[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659652":3},{"organization":4,"outcomesModule":7,"designInfo":37,"detailedDescription":46,"studyPopulation":36,"armGroups":47,"interventions":60,"overallOfficials":70,"centralContacts":76,"locations":84,"responsibleParty":100,"collaborators":104,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":36,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":36,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":127,"overallStatus":139,"whyStopped":36,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Çanakkale Onsekiz Mart University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":36},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Success Rate Based on Modified FDI Criteria","The clinical performance of the restorations will be evaluated using the modified World Dental Federation (FDI) criteria, which assess aesthetic, functional, and biological properties on a scale of 1 to 5. Higher scores indicate poorer clinical performance. Each restoration will be classified as either clinically acceptable (FDI scores 1-3) or clinically unacceptable (FDI scores 4-5). The overall clinical success rate will be calculated as the percentage of clinically acceptable restorations.","At 12 months post-operative",[14,18,22,25,29,33],{"measure":15,"description":16,"timeFrame":17},"Long-Term Restoration Survival Rate a","Assessment of overall restoration survival and retention rates over a 36-month period","At 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months",{"measure":19,"description":20,"timeFrame":21},"Restoration Application Time","Recording the total placement time in seconds during the restorative procedure.","Day 1 (during the restorative procedure)",{"measure":23,"description":24,"timeFrame":21},"Clinician Ease of Use","Evaluating the clinician's ease of use using a Visual Analog Scale (VAS) (VAS, range 0 to 100 mm, where higher scores indicate greater ease of use).",{"measure":26,"description":27,"timeFrame":28},"Patient Satisfaction","Evaluation of the child patient's satisfaction regarding the restoration procedure measured using the Smiles Scale. (range 1 to 5, where higher scores indicate better patient satisfaction)","At 7 days post-operative",{"measure":30,"description":31,"timeFrame":32},"Silness-Lõe Plaque Index Score","Assessment of oral hygiene levels using the Silness-Lõe plaque index. (range 0 to 3, where higher scores indicate poorer oral hygiene)","At baseline, 6 months, 12 months, 24 months, and 36 months",{"measure":34,"description":35,"timeFrame":32},"Gingival Index Score","Assessment of gingival health status using the gingival index. (range 0 to 3, where higher scores indicate severe inflammation and poorer gingival health)",null,{"allocation":38,"interventionModel":39,"interventionModelDescription":36,"primaryPurpose":40,"observationalModel":36,"timePerspective":36,"maskingInfo":41},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":42,"maskingDescription":36,"whoMasked":43},"DOUBLE",[44,45],"PARTICIPANT","OUTCOMES_ASSESSOR","This study is designed as a prospective, single-center, double-blind, randomized controlled clinical trial with a split-mouth design. A total of 70 cooperative pediatric patients aged 4 to 9 years having bilateral primary second molars with Class II dentin caries will be enrolled. Randomization will be performed at the patient level using a permuted block randomization method with sealed envelopes to assign treatments to contralateral homologous tooth pairs. Two restorative materials will be evaluated: a chemically-cured bulk-fill flowable composite (Stela Capsule, SDI Limited) applied with Stela Primer, and a light-cured high-viscosity bulk-fill composite (Filtek One Bulk Fill Restorative, 3M Solventum) applied with Scotchbond Universal Adhesive. All restorations will be placed by a single operator following strict isolation and manufacturer instructions. Clinical evaluations will be conducted by two independent, calibrated, and blinded observers at 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months using modified FDI criteria. Secondary parameters, including restoration application time, clinician ease of use (evaluated via Visual Analog Scale), patient satisfaction (measured using the Smiles Scale at 7 days), and oral hygiene indexes (Silness-Loe plaque index and gingival index), will also be recorded. Statistical analyses will include McNemar's test, Kaplan-Meier survival analysis, Generalized Estimating Equations (GEE), and mixed-effects logistic regression models.",[48,54],{"label":49,"type":50,"description":51,"interventionNames":52},"Test Group - Stela Capsule","EXPERIMENTAL","Direct restorative application of a chemically-cured flowable bulk-fill composite material (Stela Capsule) following the application of Stela Primer to the cavity surfaces in primary second molar Class II cavities, set without a light source.",[53],"Device: Stela Capsule Bulk Fill Flowable Self-Cure Restorative",{"label":55,"type":56,"description":57,"interventionNames":58},"Control Group - Filtek One","ACTIVE_COMPARATOR","Direct restorative application of a light-cured high-viscosity bulk-fill composite material (Filtek One Bulk Fill Restorative) following the application of Scotchbond Universal Adhesive, polymerized with an LED light source ($1200\\~mW\u002Fcm\\^{2}$) for 20 seconds.",[59],"Device: Filtek One Bulk Fill Restorative",[61,66],{"type":62,"name":63,"description":64,"armGroupLabels":65,"otherNames":36},"DEVICE","Stela Capsule Bulk Fill Flowable Self-Cure Restorative","Direct restorative application of a chemically-cured flowable bulk-fill composite material following the application of Stela Primer to cavity surfaces in primary second molar Class II cavities",[49],{"type":62,"name":67,"description":68,"armGroupLabels":69,"otherNames":36},"Filtek One Bulk Fill Restorative","Direct restorative application of a light-cured high-viscosity bulk-fill composite material following the application of Scotchbond Universal Adhesive, polymerized with an LED light source for 20 seconds.",[55],[71,74],{"name":72,"affiliation":5,"role":73},"Burak Çarıkçıoğlu","PRINCIPAL_INVESTIGATOR",{"name":75,"affiliation":5,"role":73},"Sıla Erdal",[77,81],{"name":72,"role":78,"phone":79,"phoneExt":36,"email":80},"CONTACT","+905054956091","carikcioglub@gmail.com",{"name":75,"role":78,"phone":82,"phoneExt":36,"email":83},"+905455840010","silaerdal13@gmail.com",[85],{"facility":5,"status":36,"city":86,"state":87,"zip":36,"country":88,"countryCode":36,"cosmosGeoPoint":89,"geoPoint":94,"contacts":95},"Çanakkale","Merkez","Turkey (Türkiye)",{"type":90,"coordinates":91},"Point",[92,93],26.41271,40.15552,{"lat":93,"lon":92},[96,97,98],{"name":72,"role":78,"phone":79,"phoneExt":36,"email":80},{"name":72,"role":73,"phone":36,"phoneExt":36,"email":36},{"name":75,"role":99,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"type":101,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"SPONSOR_INVESTIGATOR","Burak Carıkcıoglu","Associate Professor, Department of Pedodontics",[105],{"name":5,"class":6},"100659652","clinical-evaluation-of-different-bulk-fill-restorative-materials-in-primary-molars-100659652",false,"NCT07868016","Clinical Evaluation of Different Bulk-Fill Restorative Materials in Primary Molars","Evaluation of Clinical Success and Survival of Different Restorative Materials in Primary Teeth: A Randomized Controlled Split-Mouth Clinical Trial","Inclusion Criteria:\n\n* Cooperative pediatric patients aged between 4 and 9 years.\n* Presence of bilateral primary second molars with Class II dentin caries requiring restoration.\n* Teeth with positive response to vitality tests (where applicable) and no clinical signs or symptoms of irreversible pulpitis, periapical pathology, or spontaneous pain.\n* Teeth restorable with direct restorative techniques.\n* Parents or legal guardians providing signed informed consent.\n\nExclusion Criteria:\n\n* Patients with systemic diseases, bleeding disorders, or physical\u002Fmental disabilities that prevent cooperation during dental treatment.\n* Teeth with excessive loss of tooth structure that cannot be restored with a direct restoration or requiring crown coverage.\n* Teeth with clinical or radiographic signs of pulp exposure, pulp involvement, internal\u002Fexternal resorption, or periapical\u002Ffurcation involvement.\n* Teeth with poor oral hygiene or high caries risk where isolation is compromised.\n* Known allergy or hypersensitivity to the components of the tested materials (e.g., resin composites, primers, adhesives).","ALL","4 Years","9 Years",{"count":117,"type":118},70,"ESTIMATED","INTERVENTIONAL",[121],"NA","The goal of this clinical trial is to compare the clinical performance of chemically-cured and light-cured bulk-fill composite materials used for Class II restorations in children aged 4 to 9 years with primary second molars. The main questions it aims to answer are:\n\nWhat are the clinical success rates of the restorations at 12 months based on modified FDI criteria?\n\nHow do the two materials compare regarding application times, clinician ease of use, and patient satisfaction?\n\nResearchers will compare the chemically-cured bulk-fill composite (Stela Capsule) to the light-cured bulk-fill composite (Filtek One) using a split-mouth design to see which material provides better long-term clinical performance and survival rates.\n\nParticipants will:\n\nReceive two different bulk-fill composite restorations in matched primary second molars within the same dental arch\n\nVisit the clinic for routine checkups and evaluations at 1 week, 3 months, 6 months, 12 months, 24 months, and 36 months",[124,125,126],"Decayed Primary Molars","Decayed Tooth","Dentin Caries",[128,129,130,131,132,133,134,135,136,137,138],"dental caries","pediatric dentistry","primary teeth","deciduous teeth","primary molars","Class II Restorations","Bulk-Fill Composite","Resin Composite","Dental Restoration","Chemically-Cured Composite","Light-Cured Composite","NOT_YET_RECRUITING","2026-10-06",{"date":142,"type":143},"2026-10-09","ACTUAL",{"date":145,"type":118},"2026-10-30",{"date":147,"type":118},"2027-04-30",{"name":102,"class":6},1]