Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT05331456
Status:
UNKNOWN
Last Update Posted:
2023-12-06
First Post:
2022-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alveolar Cleft Repair Using Osteoinductive Ceramics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002971', 'term': 'Cleft Lip'}, {'id': 'D002972', 'term': 'Cleft Palate'}], 'ancestors': [{'id': 'D008047', 'term': 'Lip Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D009056', 'term': 'Mouth Abnormalities'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stepped wedge cluster randomized trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bone volume', 'timeFrame': '1 year postoperatively', 'description': 'One year postoperative residual bone volume'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Day 1 to 7 postoperatively', 'description': 'Postoperative pain on a 1 to 10 scale'}, {'measure': 'Canine eruption', 'timeFrame': '1 year postoperatively', 'description': 'Eruption of the canine (or lateral incisor) adjacent to the alevolar cleft'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cleft palate', 'cleft lip', 'alveolar cleft', 'calcium phosphate ceramics', 'bone graft'], 'conditions': ['Cleft Palate Children', 'Cleft Alveolar Ridge', 'Cleft Lip and Palate']}, 'descriptionModule': {'briefSummary': 'In this study, patients with unilateral cleft lip and palate are enrolled in a multicenter stepped wedge randomized trial ithat compares alveolar cleft closure using autologous bone harvested form the mandibular symphysis with an osteoinductive biphasic calcium phosphate putty.', 'detailedDescription': "Rationale: Patients who undergo alveolar cleft grafting have to deal with postoperative pain and comorbidity due to harvesting of autologous bone.\n\nObjective: To evaluate if using calcium phosphate based scaffolds for alveolar cleft grafting is as effective as the use of an autologous bone graft.\n\nStudy design: A 'stepped wedge' randomized controlled trial will be conducted by four centres.\n\nStudy population: Children between the ages of 8 to 12 years with a unilateral alveolar cleft.\n\nIntervention: Study group undergoes alveolar cleft grafting with the use of a calcium phosphate based scaffold, the control group undergoes the same procedure, but with the use of an autologous chin bone graft.\n\nMain study parameters/endpoints: Main study outcome is one year postoperative residual bone volume in the reconstructed alveolar cleft. Secondary objectives of importance are postoperative pain and eruption of the tooth adjacent to the cleft through the reconstructed area.\n\nNature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the control group will undergo a procedure that is currently seen as the gold standard. Patients in the study group will undergo the exact same risks as the control group, except there is no risk for donor site morbidity and postoperative pain is significantly less. Postoperative clinical and radiological evaluation of both groups is according to current treatment standards."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral alveolar cleft, early secondary alveolar cleft closure\n\nExclusion Criteria:\n\n* cleft lip and palate in a syndromic context'}, 'identificationModule': {'nctId': 'NCT05331456', 'acronym': 'ACROSTIC', 'briefTitle': 'Alveolar Cleft Repair Using Osteoinductive Ceramics', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Alveolar Cleft Repair Using Osteoinductive Ceramics in Children With Unilateral Cleft Lip and Palate', 'orgStudyIdInfo': {'id': 'NL75562.041.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Alveolar cleft repair using autologous bone from the mandibular symphysis', 'description': 'Control group', 'interventionNames': ['Device: Unilateral alveolar cleft repair']}, {'type': 'OTHER', 'label': 'Alveolar cleft repair using a biphasic clacium phosphate putty', 'description': 'Study group', 'interventionNames': ['Device: Unilateral alveolar cleft repair']}], 'interventions': [{'name': 'Unilateral alveolar cleft repair', 'type': 'DEVICE', 'description': 'Early secondary alveolar cleft repair is performed in children with a unilateral alveolar cleft using eirther autologous bone or a calcium phosphate based putty', 'armGroupLabels': ['Alveolar cleft repair using a biphasic clacium phosphate putty', 'Alveolar cleft repair using autologous bone from the mandibular symphysis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Jitske Nolte, MD, DDS, PhD', 'role': 'CONTACT'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Johan Jansma, MD, DDS, PhD', 'role': 'CONTACT'}, {'name': 'Rutger Schepers, MD, DDS, PhD', 'role': 'CONTACT'}], 'facility': 'UMC Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Nijmegen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Marloes Nienhuijs, MD, DDS, PhD', 'role': 'CONTACT'}], 'facility': 'Radboud UMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Utrecht', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Nard Janssen, MD, DDS, PhD', 'role': 'CONTACT', 'email': 'n.g.janssen-2@umcutrecht.nl', 'phone': '+31887574560'}], 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'centralContacts': [{'name': 'Nard Janssen, MD, DDS, PhD', 'role': 'CONTACT', 'email': 'n.g.janssen-2@umcutrecht.nl', 'phone': '0887574560', 'phoneExt': '+31'}], 'overallOfficials': [{'name': 'Nard Janssen, MD, DDS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radboud University Medical Center', 'class': 'OTHER'}, {'name': 'Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)', 'class': 'OTHER'}, {'name': 'Academisch Ziekenhuis Groningen', 'class': 'OTHER'}, {'name': 'Medisch Centrum Leeuwarden', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'N.G. Janssen, Prinicpal Investigator', 'investigatorFullName': 'Nard Janssen', 'investigatorAffiliation': 'UMC Utrecht'}}}}