[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606553":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":28,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":38,"eligibilityCriteria":39,"healthyVolunteers":34,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":11,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":52,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"Dubai Health","OTHER_GOV",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"hydroxyapatite tooth paste [ HAP] (study group)","ACTIVE_COMPARATOR",null,[13],"Drug: non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste)",{"label":15,"type":10,"description":11,"interventionNames":16},"Fluoride-containing tooth paste [1450ppm fluoride] (control group)",[17],"Drug: fluoridated toothpaste (Colgate Total PROTECTION ACTIVE)",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","non fluoridated hydroxyapatite tooth paste (KAREX KINDER tooth paste)","arm 1 : hydroxyapatite tooth paste \\[ HAP\\] (study group): assessment will involve Quantitative Light-Induced Fluorescence- QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence\n\n(ΔF, %) and extension of the lesion (area; mm2).",[9],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"fluoridated toothpaste (Colgate Total PROTECTION ACTIVE)","Arm 2 :Fluoride-containing tooth paste \\[1450ppm fluoride\\] (control group):\n\nassessment will involve Quantitative Light-Induced Fluorescence- QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence (ΔF, %) and extension of the lesion (area; mm2).",[15],{"type":29,"investigatorFullName":30,"investigatorTitle":31,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Shaima Buhamer","Specialist Pediatric Dentist","100606553","phase-2-hydroxyapatite-vs-fluoride-toothpaste-for-mih-remineralization-100606553",false,"NCT07177053","Hydroxyapatite vs Fluoride Toothpaste for MIH Remineralization","Comparative Clinical Evaluation of Remineralization of Molar Incisor Hypomineralization Using Hydroxyapatite vs. Fluoride Toothpaste","MIH-CARE","Inclusion Criteria:\n\n* at least one affected permanent molar or incisor\n* good general health\n* parental informed consent, and the child's assent\n\nExclusion Criteria:\n\n* Patients with systemic conditions affecting enamel or recent use of desensitizing treatments.","ALL","6 Years","12 Years",{"count":44,"type":45},160,"ESTIMATED","INTERVENTIONAL",[48],"PHASE2","Molar Incisor Hypomineralization (MIH) is a common developmental enamel defect affecting children, particularly in Dubai, where it contributes to hypersensitivity, esthetic concerns, plaque accumulation, and increased caries risk. These complications often lead to premature tooth extraction and orthodontic issues, negatively impacting children's oral health-related quality of life.\n\nThis randomized, open-label clinical trial aims to compare the remineralization efficacy of a fluoride-free hydroxyapatite toothpaste with a conventional fluoride toothpaste in children aged 6-12 years diagnosed with mild to moderate MIH.\n\nParticipants will be recruited from Dubai Health pediatric dental clinics, with inclusion criteria requiring at least one affected permanent molar or incisor, good general health, parental informed consent, and the child's assent. Children with systemic conditions affecting enamel or recent use of desensitizing treatments will be excluded.\n\nPrimary outcome assessment will involve Quantitative Light-Induced Fluorescence-QLF at baseline, 3, 6, 9, and 12 months. The images were analyzed using a commercial software program (Inspektor QLF 1.97, Inspektor Research Systems, Amsterdam, The Netherlands) to determine the change in fluorescence (ΔF, %) and extension of the lesion (area; mm2).\n\nSecondary outcome measures will include enamel fluorescence readings using the DIAGNOdent Pen. After prophylaxis and air-drying, three readings per lesion will be recorded, with mean and peak values analyzed to monitor mineralization. Hypersensitivity in MIH-affected teeth will be assessed using air stimulus (Schiff scale) and Visual Analogue Scale (VAS) at baseline, 3, 6, 9, and 12 months. Oral health-related quality of life (OHRQoL) will be measured using age-appropriate validated questionnaires to evaluate the impact of MIH and treatment over time.\n\nThis study also responds to growing parental concerns about fluoride exposure and the demand for safer, fluoride-free alternatives. By evaluating the clinical effectiveness of hydroxyapatite toothpaste, the trial aims to inform evidence-based preventive strategies for MIH management. The findings may guide clinical practice and public health recommendations, ultimately improving oral health outcomes for affected children.",[51],"Molar Incisor Hypomineralisation",[53,54,55,56,57,58],"Molar Incisor Hypomineralization (MIH)","Child","Remineralization","Hydroxyapatite Toothpaste","Fluoride Toothpaste","Quantitative Light-Induced Fluorescence(QLF)","NOT_YET_RECRUITING","2025-09-12",{"date":62,"type":63},"2025-09-16","ACTUAL",{"date":65,"type":45},"2025-11",{"date":67,"type":45},"2026-11",{"name":5,"class":6}]