[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576072":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":32,"locations":12,"responsibleParty":38,"collaborators":12,"id":42,"slug":43,"hasResults":44,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":12,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":65,"whyStopped":12,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":12},{"fullName":5,"class":6},"Cairo University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Control group","NO_INTERVENTION","Application of resin composite restoration after partial caries removal without application of dentin pretreatment or biomodifier.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Intervention group","EXPERIMENTAL","Application of resin composite restoration after partial caries removal with application of 15% GSE as dentin pretreatment.",[18],"Other: 15% Grape seed extract as dentin pretreatment",[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":12},"15% Grape seed extract as dentin pretreatment","using proanthocyanidin-rich grape seed extract as a biomodifier for dentin improved the mechanical properties of dental collagen by cross-linking and dehydrating fibrils. This made the collagen substrate more suitable for hybridization. It also acted as a non-specific MMP-inhibitor, protecting exposed collagen fibrils from biodegradation from dentin proteases.",[14],[25,29],{"name":26,"affiliation":27,"role":28},"Pro. Heba Salah El Din Hamza (H.H.) Head of Conservative Dentistry Department, Cairo University., Professor","Professor, Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt.","STUDY_DIRECTOR",{"name":30,"affiliation":31,"role":28},"Dr. Rawda Hesham Abd ElAziz (R.H.) Lecturer of Conservative Dentistry Department,Cairo University, Lecturer","Lecturer of Conservative Dentistry Department, Faculty of Dentistry, Cairo University, Egypt.",[33],{"name":34,"role":35,"phone":36,"phoneExt":12,"email":37},"Marwah Faker Mohammed Al-Emad (M.F.) Master's student, Master","CONTACT","(+2) 01116398243","marwah.faker@dentistry.cu.edu.eg",{"type":39,"investigatorFullName":40,"investigatorTitle":41,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Marwah Faker Mohammed Al-Emad","Master's student","100576072","clinical-performance-of-resin-composite-restoration-after-dentin-biomodification-by-grape-seed-extract-in-deep-carious-lesions-100576072",false,"NCT06780527","Clinical Performance of Resin Composite Restoration After Dentin Biomodification by Grape Seed Extract in Deep Carious Lesions.","Clinical Performance and Radiographic Assessment of Resin Composite Restoration After Dentin Biomodification by Grape Seed Extract in Vital Teeth With Deep Occlusal Carious Lesions. \"18-M Randomized Clinical Trial\"","GSE","Inclusion Criteria:\n\n* Patient-related criteria:\n\n  1. Adult patients (age: 22-42 years) of both genders.\n  2. Good oral hygiene.\n  3. Willing to sign the informed consent.\n  4. Co-operative patients who accept the follow-up period.\n* Tooth-related criteria:\n\n  1. Posterior permanent caries (ICDAS 5\\&6).\n  2. Radiographically, caries is extending 50% of dentine with a radiopaque layer between the carious lesion and the pulp chamber.\n  3. Sensible teeth according to cold pulp test.\n  4. Negative response in percussion test.\n\nExclusion Criteria:\n\n* Patient-related criteria:\n\n  1. Allergy to any of the restorative materials.\n  2. Patients undergoing orthodontic treatment with fixed appliances.\n  3. Pregnant women.\n  4. Patients with debilitating systemic diseases.\n  5. Patient who frequently use analgesic or any drugs that could mask the pain.\n* Tooth-related criteria:\n\n  1. Teeth with previous restorations.\n  2. Spontaneous pain or prolonged pain (more than 15 s) after sensitivity test (cold test), which would indicate irreversible pulpitis.\n  3. Negative sensibility tests, periapical radiolucencies and sensitivity to axial or lateral percussion.\n  4. Mobile teeth, indicating periodontal disease or trauma.\n  5. External or internal resorption.\n  6. Chipped teeth or Cuspal loss",true,"ALL","22 Years","42 Years",{"count":55,"type":56},60,"ESTIMATED","INTERVENTIONAL",[59],"NA","This study will evaluate the clinical and radiographic performance of resin composite restoration after utilized a grape seed extract as dentin biomodification in vital teeth with deep occlusal carious lesions (ICDAS 5-6) after selective soft dentin removal technique.",[62],"Deep Carious Lesions",[64],"Deep caries, Partial caries removal, Grape seed extract,","NOT_YET_RECRUITING","2025-01-13",{"date":68,"type":69},"2025-01-17","ACTUAL",{"date":71,"type":56},"2025-06-01",{"date":73,"type":56},"2027-03-01",{"name":5,"class":6}]