[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621725":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":30,"responsibleParty":50,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":33,"whyStopped":25,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"October University for Modern Sciences and Arts","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"ibuprofen 100mg\u002Fml oral suspension syrup","EXPERIMENTAL","The analgesic will be labeled A; (ibuprofen 100 mg\u002Fml oral suspension). Administration of analgesic will be 30 mins prior to procedure.\n\nThe Operator who will perform the restorative treatment, the participant, and their guardian will not know which suspension will be administered (analgesic or placebo) or who analyzed the data. Only the professional who will administer the drug or placebo to the child and an external dental professional will know which will be used for each child, in case of any complications during the procedure.\n\nLocal anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000.\n\nRubber dam will be applied, then defect removal and cavity preparation and restorative treatment will be established.",[13],"Drug: ibuprofen 100mg\u002Fml oral suspension syrup",{"label":15,"type":16,"description":17,"interventionNames":18},"placebo","PLACEBO_COMPARATOR","The placebo will be labeled B and will be sharing the same characteristics and flavor as the analgesic. Administration of placebo will be 30 mins prior to procedure.\n\nThe Operator who will perform the restorative treatment, the participant, and their guardian will not know which suspension will be administered (analgesic or placebo) or who analyzed the data. Only the professional who will administer the drug or placebo to the child and an external dental professional will know which will be used for each child, in case of any complications during the procedure.\n\nLocal anesthesia administration using 1.8-mL of articaine 4% with epinephrine 1:100000.\n\nRubber dam will be applied, then defect removal and cavity preparation and restorative treatment will be established.",[19],"Drug: Placebo",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","ibuprofen 100 mg\u002Fml oral suspension administration 30 mins prior to procedure to assess the effect of preemptive analgesia on pain perception and anxiety management during restorative treatment of first permanent molars in children with molar incisor hypo-mineralization affected molars.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Placebo","the placebo will be labeled B and will be sharing the same characteristics and flavor as the analgesic. Administration placebo will be 30 mins prior to procedure to assess the effect of preemptive analgesia on pain perception and anxiety management during restorative treatment of first permanent molars in children with molar incisor hypo-mineralization affected molars.",[15],[31],{"facility":32,"status":33,"city":34,"state":25,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"October university of modern science and arts","RECRUITING","Giza","12611","Egypt","EG",{"type":39,"coordinates":40},"Point",[41,42],31.20861,30.00944,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Esraa Diaaeldin Elhenie, bachelor","CONTACT","00201094007206","ediaaeldin@msa.edu.eg",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Esraa Diaaeldin Nady Elhenie","general practitioner","100621725","preemptive-analgesia-for-pain-and-anxiety-control-in-children-with-mih-100621725",false,"NCT07374354","Preemptive Analgesia for Pain and Anxiety Control in Children With MIH","Assessment of Preemptive\u002FPreoperative Analgesia Effect on Pain Perception and Anxiety Management in Children With Molar Incisor Hypo-Mineralization During Restorative Treatment of First Permanent Molar: A Triple-Blinded Randomized Clinical Trial.","Inclusion Criteria:\n\n1. Patient with molar incisor hypo-mineralization.\n2. Patient's age ranges from 6 to 12 years old.\n3. The affected tooth has demarcated opacity with post eruptive enamel breakdown.\n4. No cavitated lesion is related to the defect of previous restorative or preventive treatment.\n\nExclusion Criteria:\n\n1. Children who are physically or mentally disabled or having any medical condition that will affect or complicate assessment of the intervention.\n2. Loss of tooth structure due to caries.\n3. intolerance to ibuprofen.\n4. developmental defects, including amelogenesis imperfecta and dentinogenesis imperfecta.","ALL","6 Years","12 Years",{"count":65,"type":66},46,"ESTIMATED","INTERVENTIONAL",[69],"NA","This randomized, triple-blinded clinical trial aims to evaluate the effect of preemptive analgesia using ibuprofen on pain perception and anxiety during restorative treatment of first permanent molars in children diagnosed with molar-incisor hypomineralization (MIH). MIH-affected teeth often present with hypersensitivity, difficulty in achieving adequate anesthesia, and increased dental anxiety, which complicates dental treatment. Participants aged 6-12 years with MIH will receive either ibuprofen syrup or placebo 30 minutes before treatment. Pain will be assessed using the FLACC Behavioral Pain Scale and Wong-Baker FACES scale, and anxiety will be evaluated through heart rate and oxygen saturation. The results will determine whether preoperative ibuprofen reduces intraoperative pain and improves anxiety control in this population.",[72],"Pain and Anxiety in Children With MIH",[74,75,76,77,78,79,80,81,82,83],"Molar Incisor Hypomineralization (MIH)","Preemptive Analgesia","Ibuprofen","Dental Pain","Dental Anxiety","FLACC Scale","Wong-Baker FACES","Post-Eruptive Enamel Breakdown","Children 6-12 Years","Analgesic Efficacy","2026-01-25",{"date":86,"type":87},"2026-01-28","ACTUAL",{"date":89,"type":66},"2026-02",{"date":91,"type":66},"2026-02-01",{"name":5,"class":6},1]