30,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":88,"acronym":30,"eligibilityCriteria":89,"healthyVolunteers":90,"sex":91,"minAge":30,"maxAge":30,"enrollmentInfo":92,"targetDuration":30,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":105,"overallStatus":70,"whyStopped":30,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Ljubljana, Faculty of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":30},[9],{"measure":10,"description":11,"timeFrame":12},"Survival rate of zirconia RBFDPs","Survival rate is defined by debonding or restoration loss","From baseline through study completion, an average of 1 year",[14,16,18,21,24,27],{"measure":15,"description":15,"timeFrame":12},"Porcelain chipping",{"measure":17,"description":17,"timeFrame":12},"Zirconia framework fracture",{"measure":19,"description":20,"timeFrame":12},"Gingivitis","Visual and tactile inspection of gingiva",{"measure":22,"description":23,"timeFrame":12},"Parodontitis","Gingival sulcus depth measurement",{"measure":25,"description":26,"timeFrame":12},"Marginal leakage","Discoloration of a restoration margin",{"measure":28,"description":29,"timeFrame":12},"Secondary caries","Caries between the tooth and restoration margin",null,{"allocation":32,"interventionModel":33,"interventionModelDescription":34,"primaryPurpose":35,"observationalModel":30,"timePerspective":30,"maskingInfo":36},"RANDOMIZED","PARALLEL","This is a single-centre, prospective, randomized, controlled, double-blind clinical trial.","TREATMENT",{"masking":37,"maskingDescription":38,"whoMasked":39},"DOUBLE","Prior to the beginning of the study 50 identification numbers were divided into 2 groups on the basis of a computer generated tables (www.randomization.com). The two groups were then randomly allocated to the zirconia pretreatment method using a random generator. The randomization process was conducted by a staff member not involved in the research protocol. For each identification number, the selected pretreatment is written on a card contained in an opaque sealed envelope. The envelopes are stored by a study supervisor. Each envelope is opened by a dental technician after the RBFDP's zirconia framework is milled and then once again stored by the study supervisor until the conclusion of a study.",[40,41],"PARTICIPANT","CARE_PROVIDER","Zirconia resin-bonded fixed dental prostheses (RBFDPs) have been regarded as a promising minimally invasive alternative for the replacement of missing central and lateral incisors, offering several advantages to orthodontic space closure or tooth replacement with implant-supported restorations. Debonding of the zirconia RBFDPs represents the main technical complication since clinically established airborne particle abrasion (APA) of an inert zirconia surface does not always provide sufficient resin-bond strength. Further, APA can also impair the mechanical properties of zirconia restoration affecting its long-term success. Nano-structured alumina coating (NAC) presents an alternative non-invasive zirconia surface pretreatment. The aim of this randomized controlled clinical trial is to study the effect of NAC coated bonding surface of zirconia RBFDPs affecting its debonding and clinical survival rate.\n\nThe study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) as a surface pretreatment method of zirconia RBFDPs. Healthy patients in need of a missing central or lateral incisor replacement are screened and rated to be eligible by two calibrated dentists. RBFDPs are randomly allocated into two groups and inserted by the same operator. The first group, where the bonding surface is pretreated with APA serves a control group. In the second group the restorations are pretreated with NAC. The participants and the operator are blinded to the group assignment in a double-blinded trial design. The primary outcome evaluated is the retention\u002Fsurvival of the RBFDP. Non-parametric tests and Kaplan-Meyer analysis will be used to determine differences between both study groups.",[44,50],{"label":45,"type":46,"description":47,"interventionNames":48},"APA","ACTIVE_COMPARATOR","Air-borne particle abrasion of zirconia RBFDPs prior to bonding",[49],"Other: APA",{"label":51,"type":52,"description":53,"interventionNames":54},"NAC","EXPERIMENTAL","Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework",[55],"Other: NAC",[57,59],{"type":6,"name":51,"description":53,"armGroupLabels":58,"otherNames":30},[51],{"type":6,"name":45,"description":47,"armGroupLabels":60,"otherNames":30},[45],[62],{"name":63,"role":64,"phone":65,"phoneExt":30,"email":66},"Tine Malgaj, DMD","CONTACT","+386 31 410140","tine.malgaj@mf.uni-lj.si",[68],{"facility":69,"status":70,"city":71,"state":30,"zip":72,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Medical Faculty - University of Ljubljana Ljubljana","RECRUITING","Ljubljana","1000","Slovenia","SI",{"type":76,"coordinates":77},"Point",[78,79],14.50513,46.05108,{"lat":79,"lon":78},[82],{"name":63,"role":64,"phone":65,"phoneExt":30,"email":66},{"type":84,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100415769",false,"NCT04693949","Effect of Nano-structured Alumina Coating on the Bond Strength of Zirconia Resin-bonded Fixed Dental Prostheses","Inclusion Criteria:\n\n1\\. Patients with missing central or lateral incisor\n\nExclusion Criteria:\n\n1. inadequate edentulous space for the pontic\n2. signs of bruxism\n3. abutment tooth with active periodontal or periapical disease\n4. inadequate enamel bonding surface of the abutment tooth\n5. inadequate interocclusal space for a retainer wing and a proximal connector\n6. pontic guidance\n7. physical or psychological disease likely to interfere with normal conduct of the study",true,"ALL",{"count":93,"type":94},80,"ESTIMATED","INTERVENTIONAL",[97],"NA","The purpose of this study is to evaluate the clinical outcome of resin-bonded fixed dental prostheses (RBFDPs) pretreated with nanostructured alumina coating (NAC).\n\nThe study adopts a prospective, randomized, controlled, double-blind design contrasting the use of NAC to air-borne particle abrasion (APA) (control) as a surface pretreatment method of zirconia RBFDPs used for replacing missing central or lateral incisors. The primary outcome evaluated is the retention\u002Fsurvival of the zirconia RBFDPs pretreated with APA and NAC.",[100,101,102,103,104],"Missing Incisors","Zirconia Surface Pretreatment","Children","Adults","Debonding",[106,107,108],"Airborne particle abrasion","Nanostructured alumina coating","Resin-bonded fixed dental prostheses","2026-06-18",{"date":111,"type":112},"2026-06-23","ACTUAL",{"date":114,"type":112},"2018-01-03",{"date":116,"type":94},"2030-01-01",{"name":5,"class":6},1]