[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cleft-lip-palate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cleft-lip-palate":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,76,114,141],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100635814","effect-of-opioid-free-vs-opioid-based-anesthesia-on-postoperative-pain-and-emergence-agitation-in-children-undergoing-cleft-surgery-100635814",false,"NCT07557576","Effect of Opioid-Free vs Opioid-Based Anesthesia on Postoperative Pain and Emergence Agitation in Children Undergoing Cleft Surgery","Comparison of Impact of Opioid and Non-Opioid Anesthesia on Pain and Agitation Levels in Children After Cleft Lip and Palate Surgery","Inclusion Criteria:\n\n* ASA physical status I-II\n* Body weight \\>5 kg\n* Age ≥3 months for cleft lip repair and ≥9 months for cleft palate repair\n* Hemoglobin \\>100 g\u002FL\n\nExclusion Criteria:\n\n* ASA physical status III-IV\n* Body weight \\\u003C5 kg\n* Age \\\u003C3 months for cleft lip repair or \\\u003C9 months for cleft palate repair\n* Hemoglobin \\\u003C100 g\u002FL\n* Acute illness\n* Respiratory infection or vaccination within 2 weeks prior to surgery\n* Requirement for perioperative intensive care","ALL","3 Months","7 Years",{"count":20,"type":21},90,"ESTIMATED","INTERVENTIONAL",[24],"NA","Orofacial clefts are among the most common congenital malformations, affecting approximately 1 in 700-1500 live births worldwide. They are associated not only with aesthetic concerns but also with functional impairments in feeding, speech, hearing, and dentition, and may be accompanied by other systemic malformations, often requiring multiple surgical procedures and long-term multidisciplinary care. Although cognitive development is preserved, the psychosocial impact on both children and families can be significant.\n\nAnesthesia in children with clefts presents specific challenges. Airway management is often more difficult due to anatomical variations, particularly in syndromic patients and those under 1 year of age. Immature organ systems affect drug metabolism, requiring careful dose adjustment. Preoperative anxiety and stress responses are common and may contribute to complications such as laryngospasm and bronchospasm. In the postoperative period, emergence agitation (EA) and emergence delirium (ED) are frequent, with reported incidence up to 80%. These conditions are characterized by restlessness, inconsolability, and disorientation, and may result in self-injury or disruption of surgical repairs.\n\nDifferentiating agitation from pain is challenging in young children due to limited communication abilities. Validated observational tools such as CHIPPS, PAEDS, and Cravero scales are used for routine clinical assessment of pain and EA\u002FED, although their subjective nature may limit accuracy. Therefore, evaluation of the perioperative serum cortisol, alpha-amylase, and neuropeptide Y levels will be used. These biomarkers reflect activation of the physiological stress response and indirectly indicate the presence and intensity of pain.\n\nPain management requires a multimodal approach. While opioids remain standard, their use is associated with adverse effects such as respiratory depression, nausea, vomiting, and delayed recovery. Consequently, opioid-free (OF) strategies using different anesthetics, including ketamine and dexmedetomidine have gained attention.\n\nThis prospective randomized clinical trial will compare opioid-based anesthesia with an opioid-free protocol in children undergoing cleft surgery. A total of 90 patients age of 3 months-7 years will be randomized in a 1:1 ratio. The opioid group will receive fentanyl, while the OF group will receive ketamine and dexmedetomidine; both groups will receive propofol, vecuronium, sevoflurane, and nitrous oxide.\n\nPrimary outcomes are postoperative pain (CHIPPS) and emergence agitation (PAEDS, Cravero). Pain will be assessed at 5 min, 15 min, 1, 2, 12, and 24 h after extubation, whereas emergence agitation will be evaluated at 5 min, 15 min, 1 h, and 2 h post-extubation. While these scales are routinely used in clinical practice, their subjective nature necessitates additional objective assessment. Therefore, secondary outcomes include evaluation of perioperative stress markers (cortisol, alpha-amylase, neuropeptide Y) and adverse events (nausea, vomiting, pruritus, constipation, respiratory depression, altered consciousness) within 24 h. Procedures will be standardized, with morning surgeries to minimize circadian variations of the biomarkers, performed by the same team. Blood samples will be collected before and after intravenous induction.\n\nPostoperative analgesia will include paracetamol and NSAIDs, with fentanyl as rescue therapy.\n\nThe study hypothesis is that opioid-free anesthesia will provide comparable or superior analgesia, reduce the incidence of emergence agitation, attenuate the stress response, and decrease opioid-related adverse effects, thereby improving overall perioperative safety and recovery in pediatric patients undergoing cleft surgery.\n\nThe particular value of this study lies in the subgroup of children who will undergo at least two surgical procedures within the observation period. In these patients, each child will be exposed to both anesthetic protocols in separate procedures-once according to the randomly assigned regimen and the second time according to the alternative protocol. In this way, each patient serves as their own control, allowing for a more precise comparison of outcomes with a substantial reduction in inter-individual variability. This approach largely eliminates individual differences such as age, body weight, baseline hemodynamic status, individual sensitivity to anesthetics and analgesics, as well as variability in stress response and pain perception. Such a design enhances the internal validity of the study and enables a more reliable interpretation of the results.",[27,28,29,30,31,32],"Cleft Lip Palate","Orofacial Cleft","Agitation, Emergence","Analgesia Assessment","Analgesia","Pediatric",[34],"Anesthesia, orofacial clefts, pain control, emergence agitation","RECRUITING","2026-04-22",{"date":38,"type":39},"2026-04-29","ACTUAL",{"date":41,"type":39},"2024-05-16",{"date":43,"type":21},"2026-09-30",{"name":45,"class":46},"Iva Smiljanić","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":47},"100616439","phase-3-safety-and-efficacy-of-bone-bioengineering-kit-with-stem-cells-for-alveolar-cleft-repair-100616439","NCT07305623","Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair","Phase III Randomized Clinical Trial on the Use of a Bone Bioengineering Kit With Stem Cells Versus Autogenous Iliac Crest Graft for Alveolar Cleft Repair in Patients With Cleft Lip and Palate","Inclusion Criteria:\n\n* Signed Informed Consent Form (ICF) from the legal guardian;\n* Signed Assent Form from the participant;\n* Patients aged 6 to 11 years at the time of the secondary bone graft surgery;\n* Participants diagnosed with unilateral cleft lip and palate of the pre-foramen incisive or transforamen type;\n* Patients must have had mesenchymal stem cells derived from deciduous teeth collected and stored in a biobank prior to signing the Informed Consent Form (ICF);\n* Patients with the maxilla previously aligned through orthodontic treatment and deemed suitable for the alveolar bone graft procedure;\n* Patients who are reliable and willing to be available throughout the study, attend all required study visits, and are willing and able to comply with study procedures as necessary.\n\nExclusion Criteria:\n\n* Previous surgery for alveolar cleft repair;\n* Presence of comorbidities (diabetes, cardiac conditions, hypertension) or allergies to latex gloves and suture materials (Catgut, Vicryl, Monocryl, Nylon, Polyester, or Polypropylene);\n* Presence of palatal fistulas resulting from previous surgeries;\n* Incomplete orthodontic or tomography documentation;\n* Eruption of the permanent canine prior to signing the Informed Consent Form (ICF) and Assent Form (AF), and prior to undergoing the secondary alveolar bone graft surgery;\n* Participants who are pregnant or breastfeeding at the time of screening or during the study.","6 Years","11 Years",{"count":58,"type":21},205,[60],"PHASE3","The objective of this study is to compare the safety and efficacy of the bone tissue engineering kit-composed of 10⁶ mesenchymal stem cells derived from deciduous dental pulp combined with a collagen- and hydroxyapatite-based biomaterial-with secondary autogenous bone grafting for alveolar cleft closure in patients with cleft lip and palate.\n\nIndividuals aged 6 to 11 years with unilateral pre- and transforamen cleft lip and palate who have an indication for bone grafting will be included.\n\nThe study will be conducted in two stages. In Stage 1, patients will undergo surgery using only the bioengineering kit, and the primary outcome will be the average length of hospital stay after grafting with the engineering kit. In Stage 2, patients will be randomized to receive either the bioengineering kit treatment or the standard iliac crest bone graft surgery. In this stage, the primary outcome will be the success rate of the cleft lip and palate repair surgery, determined by the amount of bone formation in the alveolar cleft region, measured through volumetric analyses of computed tomography scans performed 12 months after grafting.",[27],[64,65],"bioengineering kit","Stem cells","NOT_YET_RECRUITING","2025-12-12",{"date":69,"type":39},"2025-12-26",{"date":71,"type":21},"2026-07",{"date":73,"type":21},"2027-12",{"name":75,"class":46},"Instituto de Tecnologia do Paraná",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":16,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":87,"conditions":88,"keywords":95,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":47},"100609847","early-intervention-in-infants-with-unrepaired-cleft-palate-language-palatal-function-and-articulation-100609847","NCT07219901","Early Intervention in Infants With Unrepaired Cleft Palate: Language, Palatal Function, and Articulation.","Inclusion Criteria:\n\n* Infants with unrepaired cleft palate (with or without cleft lip)\n* Aged between 6 and 10 months at the time of study commencement\n\nExclusion Criteria:\n\n* Medically fragile status that would preclude participation in this community-based study.\n* Palatoplasty completed.\n* Aged over one year\n* Infants with cleft lip only","6 Months","12 Months",{"count":85,"type":21},200,[24],"The goal of this clinical trial is to learn if teaching speech skills to infants with cleft palates, prior to palate repair, will help them to develop speech and language skills. It will also learn about whether the skills are linked to fewer speech sound difficulties when they start school. The main questions it aims to answer are:\n\nDo standard, early intervention techniques to promote language development, that are used in children who are late talkers, work in infants with cleft palates? Will infants with cleft palates increase the number of sounds they use after targeted intervention? Can infants attempt to make stop sounds, like b and p, after targeted intervention? Can infants with cleft palate learn new words more quickly when they are used with gestures?\n\nParticipants will:\n\nParticipate in a baseline evaluation of speech and language skills, either in person, or via Telehealth.\n\nAttend the clinic for twice-weekly visits, for six weeks, to learn techniques to help their infants develop their speech and language skills, in a group setting with other families of infants with cleft palate.\n\nParticipate in a final evaluation of speech and language skills, either in person, or via Telehealth.",[89,27,90,91,92,93,94],"Cleft Lip and Cleft Palate","Cleft Lip and\u002For Palate","Cleft Palate","Cleft Palate Children","Cleft Palates","Cleft Palate Repair",[96,97,98,99,100,101,102,103,104],"cleft-type speech","hypernasality","palatal function","compensatory speech patterns","obligatory speech patterns","velopharyngeal dysfunction","communication","language","speech","2025-10-20",{"date":107,"type":39},"2025-10-22",{"date":109,"type":21},"2025-10-21",{"date":111,"type":21},"2027-01-31",{"name":113,"class":46},"Old Dominion University",{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":16,"minAge":122,"maxAge":82,"enrollmentInfo":123,"targetDuration":4,"studyType":22,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":140},"100590649","clinical-application-of-artificial-intelligence-in-new-borns-with-cleft-lip-and-palate-100590649","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","1 Day",{"count":124,"type":21},70,[24],"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",[128,27],"Congenital Disorder",[130,27],"artificial intelligence","2025-05-13",{"date":133,"type":39},"2025-05-16",{"date":135,"type":39},"2023-08-01",{"date":137,"type":21},"2025-12-31",{"name":139,"class":46},"University Hospital, Basel, Switzerland",2,{"id":142,"slug":143,"hasResults":11,"nctId":144,"briefTitle":145,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":147,"maxAge":148,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":152,"conditions":153,"keywords":156,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":4},"100581583","time-and-type-dependent-evaluation-of-different-techniques-for-correction-of-cleft-maxillary-hypoplasia-100581583","NCT06852196","Time and Type Dependent Evaluation of Different Techniques for Correction of Cleft Maxillary Hypoplasia","Inclusion Criteria:\n\n* Cleft patients either cleft alveolus or cleft alveolus and palate.\n* Surgically fit patients.\n* Patients ready for orthognathic assessment undergoing either surgical or orthodontics correction.\n\nExclusion Criteria:\n\n* Non- cleft cases .\n* Previous correction.\n* History of active infection or underlying disease such as hematologic disorders neoplasm, and immune deficiency.\n* Patient refused to sign an informed consent.","12 Years","40 Years",{"count":150,"type":21},22,[24],"Maxillary hypoplasia in CLP deformities results from congenital reduction in midfacial growth and the effects of the surgical scar from CLP repair.Turvey et al. suggested that this disproportionate jaw growth is the biologic consequence of prior surgical intervention for closure of the soft tissues and is not related to the congenital cleft deformity, Midfacial hypoplasia is commonly treated by performing conventional Le Fort surgery to displace the maxilla anteriorly and stabilization afterward with rigid fixation along with orthodontics treatment. .\n\nMidface hypoplasia cleft patient has the following characteristics: concave facial profile, inverted nasal tip, wide alar base, acute nasolabial angle, and excessive exposure of sclera. Intraoral findings are anterior and posterior crossbite, CLP, accentuated curve of Spee, Class III dental malocclusion, multiple missing teeth, oronasal communication, and residual cleft. Speech disturbances are also usually present due to velopharyngeal incompetency and oronasal communication.",[154,27,155],"Maxillary Hypoplasia","Orthognathic Surgery",[157],"cleft maxillary hypoplasia","2025-02-26",{"date":160,"type":39},"2025-02-28",{"date":162,"type":21},"2025-02-21",{"date":164,"type":21},"2026-12-01",{"name":166,"class":46},"Assiut University"]