[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644323":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":34,"centralContacts":38,"locations":44,"responsibleParty":68,"collaborators":29,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":29,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":47,"whyStopped":29,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Medical University of Warsaw","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Application of Curodont Repair Plus Fluoride Varnish","EXPERIMENTAL","Participants will receive a single application of Curodont Repair (self-assembling peptide P11-4) at the first visit (baseline) and fluoride varnish application every 3 months (including baseline visit)",[13,14],"Other: Self-assembling peptide P11-4","Other: Fluoride varnish",{"label":16,"type":10,"description":17,"interventionNames":18},"Repeated Application of Curodont Repair Plus Fluoride Varnish","Participants will receive applications of Curodont Repair (self-assembling peptide P11-4) at the first visit (baseline), after 3 months, together with fluoride varnish application every 3 months (including baseline visit).",[13,14],{"label":20,"type":21,"description":22,"interventionNames":23},"Fluoride Varnish Only","ACTIVE_COMPARATOR","Participants will receive fluoride varnish application every 3 months only.",[14],[25,30],{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"Self-assembling peptide P11-4","Self-assembling peptide P11-4 will be applied on enamel carious white spot lesions according to the study protocol. In the single-application group (group A), the agent will be applied once at the first visit(baseline). In the repeated-application group (group B), the agent will be applied at the first visit (baseline) and after 3 months.",[16,9],null,{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":29},"Fluoride varnish","Fluoride varnish will be applied every 3 months according to the study protocol.",[20,16,9],[35],{"name":36,"affiliation":5,"role":37},"Dorota Olczak-Kowalczyk, Prof.","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":29,"email":43},"Anna Turska-Szybka","CONTACT","+48 22 116 64 24","pedodoncja@wum.edu.pl",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University Clinical Center of the Medical University of Warsaw, Department of Pediatric Dentistry","RECRUITING","Warsaw","Masovian Voivodeship","02-097","Poland","PL",{"type":54,"coordinates":55},"Point",[56,57],21.01178,52.22977,{"lat":57,"lon":56},[60,62,63,66],{"name":61,"role":41,"phone":42,"phoneExt":29,"email":43},"Secretariat of the Department of Pediatric Dentistry",{"name":36,"role":37,"phone":29,"phoneExt":29,"email":29},{"name":64,"role":65,"phone":29,"phoneExt":29,"email":29},"Anna Turska-Szybka, Assoc. Prof.","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":29,"phoneExt":29,"email":29},"Julia Sazonowa, Dr.",{"type":37,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Dorota Olczak-Kowalczyk","Proffesor","100644323","the-effectiveness-of-the-self-assembling-peptide-p11-4-in-the-remineralization-of-enamel-carious-white-spot-lesions-100644323",false,"NCT07664046","The Effectiveness of the Self-Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions","A Three-arm Randomized Controlled Trial Evaluating the Effectiveness of Self- Assembling Peptide P11-4 in the Remineralization of Enamel Carious White Spot Lesions","WSL-Curodont","Inclusion Criteria:\n\n1. Age \\>10 years and \\\u003C18 years.\n2. Presence of at least 2 active enamel carious white spot lesions on a smooth tooth surface (labial\u002Fbuccal surfaces of permanent teeth) based on International Caries Detection (ICDAS II) and Assessment System -Lesion Activity Assessment (ICDAS-LAA), and Lesion Activity Assessment (LAA criteria).\n3. Tooth eligible for treatment:\n\n   1. Vital pulp,\n   2. no loss of hard dental tissues within the investigated lesion (ICDAS II) code 1 or 2 , LAA code 1, ICDAS-LAA\\>7;\n   3. QLF score parameters consistent with demineralization without loss of tissue continuity- code 1 or 2),\n   4. no history of trauma to the tooth.\n4. Systemically healthy patient.\n5. No contraindications to the use of fluoride preparations.\n6. No fixed orthodontic appliance.\n7. Written consent for participation in the study signed by the legal guardian, or by the legal guardian and the patient.\n\nExclusion Criteria:\n\n1. Systemic diseases or chronic medication use due to chronic conditions.\n2. Viral\u002Fbacterial illness on the day of the visit, e.g., herpetic stomatitis, influenza, tonsillitis (temporary restriction).\n3. Pregnancy or breastfeeding.\n4. Allergy to any component of the SAP P11-4 preparation or the fluoride varnish.\n5. Professional fluoride prophylaxis performed \\\u003C3 months ago.\n6. Presence of cavitation (loss of hard tissues) in the treated tooth - ICDAS II code ≥3, ICDAS-LAA\\\u003C7, LAA code 0, 2-9.\n7. Carious WSL previously treated with the Icon resin infiltrant (methacrylate resin).\n8. Developmental enamel defects.\n9. Patient undergoing orthodontic treatment with fixed appliances.\n10. Inability to ensure regular follow-up visits.\n11. Lack of cooperation from the guardian or the patient.\n12. Refusal to participate in the study and\u002For absence of written consent.","ALL","10 Years","18 Years",{"count":83,"type":84},75,"ESTIMATED","INTERVENTIONAL",[87],"NA","This is three-arm Randomized Controlled Trial. The main goal is to evaluate the effectiveness of self-assembling peptide P11-4 (SAP P11-4) in the remineralization of enamel carious white spot lesions. Participants with carious white spot lesions will be assigned to one of three study groups and remineralisation agents will be applied according to the study protocol. The primary objective is to assess changes in the carious white spot lesions over time using quantitative light-induced fluorescence and clinical evaluation.",[90],"White Spot Lesions on Smooth Surface of Tooth",[92,93,94,95,96,97,98,99],"Curodont Repair","SAP P11-4","Self-Assembling Peptide P11-4","Remineralisation","Quantitative Light-Induced Fluorescence","Fluoride Varnish","Pediatric Dentistry","White Spot Lesions","2026-06-16",{"date":102,"type":103},"2026-06-23","ACTUAL",{"date":105,"type":103},"2026-02-02",{"date":107,"type":84},"2027-12-14",{"name":5,"class":6},1]