[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561383":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":30,"locations":11,"responsibleParty":40,"collaborators":11,"id":44,"slug":45,"hasResults":46,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":46,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":11,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":11},{"fullName":5,"class":6},"Cairo University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nasal stent with Digital Nasoalveolar molding","ACTIVE_COMPARATOR",null,[13],"Device: Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants",{"label":15,"type":16,"description":17,"interventionNames":18},"Nasal elevator with Digital Nasoalveolar molding","EXPERIMENTAL","Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants.",[19],"Device: Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants",[21,26],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DEVICE","Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants","This is a unique nasal elevator aiming to improve nasolabial esthetics in conjunction with digital nasoalveolar molding appliance when used in bilateral cleft lip and palate infants.",[15],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants","Nasal stent that is used in conjunction with digital nasoalveolar molding in bilateral cleft lip and palate infants",[9],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":11,"email":35},"Donia Ayman Ahmed Ezzeldin, PhD","CONTACT","00201001200089","donia.ayman@dentistry.cu.edu.eg",{"name":37,"role":33,"phone":38,"phoneExt":11,"email":39},"Mohamed Abd-El-Ghafour Omar","00201007433288","m.abdelghafour@dentistry.cu.edu.eg",{"type":41,"investigatorFullName":42,"investigatorTitle":43,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR",": Donia Ayman Ahmed Ezzeldin ElSayed","Assistant lecturer at Orthodontic Department, Cairo University","100561383","phase-1-evaluation-of-nasal-elevator-versus-graysons-nasal-stent-with-d-nam-appliance-on-nasolabial-esthetics-in-bilateral-cleft-lip-and-palate-infants-100561383",false,"NCT06589453","Evaluation of Nasal Elevator Versus Grayson's Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants","Evaluation of Nasal Elevator Versus Grayson's Nasal Stent in Conjunction with Digital Nasoalveolar Molding (D-NAM) Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate: a Randomized Clinical Trial","D-NAM","Inclusion Criteria:\n\n* Non-syndromic Infants with complete BCLP infants\n* Infants less than 1 month of age.\n* Males and females.\n* Infants with displaced premaxilla\n* Patients whose parents provided written consent for the study.\n\nExclusion Criteria:\n\n* Patients above 1 month of age.\n* Syndromic and systemically ill infants.\n* Patients with unilateral cleft lip and palate.\n* Incomplete Cleft lip or Simonart band (soft tissue bridge at the cleft side).\n* Medically compromised patients\n* Patien parents\u002Fguardians who will be unwilling to go through the Naso-alveolar molding (NAM) therapy.","ALL","1 Day","1 Month",{"count":56,"type":57},20,"ESTIMATED","INTERVENTIONAL",[60],"PHASE1","Newborns with bilateral cleft lip\u002F palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics.",[63],"Cleft Lip and Cleft Palate",[65],"Cleft lip and palate","NOT_YET_RECRUITING","2024-10-16",{"date":69,"type":70},"2024-10-17","ACTUAL",{"date":72,"type":57},"2024-11-01",{"date":74,"type":57},"2026-10-01",{"name":5,"class":6}]