[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cleft-lip-and-palate\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cleft-lip-and-palate":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,43,66,91,125,151,187,213,242,264,287,311,333,356,381,402,432,466],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100290817","identification-of-genetic-factors-implicated-in-orofacial-cleft-using-whole-exome-sequencing-100290817",false,"NCT03065686","Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing","Identification of Genetic Factors Implicated in Orofacial Cleft Using Whole Exome Sequencing GENEPIC","GENEPIC","Inclusion Criteria:\n\n* Subject with a NSCL\u002FP or CL\u002FP of unknown etiology,\n* national health care insurance holders\n\nExclusion Criteria:\n\n* Subject with a CL\u002FP of known etiology,\n* Subject with a NSCL\u002FP and an IRF6 mutation","ALL",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"NA","Despite significant progress made in identification on numerous genes and gene pathways critical for craniofacial development, several approaches, ie mutation screening of specific candidates, association studies and even genome-wide scans have largely failed to reveal the molecular basis of NS human clefting",[26],"Cleft Lip and Palate",[26,28,29],"CL\u002FP","WES","RECRUITING","2026-05-12",{"date":33,"type":34},"2026-05-13","ACTUAL",{"date":36,"type":34},"2016-11-30",{"date":38,"type":20},"2027-11-30",{"name":40,"class":41},"Centre Hospitalier Universitaire, Amiens","OTHER",1,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":58,"startDateStruct":60,"completionDateStruct":62,"leadSponsor":64,"locationsCount":42},"100421696","phase-4-ketorolac-in-palatoplasty-100421696","NCT04771156","Ketorolac in Palatoplasty","Ketorolac in Palatoplasty: A Randomized Blinded Controlled Trial.","Inclusion Criteria:\n\n-Patient with Cleft palate (Complete and incomplete), with or without cleft lip, unilateral or bilateral\n\nExclusion Criteria:\n\n* Syndromic Cleft Palate patients\n* Previous palatoplasty\n* Major unrepaired cardiac malformation\n* History of GI complications (GI Bleed, Gastric Ulceration)\n* History of Renal disorder\n* History of coagulopathy (As contraindication to NSAID use)\n* Feeding tube dependency\n* Patients whose parents refuse to consent to randomization","6 Months",{"count":52,"type":20},74,[54],"PHASE4","The purpose of this study is to see if the addition of IV Ketorolac to usual care multi-modal pain therapy compared to usual care will improve oral intake post-operatively",[26],"2026-02-17",{"date":59,"type":34},"2026-02-19",{"date":61,"type":34},"2021-09-17",{"date":63,"type":20},"2027-04-01",{"name":65,"class":41},"The University of Texas Health Science Center, Houston",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":17,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":80,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":57,"lastUpdatePostDateStruct":85,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":42},"100380544","phase-4-cost-effectiveness-in-alveolar-bone-grafting-in-patients-with-cleft-lip-and-palate-100380544","NCT04234971","Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate","Cost Effectiveness in Alveolar Bone Grafting in Patients With Cleft Lip and Palate: A Randomized Clinical Trial","Inclusion Criteria:\n\n* Patient with CLP(unilateral or bilateral)\n* Radiographically evident open bone defect of the alveolus\n* Dentition evaluated by orthodontist and cleared for ABG surgery\n\nExclusion Criteria:\n\n* Patients without CLP\n* Previous failed repair of alveolar cleft\n* Patients who have previously undergone successful ABG\n* Patients without an alveolar defect\n* Patients whose parents refuse to consent to randomization\n* Patients who have a syndromic CLP","6 Years","15 Years",{"count":76,"type":20},40,[54],"The purpose of this trial is to evaluate if the use of Bone Morphogenic Protein(BMP)\u002FDemineralized Bone Matrix (DBM) versus the use of autologous Iliac Crest Bone Graft (ICBG) will result in an increase in total cost effectiveness for patients undergoing alveolar bone graft (ABG) for Cleft Lip and Palate (CLP) and to see if patients who are treated with DBM\u002FBMP will have reduced post-operative pain scores,reduced operative times,and similar rates of bone healing compared to conventional ICBG.",[26],[81,82,83,84],"alveolar bone graft","Bone Morphogenic Protein","Demineralized Bone Matrix","cleft lip",{"date":59,"type":34},{"date":87,"type":34},"2021-06-14",{"date":89,"type":20},"2028-01-01",{"name":65,"class":41},{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":97,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":99,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":107,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":42},"100619083","analgosedation-with-ketamine-nalbuphine-or-dexmedetomidine-for-suture-removal-in-children-after-cleft-surgery-100619083","NCT07340008","Analgosedation With Ketamine, Nalbuphine, or Dexmedetomidine for Suture Removal in Children After Cleft Surgery","Comparison of Intramuscular Ketamine and Intranasal Nalbuphine and Dexmedetomidine for Analgosedation in Children Undergoing Suture Removal After Surgery for Congenital Clefts of the Palate, Alveolar Ridge, and Lip","KID-CLEFT","Inclusion criteria:\n\n* Age 6 months to 3 years\n* Scheduled for suture removal after surgery for congenital cleft of the palate, alveolar ridge, or lip\n* American Society of Anesthesiologists (ASA) physical status I or II\n* Written informed consent obtained from parents or legal guardians\n* Slovene-speaking family to ensure understanding and compliance\n* No contraindications to the use of study medications\n\nExclusion criteria:\n\n* Known allergy or hypersensitivity to ketamine, nalbuphine, or dexmedetomidine\n* ASA physical status greater than II\n* Significant neurological, psychiatric, or respiratory disorder\n* Active or recent upper respiratory tract infection\n* Refusal of parental or guardian consent\n* Developmental disorder affecting communication or cooperation","3 Years",{"count":101,"type":20},60,[23],"This prospective, randomized study is designed to compare the efficacy and safety of three sedative-analgesic agents-intramuscular ketamine, intranasal nalbuphine, and intranasal dexmedetomidine-for procedural sedation in children undergoing suture removal following cleft palate, alveolar ridge, or lip surgery. The study will include 60 children aged 6 months to 3 years, randomly assigned to one of three intervention groups.\n\nThe primary objectives are to compare time to achieve adequate sedation (Modified Ramsay Sedation Scale 2-3), surgeon-rated ease of surgical procedure, and time to discharge readiness (Modified Aldrete Score ≥9). Secondary outcomes include baseline child behavior, response to drug administration, depth of sedation, response to separation from parents, and parental satisfaction, as well as monitoring of perioperative complications and vital signs.\n\nAll study medications are approved and commonly used in pediatric anesthesia. The trial will be conducted using non-invasive monitoring, with intravenous access established only in case of emergency interventions. Findings from this study are expected to provide evidence to optimize pediatric sedation protocols for minor surgical procedures.",[105,26,106],"Orofacial Clefts","Alveolar Ridge Defect",[108,109,110,111,112,113,114,115],"pediatric sedation","Cleft surgery","Ketamine","Dexmedetomidine","Nalbuphine","Intranasal sedation","Intramuscular injection","Sedation in children","2026-01-05",{"date":118,"type":34},"2026-01-14",{"date":120,"type":34},"2025-09-01",{"date":122,"type":20},"2029-01",{"name":124,"class":41},"University Medical Centre Ljubljana",{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":42},"100394959","use-of-computer-aided-design-and-3d-printing-for-anesthesiology-management-in-a-pediatric-patient-with-cleft-facial-defect-100394959","NCT04422847","Use of Computer Aided Design and 3D Printing for Anesthesiology Management in a Pediatric Patient With Cleft Facial Defect","3D obturator","Inclusion Criteria:\n\n* Pediatric patients with unilateral or bilateral cleft lip and alveolus (U\u002FBCLA) or unilateral or bilateral cleft lip, alveolus and palate (total cleft; U\u002FBCLAP) who underwent primary lip reconstruction within 0-3 months of age (most often at our workplace in the neonatal period)\n* Pediatric patients with isolated cleft palate (ICP) and patients with unilateral or bilateral cleft lip, alveolus and palate (U\u002FBCLAP) who underwent primary cleft reconstruction between 6 and 18 months of age.\n\nExclusion Criteria:\n\n* unilateral or bilateral cleft lip without cleft alveolus\n* patients with genetically confirmed syndrome disability\n* orofacial cleft patients with associated congenital malformations that may affect the course of anesthesia (atresia of the choanae)\n* patients with atypical clefts of the face\n* patients with CLA, CLAP, ICP who underwent primary cleft lip reconstruction later than at 3 months of age\n* patients with CLAP and ICP who underwent primary cleft reconstruction later than at 18 months of age\n* patients with submucous cleft palate\n* patients with airways secured preoperatively\n* patients on artificial lung ventilation\n* patients with coagulopathy, thrombocytopenia\u002Fthrombocytopathy\n* patients at risk of malignant hyperthermia\n* patients for whom the consent of legal representatives to the research project has not been obtained","2 Years",{"count":134,"type":20},120,[23],"Congenital malformations of the orofacial area are the most common congenital malformations in children with an incidence of 1.8 children with orofacial cleft per 1000 healthy births in the Czech Republic. The care of children with cleft facial defects is multidisciplinary, centralized and takes place from birth to adulthood. At the University Hospital Brno, the treatment for patients with orofacial cleft is provided by the Cleft Center (CC) of the University Hospital Brno. The main specialties that form the basis of CC include plastic surgery, pediatric anesthesiology and neonatology. Patients with facial cleft defects are divided into 2 main groups based on the embryological causes of clefts: 1\u002F patients with cleft lip, jaw with or without cleft palate (total cleft) and 2\u002F patients with isolated cleft soft and hard palate. Anesthesia in children with orofacial clefts is specific not only to the age of the patients, but mainly to the cleft itself. Anesthesiology management, and especially intubation of these patients, are often difficult due to the nature of the defect with high incidence of complications such as difficult airway, desaturation, laryngospasm or bradycardia. In addition, tissue damage including soft tissue of the lip, alveolar arch, palate and nasal septum as well as skeleton of the premaxilla and nasal septum during intubation is seen in approximately 90% of patients. To facilitate intubation, improve anesthesiology management and safety of pediatric patients with orofacial cleft, we will develop an individualized protective tray from a silicone material, that will be used during intubation to cover the defect of the alveolar arch and palate. A mold for casting of a protective tray, will be created on a 3D printer on bases of 3D scan. Use of the protective tray would facilitate intubation, decrease anesthesiologic complications and protect soft and hard tissues of the cleft palate and upper jaw during intubation.",[26],[139,109,140,141],"3D print","Paediatric","Airway","2025-11-14",{"date":144,"type":34},"2025-11-17",{"date":146,"type":34},"2021-08-01",{"date":148,"type":20},"2026-12-31",{"name":150,"class":41},"Brno University Hospital",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":17,"minAge":158,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":162,"conditions":163,"keywords":171,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":186},"100475177","pact-programme-for-parents-of-children-with-shcn-100475177","NCT05467527","PACT Programme for Parents of Children With SHCN","Effectiveness of Prosocial-orientated Acceptance and Commitment Training (PACT) Programme for Parents of Children With Special Health Care Needs in Response to Outbreaks of Novel Infectious Disease: A Randomised Controlled Trial","Inclusion Criteria:\n\n* Cantonese-speaking Hong Kong residents\n* Living together with the child who is at preschool\u002Fschool-age (3-8 years old)\n* Caregivers who adopted the responsibility of taking care of the child,\n* has daily access to their iPhone and Android smartphones.\n\nIn addition, potential eligible parents who respond \"yes\" to any of the five validated screening questions in the Children with Special Health Care Needs (SHCN) Screener (see https:\u002F\u002Fwww.childhealthdata.org\u002Fdocs\u002Fcshcn\u002Ftechnical-summary-of-cshcn-screener.pdf) will then be asked the associated follow-up questions to determine whether the child possesses physical, neurodevelopmental\u002Femotional problem(s) that has lasted for at least 12 months. Only children with a positive response(s) to ≥ 1 item in each of the associated follow-up questions will be classified as children with SHCN.\n\nExclusion Criteria:\n\n* Parents who have diagnoses of severe mental illness or developmental disabilities, such as intellectual disabilities","21 Years",{"count":160,"type":20},196,[23],"This randomised controlled trial aims to determine the efficacy of a 12-week, smartphone-based Prosocial-orientated Acceptance and Commitment Training (PACT) programme plus age-appropriate positive parenting advice on the psychological flexibility, prosociality, parenting competence and family functioning with parents of children with special health care needs as well as the mental well-being of parent-child dyads over 12 months follow-up.",[164,165,166,26,167,168,169,170],"Urologic Diseases","Gastrointestinal Diseases","Vascular Diseases","Neurodevelopmental Disorders","Attention Deficit Hyperactivity Disorder","Autism Spectrum Disorder","Developmental Delay",[172,173,174,175,176],"Acceptance and Commitment Therapy","Randomised Controlled Trial","Special health care needs","novel infectious disease","prosociality","2025-08-08",{"date":179,"type":34},"2025-08-13",{"date":181,"type":34},"2022-06-27",{"date":183,"type":20},"2025-12-31",{"name":185,"class":41},"Chinese University of Hong Kong",2,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":73,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":21,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":42},"100592540","evaluation-of-maxillary-expansion-using-clear-aligners-therapy-in-patients-with-cleft-lip-and-palate-at-the-mixed-dentition-stage-100592540","NCT06994754","Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage","Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Pilot Study","Pilot","Inclusion Criteria:\n\n* Mixed dentition.\n* Both males and females.\n* Bilateral cleft lip and palate.\n* Lip repair performed between 3 and 6 months of age and palate repair performed between 12and 24 months of age.\n* Presence of maxillary constriction that needs maxillary expansion.\n* Good periodontal health.\n* No previous orthodontic treatment.\n\nExclusion Criteria:\n\n* Syndromic cleft lip and palate patients.\n* Taking medications that influence growth.","12 Years",{"count":197,"type":20},10,[23],"The goal of this clinical trial is to learn if the aligners can expand upper dental arch in patients with cleft lip and palate at age of 6-8 years old to correct their collapsid archs. The main questions it aims to answer are:\n\nDoes aligners can achieve transverse dento-skeletal changes? Does aligners can achieve anteroposterior and vertical dento-skeletal changes?\n\nParticipants will:\n\nWear sequence of aligners (each for 10 days). Visit the clinic every month for checkups. 3D x-ray and intraoral scan will be taken after completion of the aligners set to evaluate the intervention.",[201,26],"Maxillary Deficiency",[203],"Maxillary Expansion by Aligners","2025-06-09",{"date":206,"type":34},"2025-06-12",{"date":208,"type":34},"2025-04-06",{"date":210,"type":20},"2026-12",{"name":212,"class":41},"Cairo University",{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":219,"maxAge":195,"enrollmentInfo":220,"targetDuration":222,"studyType":223,"phases":4,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":42},"100584902","high-and-low-intensity-speech-intervention-in-children-with-a-cleft-palate-perceptions-of-children-their-caregivers-and-speech-language-pathologists-100584902","NCT06895395","High and Low Intensity Speech Intervention in Children With a Cleft Palate: Perceptions of Children, Their Caregivers and Speech-language Pathologists","Inclusion Criteria:\n\n* Belgian Dutch-speaking children with a cleft palate with or without a cleft lip\n* Aged between 4 and 12 years,\n* Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist\n\nExclusion Criteria:\n\n* Children with syndromic clefts\n* Oronasal fistula\n* Velopharyngeal insufficiency\n* Hearing disabilities based on pure tone audiometry (\\>25 dB HL)\n* Cognitive and\u002For related learning disabilities or neuromuscular disorders","4 Years",{"count":221,"type":20},175,"1 Month","OBSERVATIONAL","A cleft (lip and) palate (CP±L) is the most common congenital abnormality of the face and skull with a significant social impact, affecting speech, hearing, feeding, oral behavior, dentition and satisfaction with appearance. These consequences have a long-term and negative impact on social integration and well-being. The World Health Organization (WHO) highlights the significant financial costs, including morbidity, health care costs, emotional distress and social exclusion for patients, their families and society. The purpose of this study is to compare high- and low-intensity speech intervention in children with CP±L based on the perceptions of the providers of the intervention (primary care speech-language pathologists) and the recipients of the intervention (children with CP±L and their caregivers). Individual semi-structured interviews will be conducted with both intervention providers and recipients to explore perceptions and experiences, as well as acceptability of the two speech intervention intensities. Potential participants will be told that the interview will be recorded. The actual interviews will take place at a location and time that is most convenient for the participants. Each interview will be recorded using a Roland R-05 high-quality audio recorder. After conducting the interviews, all participants will be asked to complete a questionnaire regarding their demographics. In addition, data regarding the type of cleft, time and manner of closure of the cleft, any secondary surgery and otological\u002Faudiological data will be collected from the medical records of the children with CP±L. Based on this qualitative study, possible adjustments to the high-intensity therapy protocol can be made. In doing so, these modifications will be relevant to these key stakeholders. This will also facilitate the implementation and widespread use of high-intensity speech therapy in clinical speech therapy practice.",[26,226],"Speech Disorders in Children",[228,229,230,231,232],"Cleft lip and palate","Qualitative research","Speech therapy","Interviews","Speech intervention intensity","2025-03-25",{"date":235,"type":34},"2025-03-26",{"date":237,"type":20},"2025-05-01",{"date":239,"type":20},"2027-12",{"name":241,"class":41},"University Ghent",{"id":243,"slug":244,"hasResults":11,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":218,"healthyVolunteers":11,"sex":17,"minAge":219,"maxAge":195,"enrollmentInfo":248,"targetDuration":4,"studyType":21,"phases":250,"briefSummary":251,"conditions":252,"keywords":255,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":263,"locationsCount":42},"100545423","effect-and-cost-utility-of-of-high-intensity-vs-low-intensity-speech-intervention-in-children-with-cleft-palate-100545423","NCT06381713","Effect and Cost-utility of of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate","Short and Long Term Effect and Cost-utility of High Intensity vs. Low Intensity Speech Intervention in Children With Cleft Palate",{"count":249,"type":20},70,[23],"Achieving speech that is understandable and acceptable to others is the key outcome in cleft treatment. Therefore, speech therapy provided by a speech-language pathologist is necessary. This intervention is traditionally provided twice per week for 30 minutes for months or even years by first-line speech-language pathologists. Unfortunately, this low intensity intervention is based on a historical context rather than scientific evidence. This means that current speech therapy knows several shortcomings including poor outcomes, treatment fatigue and high costs related to year-long therapy. Because of these issues, the use of high intensity speech intervention is proposed. Even though solid proof-of-concepts exist for this model, it has not yet found its way into clinical practice.\n\nBefore this intensity can be implemented and utilized in clinical practice, the effect of this novel program on a larger societal scale must be determined. This project will compare the effect of high intensity and low intensity speech intervention in children with a cleft palate in terms of speech, quality of life, and cost-utility as provided by first-line speech-language pathologists by conducting a large-scale randomized controlled trial. The final goal is to utilize this program in clinical practice and to create awareness of the benefits for children with a cleft palate among stakeholders.",[253,254,226,26],"Cleft Palate Children","Speech Therapy",[256,230,228],"Randomized controlled trial","2025-01-09",{"date":259,"type":34},"2025-01-13",{"date":261,"type":34},"2024-11-26",{"date":239,"type":20},{"name":241,"class":41},{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":270,"sex":17,"minAge":271,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":21,"phases":274,"briefSummary":275,"conditions":276,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":42},"100555345","single-stage-versus-multiple-staged-repair-of-nasal--alveolar-deformities-in-patients-with-cleft-lip-and-palate-100555345","NCT06510881","Single Stage Versus Multiple Staged Repair of Nasal & Alveolar Deformities in Patients With Cleft Lip and Palate","Inclusion Criteria:\n\n\\- Patients with unilateral cleft lip and palate deformities with evident nasal and cleft lip and palate aged between 5 - 18 years.\n\nExclusion Criteria:\n\n* \\* Patients with bilateral complete cleft palate .\n\n  * Patients with only cleft lip.\n  * Patients with cleft secondary palate.\n  * Patients non fit for surgery.\n  * Patients refuse the consent.",true,"5 Years","18 Years",{"count":76,"type":20},[23],"Cleft lip and palate patients are commonly seen among maxillofacial patients. Patients with cleft lip and palate have evident cosmetic nasal deformities. The interrupted insertion of orbicularis oris muscle into the columella on the noncleft side forces the premaxilla, columella and caudal nasal septum towards that side. At the same time, as the orbicularis oris inserts into the alar base on the cleft side, the base is pulled laterally, inferiorly and posteriorly. The malformed lower lateral cartilage on the side of the cleft contributes majorly to the deformity of the nasal tip, causing it to be more blunt. A shorter medial crus and longer lateral crus on the cleft side results in a horizontally wider and displaced nostril on the cleft side. In addition, those patients have alveolar bone defect which results in both cosmetic and dental problems. Repair of the deformed nose along with the reconstruction of the alveolar defect may have an advantage over the staged repair in:- decrease the surgical burden on the patient , correction of the facial asymmetry by redeeming the maxillary bony support , peri-alar augmentation and accordingly obtaining faster and better socio-cosmetic benefit .",[26,277],"Rhinoplasty","2024-07-18",{"date":280,"type":34},"2024-07-19",{"date":282,"type":20},"2024-07-20",{"date":284,"type":20},"2027-02-20",{"name":286,"class":41},"Assiut University",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":11,"sex":17,"minAge":73,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":21,"phases":294,"briefSummary":296,"conditions":297,"keywords":298,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":42},"100537946","phase-3-liposomal-bupivacaine-use-in-alveolar-bone-graft-patients-100537946","NCT06284434","Liposomal Bupivacaine Use in Alveolar Bone Graft Patients","Inclusion Criteria:\n\n* Patients that are 6 and older who have a diagnosis of cleft lip and\u002For palate with a scheduled surgery that involves an alveolar bone graft.\n\nExclusion Criteria:\n\n* Patients under age 6 are excluded from this study as EXPAREL® is not FDA approved for this group.\n* Patients with a history of allergic or adverse reaction to any drug involved in the study (EXPAREL, Epinephrine, or Bupivacaine).\n* Patients with a history of cardiovascular disease.",{"count":101,"type":20},[295],"PHASE3","The goal of this clinical trial is to learn if a pain medication called liposomal bupivacaine (brand name EXPAREL®) with epinephrine will provide better pain control, increased activity, and reduced use of opioids compared with the standard treatment for patients age 6 years and older with cleft lip and palate who have had an alveolar bone graft surgery. Investigators will look at:\n\n* pain scores at hip and jaw sites\n* opioid use in amount and frequency\n* scores on activity questionnaires Researchers will compare the results of these items with those of patients who had the standard treatment of bupivacaine with epinephrine.",[26],[84,299,81,300,301],"cleft palate","pain management","liposomal bupivacaine","2024-07-02",{"date":304,"type":34},"2024-07-03",{"date":306,"type":34},"2024-04-24",{"date":308,"type":20},"2026-04-24",{"name":310,"class":41},"Kerry O'Rourke",{"id":312,"slug":313,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":270,"sex":17,"minAge":318,"maxAge":319,"enrollmentInfo":320,"targetDuration":4,"studyType":21,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":324,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":329,"leadSponsor":331,"locationsCount":186},"100550761","the-effectiveness-of-adhesive-versus-conventional-nasoalveolar-molding-on-children-with-unilateral-cleft-lip-and-palate-100550761","NCT06451276","The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate","The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Alveolar Ridge, Nasal and Labial Growths in Children With Unilateral Cleft Lip and Palate","Inclusion Criteria:\n\n* Age: 1- 8 weeks.\n* Gender: male and female.\n* Patients with a unilateral cleft alveolus and lip.\n* No developmental syndromes or atypical cleft pathology in medical history.\n* No previous history of unilateral CLP correction.\n* Motivated parents toward the treatment.\n\nExclusion Criteria:\n\n* Patients with a bilateral cleft alveolus and lip\n* Syndromic patient\n* Uncooperative caregiver","7 Days","12 Weeks",{"count":19,"type":20},[23],"The present study will compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate.\n\nobjectives: -\n\n1. Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point.\n2. Evaluation of the nasal symmetry.",[26],"NOT_YET_RECRUITING","2024-06-10",{"date":327,"type":34},"2024-06-11",{"date":282,"type":20},{"date":330,"type":20},"2025-08-20",{"name":332,"class":41},"Al-Azhar University",{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":270,"sex":17,"minAge":73,"maxAge":340,"enrollmentInfo":341,"targetDuration":4,"studyType":21,"phases":343,"briefSummary":344,"conditions":345,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":348,"lastUpdatePostDateStruct":349,"startDateStruct":351,"completionDateStruct":353,"leadSponsor":354,"locationsCount":42},"100525520","effectiveness-of-dual-light-electric-toothbrush-vs-manual-toothbrush-in-orthodontic-patients-undergoing-oral-surgery-100525520","NCT06122805","Effectiveness of Dual Light Electric Toothbrush vs. Manual Toothbrush in Orthodontic Patients Undergoing Oral Surgery","Effectiveness of Dual Light Therapy Electric Toothbrush vs.Manual Toothbrush on Periodontal Health of Orthodontic Patients Undergoing Oral Surgery","Inclusion Criteria:\n\n* Patient of record of the Craniofacial and Special Care Orthodontic Clinic at Children's Hospital Los Angeles\n* Between the ages of 6 and 20 years\n* Physical status of ASA I or II\n* Diagnosis of craniofacial and\u002For isolated, complete or incomplete, bilateral or unilateral cleft lip and palate\n\nExclusion Criteria:\n\n* physical inability to brush teeth\n* cognitive inability to comprehend and follow directions.","20 Years",{"count":342,"type":20},198,[23],"The study is a randomized clinical trial to compare the effectiveness of a dual light ultrasonic toothbrush on periodontal health in orthodontic patients undergoing surgery.\n\nPatients with cleft lip and palate undergo bone graft and orthognathic surgery. The study will compare the periodontal outcomes in patients who use these toothbrushes during the post-surgical period.",[346,347,26],"Toothbrushing","Gingivitis","2024-05-09",{"date":350,"type":34},"2024-05-13",{"date":352,"type":34},"2024-03-11",{"date":38,"type":20},{"name":355,"class":41},"Children's Hospital Los Angeles",{"id":357,"slug":358,"hasResults":11,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":11,"sex":17,"minAge":363,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":370,"conditions":371,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":42},"100547466","phase-1-phase-i-iia-to-evaluate-the-safety-feasibility-and-efficacy-of-the-use-of-biocleft-in-the-treatment-of-cleft-palate-100547466","NCT06408337","Phase I-IIa, to Evaluate the Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Cleft Palate.","Phase I-IIa, Randomized, Controlled, Open-label, Single-center Clinical Trial to Evaluate Safety, Feasibility, and Efficacy of the Use of BIOCLEFT in the Treatment of Patients With Cleft Palate","Inclusion Criteria:\n\n* Pediatric patients, of both sexes.\n* Diagnosis of total unilateral non-syndromic cleft lip and palate (FLPNS) that will undergo surgery for correction.\n* Children who have previously donated a sample of oral mucosa during the cleft lip repair procedure (cheiloplasty).\n* Informed consent signed by one or both parents (or legal guardian) adequately informed of the study and willing to follow the trial procedures and instructions.\n\nExclusion Criteria:\n\n* Active infectious diseases.\n* Allergies or hypersensitivity to any of the components\u002Fexcipients of the Investigational Product.\n* Severe hematological disorders\u002Fblood dyscrasias.\n* Severe hepatic or renal dysfunction\u002Ffailure.\n* Serious endocrine disorders\u002Fdysfunctions.\n* Malignant neoplasms\n* Active HIV, HBV or HCV infection.\n* Metabolic bone diseases (Paget's disease, hypercalcemia, etc.).\n* Children with cleft lip and palate who present other congenital malformations that, in the opinion of the researcher, could affect the result of the study or the interpretation of the results of the study.\n* Any other pathology that in the opinion of the investigator should not be included in the study for other medical or social reasons.","10 Months","14 Months",{"count":366,"type":20},15,[368,369],"PHASE1","PHASE2","Phase I\u002FII, controlled, open-label, randomized, single site clinical trial to assess the safety and feasibility, as well as hint efficacy evidence of a bioengineered palate mucosa substitute on nanostructured fibrin-agarose scaffolds with autologous mucosa tissue-specific cells (culture-expanded fibroblasts and keratinocytes), for tissue replacement and repair of donor area after the reconstruction of palate cleft defects (staphylorraphy), in comparison with standard care for donor mucosa.",[26],"2024-05-06",{"date":374,"type":34},"2024-05-10",{"date":376,"type":34},"2024-04-17",{"date":378,"type":20},"2028-12-17",{"name":380,"class":41},"Elisa María Cubiles Montero de Espinosa",{"id":382,"slug":383,"hasResults":11,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":11,"sex":17,"minAge":219,"maxAge":195,"enrollmentInfo":388,"targetDuration":4,"studyType":21,"phases":390,"briefSummary":391,"conditions":392,"keywords":393,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":399,"leadSponsor":401,"locationsCount":42},"100524159","effect-of-performance-specific-cleft-speech-intervention-and-long-term-learning-in-children-with-a-cleft-palate-100524159","NCT06105099","Effect of Performance-specific Cleft Speech Intervention and Long-term Learning in Children With a Cleft Palate","One Size Does Not Fit All: From a Common Approach Towards Performance-specific Speech Intervention and Long-term Learning in Children With a Cleft Palate","Inclusion Criteria:\n\n* Belgian Dutch-speaking children with a cleft palate with or without a cleft lip\n* Aged between 4 and 12 years\n* Presence of at least one compensatory speech error in their speech based on the perceptual assessment of one experienced speech-language pathologist\n\nExclusion Criteria:\n\n* Children with syndromic clefts\n* Oronasal fistula\n* Velopharyngeal insufficiency\n* Hearing disabilities based on pure tone audiometry (\\>25 dB HL)\n* Cognitive and\u002For related learning disabilities or neuromuscular disorders",{"count":389,"type":20},135,[23],"Speech therapy in children with a palate deals with two scientific challenges that will be addressed in this project.\n\nThe first challenge is selecting the best speech approach for a child with a specific cleft speech characteristic (CSC). Many speech therapists use a 'one-size-fits-all' approach to treat compensatory CSCs resulting in poor short- and long-term speech outcomes. To increase the effectiveness and quality of cleft speech care, it is necessary to find the best match between a specific therapy and a given type of CSC. Therefore, this proposal will compare the effect of 3 different speech approaches on the speech and quality of life in Dutch speaking children with different types of CSCs.\n\nThe second challenge is selecting the best speech approach to enhance long-term learning and transfer of newly established speech skills to untrained consonants. To date, research mainly focused on immediate therapy effects. It is unknown if permanent speech changes occur. Hence, this project will also investigate the short-term and long-term learning effects (retention and transfer) of the different speech approaches from the first objective.\n\nThis proposal will improve evidence-based and patient-tailored cleft speech therapy.",[253,226,26,254],[256,230,228],"2023-10-23",{"date":396,"type":34},"2023-10-27",{"date":398,"type":34},"2022-10-01",{"date":400,"type":20},"2026-09-30",{"name":241,"class":41},{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":270,"sex":17,"minAge":409,"maxAge":410,"enrollmentInfo":411,"targetDuration":413,"studyType":223,"phases":4,"briefSummary":414,"conditions":415,"keywords":416,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":422,"lastUpdatePostDateStruct":423,"startDateStruct":425,"completionDateStruct":427,"leadSponsor":429,"locationsCount":42},"100498855","test-retest-reliability-responsiveness-and-interpretability-of-cleft-q-100498855","NCT05775679","Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q","CLEFT-QSwePsyc","Inclusion Criteria:\n\n* Cleft lip and\u002For palate\n* Planned secondary surgery of the nose, lips, jaw or to improve speech\n* Can speak and read Swedish\n\nExclusion Criteria:\n\n* Multiple surgeries at once","8 Years","29 Years",{"count":412,"type":20},260,"1 Year","The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and\u002For palate. The main questions it aims to answer are:\n\n1. Are CLEFT-Q scores reliable over time?\n2. Can CLEFT-Q detect change following surgical treatment intervention?\n3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and\u002For palate?\n4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and\u002For palate?\n5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?\n6. What are the main expectations that patients express before a surgical intervention?\n7. How do patients perceive that the results after surgical interventions meet their expectations?\n8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?\n9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?\n\nParticipants will\n\n1. Fill out the questionnaire CLEFT-Q twice with a two-week space.\n2. Before and 1 year after an operation.\n3. Be interviewed about their experiences related to an operation or using CLEFT-Q.\n\nResearchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.",[26],[417,418,419,420,421],"CLEFT-Q","Psychometrics","Test-retest reliability","Interpretability","Responsiveness","2023-03-16",{"date":424,"type":34},"2023-03-20",{"date":426,"type":34},"2022-02-15",{"date":428,"type":20},"2028-12-31",{"name":430,"class":431},"Department of Plastic and Reconstructive Surgery","NETWORK",{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":270,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":439,"targetDuration":4,"studyType":223,"phases":4,"briefSummary":441,"conditions":442,"keywords":450,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":464,"locationsCount":42},"100178744","genetics-of-reproductive-disorders-including-kallmann-syndrome-and-cleft-lip-andor-palate-100178744","NCT01601171","Genetics of Reproductive Disorders (Including Kallmann Syndrome) and Cleft Lip and\u002For Palate","The Genetics of Neuroendocrine Reproductive Disorders and of the Cleft Lip and\u002For Palate","Inclusion Criteria:(any of the following conditions)\n\n* hypogonadotropic hypogonadism\n* Kallmann syndrome\n* adult-onset hypogonadotropic hypogonadism\n* hypothalamic amenorrhea\n* polycystic ovarian syndrome\n* primary gonadal failure\n* precocious puberty\n* cleft lip\u002Fpalate\n* family members of the above groups\n\nExclusion Criteria:\n\n* acute illness\u002Fhospitalization\n* pituitary tumors\n* iron overload (hemochromatosis)\n* infiltrative diseases (sarcoidosis)\n* chronic alcohol abuse\n* illicit drug use\n* anabolic steroid abuse",{"count":440,"type":20},2000,"The purpose of this study is to explore the genetic basis of reproductive disorders and cleft lip and\u002For palate.",[443,444,445,446,447,26,448,449],"Kallmann Syndrome","Hypogonadotropic Hypogonadism","Hypothalamic Amenorrhea","Polycystic Ovarian Syndrome","Precocious Puberty","Cleft Palate","Cleft Lip",[451,452,453,454,84,299,455,456],"GnRH deficiency","hypogonadism","anosmia","infertility","cryptorchidism","microphallus","2022-06-17",{"date":459,"type":34},"2022-06-21",{"date":461,"type":4},"2012-03",{"date":463,"type":20},"2030-03",{"name":465,"class":41},"Centre Hospitalier Universitaire Vaudois",{"id":467,"slug":468,"hasResults":11,"nctId":469,"briefTitle":470,"officialTitle":471,"acronym":4,"eligibilityCriteria":472,"healthyVolunteers":270,"sex":17,"minAge":473,"maxAge":132,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":476,"briefSummary":477,"conditions":478,"keywords":480,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":42},"100445501","influence-of-presurgical-orthodontic-molding-on-the-growth-of-newborns-with-unilateral-cleft-lip-palate-100445501","NCT05081258","Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate","Influence of Presurgical Orthodontic Molding on the Growth of Newborns With Unilateral Cleft Lip Palate: a Prospective, Randomized, Clinical Trial","Inclusion Criteria:\n\n* newborns\u002Finfants with non-syndromal (ns) unilateral cleft lip palate (UCLP)\n* signed informed consent by the parents or legal guardian\n\nExclusion Criteria:\n\n* newborns\u002Finfants with syndromal (s) unilateral cleft lip palate (UCLP)\n* insufficient adherence and compliance by the parents or legal guardian\n* withdrawal of informed consent by the parents or legal guardian","1 Day",{"count":475,"type":20},34,[23],"Orofacial clefts are the second most common birth deformity and vary in etiology and phenotype, e.g. isolated cleft palate, cleft lip or cleft lip palate. Especially newborns with unilateral complete cleft lip and palate (UCLP) present severe facial asymmetries auch as a broad and flat ala of the nose, a deviation of the columella and the philtrum to the non cleft side. Since postnatal asymmetries can even remain after surgical lip closure in a alleviated shape, therapeutic presurgical orthodontic approaches to improve symmetrie of the nose and to achieve ideal conditions for lip surgery are essential.\n\nPresurgical orthodontic treatment for newborns with UCLP start within the first days after birth to separate oral and nasal cavitiy, to improve breathing and feeding and to regulate growth of the maxillary segments using passive appliances (passive Alveolar Molding (pAM)). An advanced and widely spread concept is the Nasoalveolar Molding (NAM) by Grayson, which was first introduced in 1993 as a palate plate combined with a nasal stent as a non-invasive presurgical appliance to stimulate growth of the nose and use the postnatal potential to modulate the nasal cartilage. The aim of the NAM therapy is to reduce nasal width, to reduce deviation of the columella to the non cleft side and to increase nostril height. However, due to inhomogeneous study designs and results, so far only a slightly positive effect using NAM therapy could be detected and prospective, randomized clinical trials are necessary.\n\nThe aim of the study is to analyse and to compare the effects of pAM versus NAM treatment in newborns with UCLP in the first year of life. The following parameters will be analysed on defined study time points: nostril width, nasal morphology, cleft width, maxillary growth, statical and dynamical facial asymmetries and facial perception.",[26,479],"Unilateral Cleft Lip",[481,482,483,484],"passie Alveolar Molding","Nasoalveolar Molding","Maxillary Growth","Facial Asymmetry","2022-05-17",{"date":487,"type":34},"2022-05-18",{"date":489,"type":34},"2022-05-01",{"date":491,"type":20},"2026-11-01",{"name":493,"class":41},"University of Erlangen-Nürnberg"]