[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597962":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":26,"responsibleParty":33,"collaborators":26,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":42,"acronym":26,"eligibilityCriteria":43,"healthyVolunteers":44,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":26,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":26},{"fullName":5,"class":6},"Al-Azhar University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Curodont Repair Fluoride Plus (P11-4 + fluoride)","EXPERIMENTAL","• In the Intervention group the Curodont Repair (P11-4 + fluoride) will be applied according to the manufacturer's instructions: The paste is gently applied to the dentin surface and left undisturbed for 5 minutes to allow self-assembly and infiltration and excess material will be removed with a gentle air spray",[13,14],"Drug: Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland","Drug: Beautifil II LS",{"label":16,"type":17,"description":18,"interventionNames":19},"Beautifil II LS","PLACEBO_COMPARATOR","No pretreatment; proceed directly to bonding. Then the surface will dry with absorbent paper. A layer of the adhesive system (BeautiBond extrem, Shofu Inc., Kyoto, Japan) will be actively applied for 20 seconds using a micro brush. Then, the adhesive will light-cure for 10 seconds with Radii-cal LED light curing device (1200 mW\u002Fcm2) (SDI, Bayswater, Australia) (2",[13,14],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Curodont Repair Fluoride Plus (Self-assembling peptide remineralization agent)P11-4 peptide, fluoride, mild acidic buffer (pH ~4.5) , Credentis AG, Switzerland","Pretreatment with Curodont Repair Fluoride Plus (P11-4 + fluoride)",[16,9],null,{"type":22,"name":16,"description":28,"armGroupLabels":29,"otherNames":30},"Application of Giomer restorative material following standard adhesive procedures without pretreatment.",[16,9],[31,32],"S-PRG (Surface Pre-Reacted Glass-ionomer) filler, Bis-GMA, TEGDMA, glass fillers , Shofu Inc., Kyoto, Japan","Giomer-based restorative composite",{"type":34,"investigatorFullName":35,"investigatorTitle":36,"investigatorAffiliation":37,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Fatheya Mansour Elshinawy","Assistant lecturer of Restorative Dentistry","Misr University for Science and Technology","100597962","early-phase-1-clinical-performance-and-remineralization-potential-of-self--assembling-peptide-p11-4-containing-fluoride-versus-er-cr-ysgg-laser-treatment-and-micro-tensile-bond-strength-of-giomer-restoration-in-carious-lesions-100597962",false,"NCT07065305","Clinical Performance and Remineralization Potential of Self- Assembling Peptide P11-4 Containing Fluoride Versus Er, Cr: YSGG Laser Treatment and Micro Tensile Bond Strength of Giomer Restoration in Carious Lesions","Inclusion Criteria:\n\n* o Patients aged (20 - 40) years.\n\n  * Presence of at least one posterior permanent molar with an occlusal carious lesion classified as ICDAS code 3 or 4 requiring operative treatment.\n  * Good general and oral health.\n  * Willingness to participate and provide informed consent.\n\nExclusion Criteria:\n\n* o Patients with systemic conditions affecting oral health or healing.\n\n  * Teeth with pulp involvement or periapical pathology.\n  * Allergy to study materials.\n  * Poor oral hygiene or periodontal disease in the target tooth region.",true,"ALL","20 Years","40 Years",{"count":49,"type":50},21,"ESTIMATED","INTERVENTIONAL",[53],"EARLY_PHASE1","This study will be performed in two parts, in vivo and in vitro to assess the effect of the remineralization potential of self-assembling peptide P11-4 containing Fluoride on caries-affected dentin compared to untreated caries-affected dentin and the influence of Er, Cr: YSGG Laser treatment.",[56,57],"Remineralization Potential","Dentin Caries",[59,60,56,61],"Er, Cr: YSGG Laser","Caries-Affected Dentin","Self-Assembling Peptide P11-4 Containing Fluoride","NOT_YET_RECRUITING","2025-07-24",{"date":65,"type":66},"2025-07-29","ACTUAL",{"date":68,"type":50},"2025-09-15",{"date":70,"type":50},"2026-09-15",{"name":5,"class":6}]