[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590649":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":32,"locations":38,"responsibleParty":75,"collaborators":78,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":18,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":102,"overallStatus":41,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"University Hospital, Basel, Switzerland","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"AI-Designed Passive Plate Therapy","EXPERIMENTAL","Infants in this group will receive passive plate therapy designed using an AI-assisted digital workflow. The plate is fitted shortly after birth and worn continuously until the time of primary surgical repair (around 4 months of age). Participants in this arm will undergo intraoral scans at birth and again at surgery.",[13],"Other: AI-Designed Passive Plate Therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"No Presurgical Therapy","NO_INTERVENTION","Infants in this group will not receive any presurgical orthopedic intervention. They will undergo a single intraoral scan at the time of primary surgical repair (around 4 months of age), which will be used for comparison with the intervention group.",null,[20],{"type":6,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"A removable passive orthopedic plate designed using an AI-assisted digital workflow based on intraoral scan data. The design process is automated via a Blender-based software plugin that identifies anatomical landmarks and generates a custom-fit plate. The plate is 3D printed using biocompatible material and fitted shortly after birth. It is worn continuously until primary surgical repair, typically around 4 months of age. The intervention aims to reduce cleft width prior to surgery without requiring traditional impressions or extensive manual design effort.",[9],[24],"Automated Passive Plate",[26,29],{"name":27,"affiliation":5,"role":28},"Andreas Mueller, PhD,MHBA","STUDY_CHAIR",{"name":30,"affiliation":5,"role":31},"Prasad Nalabothu, MDS PhD","PRINCIPAL_INVESTIGATOR",[33],{"name":34,"role":35,"phone":36,"phoneExt":18,"email":37},"Prasad Nalabothu, PhD","CONTACT","+41765014420","p.nalabothu@usb.ch",[39,59],{"facility":40,"status":41,"city":42,"state":18,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Saveetha Medical College","RECRUITING","Chennai","602105","India","IN",{"type":47,"coordinates":48},"Point",[49,50],80.27847,13.08784,{"lat":50,"lon":49},[53,57],{"name":54,"role":35,"phone":55,"phoneExt":18,"email":56},"Praveen Ganesh Prof. Dr., MDS, FDS RCPS","+919972152140","prgfacsurg@gmail.com",{"name":58,"role":31,"phone":18,"phoneExt":18,"email":18},"Praveen Ganesh Prof. Dr. Ganesh, MDS, FDS RCPS",{"facility":60,"status":41,"city":61,"state":18,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"GSR Hospital Hyderabad","Hyderabad","500059",{"type":47,"coordinates":64},[65,66],78.45636,17.38405,{"lat":66,"lon":65},[69,73],{"name":70,"role":35,"phone":71,"phoneExt":18,"email":72},"Hemwati Nandan, MDS","+919997703789","hemwatinandanbahuguna@gmail.com",{"name":74,"role":31,"phone":18,"phoneExt":18,"email":18},"Srinivas Gosla Prof. Dr. Reddy, MBBS, MDS, Phd",{"type":31,"investigatorFullName":76,"investigatorTitle":77,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Prasad Nalabothu","Prinicipal Investigator",[79],{"name":80,"class":6},"University of Basel","100590649","clinical-application-of-artificial-intelligence-in-new-borns-with-cleft-lip-and-palate-100590649",false,"NCT06970158","Clinical Application of Artificial Intelligence in New Borns With Cleft Lip and Palate","Effect of Automated AI Designed Presurgical Plate Therapy on Cleft Size Reduction in Newborns With Cleft Lip and Palate : A Comparative Study","CLIP-AI","Inclusion criteria:\n\nInfants diagnosed with unilateral cleft lip and palate Age at enrollment: within the first 14 days of life (for treatment group) Age at cleft surgery: approximately 4 months Medically stable and fit to undergo intraoral scanning and cleft surgery Parent or legal guardian has provided written informed consent\n\nExclusion Criteria:\n\nSyndromic cleft lip and palate or other craniofacial syndromes Bilateral cleft lip and palate Significant comorbidities affecting feeding, growth, or surgery (e.g., cardiac anomalies) Premature infants (\\\u003C37 weeks gestational age at birth) Infants who have already undergone any presurgical orthopedic intervention elsewhere Guardians\u002F Parents unwilling or unable to comply with follow-up or study procedures","ALL","1 Day","6 Months",{"count":93,"type":94},70,"ESTIMATED","INTERVENTIONAL",[97],"NA","The goal of this observational study is to evaluate whether passive plate therapy using automated AI-designed devices can reduce cleft size in newborns with cleft lip and palate. The main questions it aims to answer are:\n\nDoes AI-designed passive plate therapy reduce the cleft size between birth and primary surgery? (Primary aim)\n\nHow does cleft size at the time of surgery compare between infants who received passive plate therapy and those who did not? (Secondary aim)\n\nResearchers will compare infants who received AI-designed passive plate therapy with those who received no presurgical therapy to determine whether the intervention leads to a greater reduction in cleft width.\n\nParticipants will: Undergo intraoral scans at birth and again at the time of primary surgery, around 4 months of age.\n\nReceive either no presurgical intervention or be treated with AI-designed passive plates, depending on site-specific clinical practices",[100,101],"Congenital Disorder","Cleft Lip Palate",[103,101],"artificial intelligence","2025-05-13",{"date":106,"type":107},"2025-05-16","ACTUAL",{"date":109,"type":107},"2023-08-01",{"date":111,"type":94},"2025-12-31",{"name":5,"class":6},2]