[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606147":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":26,"responsibleParty":37,"collaborators":26,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":26,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":26,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":69,"whyStopped":26,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":26},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Bioactive Restorative System","EXPERIMENTAL","Experimental Group (Bioactive Restorative System):",[13],"Procedure: Experimental - Bioactive Restorative System",{"label":15,"type":16,"description":17,"interventionNames":18},"Conventional Restorative System","ACTIVE_COMPARATOR","Control Group (Conventional Restorative System)",[19],"Procedure: Active Comparator -Conventional Restorative System",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Experimental - Bioactive Restorative System","Following selective caries removal to soft dentin, the cavity will be restored using a bioactive restorative system consisting of a bioactive universal adhesive followed by placement of a bioactive bulk-fill resin composite.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Active Comparator -Conventional Restorative System","Following selective caries removal to soft dentin, the cavity will be restored using a conventional universal adhesive system followed by placement of a bulk-fill resin composite",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Esraa Hamdy Saber E.H. Assistant lecturer, PhD","CONTACT","(+2) 01010200882","esraah.hamdy@dentistry.cu.edu.eg",{"type":38,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Esraa Hamdy Saber Mohamed","Assistant lecturer","100606147","this-study-aims-to-clinically-assess-and-radiographically-measure-the-formed-dentin-bridge-over-the-pulp-utilizing-three-dimensional-imaging-following-the-application-of-a-bioactive-restorative-system-versus-a-conventional-restorative-system-after-selective-caries-removal-to-soft-dentin-over-2-100606147",false,"NCT07171775","This Study Aims to Clinically Assess and Radiographically Measure the Formed Dentin Bridge Over the Pulp, Utilizing Three-dimensional Imaging Following the Application of a Bioactive Restorative System Versus a Conventional Restorative System After Selective Caries Removal to Soft Dentin Over 2","Clinical and Three-Dimensional Radiographic Assessment of Bioactive Restorative System Following Selective Caries Removal of Deep Lesions: A Two-Year Randomized Controlled Trial","Inclusion Criteria:\n\nPatient-related criteria:\n\n1. Adult patients (age: 18-40 years) of both genders.\n2. Good oral hygiene.\n3. Willing to sign the informed consent.\n4. Cooperative patients who accept the follow-up period.\n\nTooth-related criteria:\n\n1. Posterior permanent caries (ICDAS 5-6).\n2. Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.\n3. Sensitive teeth according to the cold pulp test.\n4. Negative response in percussion test.\n\nExclusion Criteria:\n\nPatient-related criteria:\n\n1. Allergy to any of the restorative materials.\n2. Patients undergoing orthodontic treatment with fixed appliances.\n3. Pregnant women.\n4. Patients with debilitating systemic diseases.\n5. Patient who frequently uses analgesics or any drugs that could mask the pain.\n\nTooth-related criteria:\n\n1. Teeth with previous restorations.\n2. Spontaneous pain or prolonged pain (more than 15 s) after the sensitivity test (cold test), which would indicate irreversible pulpitis.\n3. Negative sensibility tests, periapical radiolucency, and sensitivity to axial or lateral percussion.\n4. Mobile teeth, indicating periodontal disease or trauma.\n5. External or internal resorption.\n6. Chipped teeth or Cuspal loss","ALL","18 Years","40 Years",{"count":52,"type":53},66,"ESTIMATED","INTERVENTIONAL",[56],"NA","This clinical trial aims to evaluate dentin bridge formation over the pulp following selective caries removal in permanent teeth with deep carious lesions (ICDAS scores 5-6). A total of 66 patients will be enrolled and randomly allocated to receive either a bioactive restorative system (bioactive universal adhesive combined with a bioactive bulk-fill resin composite) or a conventional non-bioactive restorative system. Clinical assessments, including pulp sensibility testing and patient-reported pain evaluation, together with three-dimensional radiographic analysis using cone beam computed tomography, will be conducted to assess the thickness and quality of reparative dentin bridge formation. Outcomes will be evaluated at baseline and during follow-up periods extending up to 24 months to compare the effectiveness of both restorative approaches in preserving pulp sensibility and promoting dentin-pulp complex repair.",[59,60,61],"Deep Carious Lesions","Partial Caries Removal","Dentin Bridge",[63,64,65,66,67,68],"deep caries","partial caries removal","selective caries removal","dentin bridge","Bioactive","universal adhesive","NOT_YET_RECRUITING","2026-01-17",{"date":72,"type":73},"2026-01-21","ACTUAL",{"date":75,"type":53},"2026-06-01",{"date":77,"type":53},"2028-06-01",{"name":5,"class":6}]