[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570533":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":46,"locations":55,"responsibleParty":65,"collaborators":69,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":45,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":45,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":57,"whyStopped":45,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":106},{"fullName":5,"class":6},"October 6 University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Self-Assembling Peptide (P11-4)","EXPERIMENTAL","self-assembling peptide in a brush-on liquid applied after cleaning and chemical preparation.The P11-4 peptide, called Curodont Repair (Credentis; now manufactured by vVARDIS)",[13],"Drug: P11-4, a self-assembling peptide",{"label":15,"type":10,"description":16,"interventionNames":17},"Self-Assembling Peptide (P11-4) with fluoride varnish","CR Fluoride Plus (CRFP) (Credentis; now manufactured by vVARDIS) also includes 500 ppm sodium fluoride and is registered with the US Food and Drug Administration (NDC 72247-101) as an anticaries drug under the fluoride monograph (21CFR355).",[18],"Drug: P11-4, a self-assembling peptide with flouride",{"label":20,"type":21,"description":22,"interventionNames":23},"Resin Infilteration","ACTIVE_COMPARATOR","ICON® contains 15% HCl as an etchant, ethanol as a dehydrating agent, and triethylene glycol dimethacrylate (TEGDMA) resin as an infiltrant",[24],"Drug: resin infilteration",[26,33,39],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","P11-4, a self-assembling peptide","rationally designed peptide, the monomers of which self-assemble into a biocompatible fibrillar scaffold that mimics the enamel matrix in response to particular environmental cues",[9],[32],"Curodont- repair",{"type":27,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"P11-4, a self-assembling peptide with flouride","self assembling peptide with 500 ppm sodium fluoride",[15],[38],"Curodont- repair with fouride",{"type":27,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"resin infilteration","Improvement of white spot lesions appearance by infiltration occurs due to a change in the refractive index since the refractive index of enamel (1.62-1.65) is different than that of air (1.00). Infiltration of the lesions with an infiltrate that has a refractive index of 1.52 is able to mask the lesion",[20],[44],"Icon",null,[47,52],{"name":48,"role":49,"phone":50,"phoneExt":45,"email":51},"Dina El Kharadly, PHD","CONTACT","02 38355276","dina.yousry.dent@o6u.edu.eg",{"name":53,"role":49,"phone":50,"phoneExt":45,"email":54},"nada adel","nada.adel.dent@o6u.edu.eg",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":45,"country":60,"countryCode":61,"cosmosGeoPoint":45,"geoPoint":45,"contacts":62},"RECRUITING","Cairo","Giza Governorate","Egypt","EG",[63],{"name":64,"role":49,"phone":50,"phoneExt":45,"email":51},"Dina EL Kharadly, PHD",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"PRINCIPAL_INVESTIGATOR","Dina El Kharadly","Lecturer in Pediatric Dentistry Department",[70,72],{"name":71,"class":6},"Al-Azhar University",{"name":73,"class":74},"University of Science and Technology of Fujairah","UNKNOWN","100570533","early-phase-1-resin-infiltration-vs-self-assembling-peptide-p11-4-in-treating-white-spot-lesions-100570533",false,"NCT06708481","Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesions","Clinical Outcome of Resin Infiltration Vs Self-Assembling Peptide (P11-4) in Treating White Spot Lesion - a Randomized Clinical Trial","Inclusion Criteria:\n\n* Age (a range from 7-14 years of age was determined)\n* Good general health (absence of disease\u002Fno handicaps, to ensure oral care at home)\n* Preserved pulp vitality of the teeth.\n* Consolidated oral care daily.\n* Agreement by patient and parents (or guardians) to participate in the study\n\nExclusion Criteria:\n\n* Patients with periodontal diseases (periodontal pockets or dental mobility) or radiologically identified pathologies (periapical radiolucency).\n* Teeth revealing any restorations were excluded from the current study.\n* Any previous or planned WSL treatment.",true,"ALL","7 Years","14 Years",{"count":87,"type":88},150,"ESTIMATED","INTERVENTIONAL",[91],"EARLY_PHASE1","Clinical assessment of the effectiveness of two treatment modalities (self-assembling peptide (P11-4) (alone or combined with fluoride) and resin infiltration) for treating white spot lesions",[94],"White Spot Lesion",[96],"Resin Infilteration , white spot lesions , Self assembling peptide, remineralization","2024-11-25",{"date":99,"type":100},"2024-11-27","ACTUAL",{"date":102,"type":100},"2024-08-30",{"date":104,"type":88},"2025-02",{"name":5,"class":6},1]