Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-26 @ 3:55 AM
Study NCT ID:
NCT07301918
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063173', 'term': 'Retrognathia'}], 'ancestors': [{'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'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'statistician'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-11-21', 'studyFirstSubmitQcDate': '2025-12-23', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain perception', 'timeFrame': 'first week after appliance insertion', 'description': 'Pain perception during the first week after insertion using Wong-Becker faces scale with minimum value of zero and maximum value of ten, ten score represents the worst pain percieved.'}], 'secondaryOutcomes': [{'measure': 'skeletal expansion', 'timeFrame': '6 months post expansion', 'description': 'skeletal expansion using Cone Beam Computed Tomography skeletal expansion: linear distances of the midpalatal suture opening measured in mm between the pre- and post-axial cuts of the CBCT'}, {'measure': 'dental tipping', 'timeFrame': '6 months post-expansion', 'description': 'Angular measurement of upper first molars angulation measured in degrees between pre- and post-coronal cuts of the CBCT'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['expander', 'maxillary transverse deficiency', 'posterior crossbite', 'mixed dentition'], 'conditions': ['Posterior Crossbite', 'Maxilla; Hypoplasia']}, 'descriptionModule': {'briefSummary': 'Design: Two-arm parallel randomized clinical trial in mixed dentition (6-12 years).\n\nArms: (1) 9 mm, 900 g leaf expander; (2) 9 mm Hyrax expander. Follow-up: From appliance insertion → completion of intended expansion → 6-month retention.\n\nPrimary outcome: Pain perception during the first 7 days post-insertion (daily patient-reported scale).\n\nSecondary outcomes: Skeletal and dental changes on CBCT.', 'detailedDescription': 'Participants receive a banded maxillary expansion appliance cemented to maxillary first permanent molars, assigned to:\n\nLeaf expander arm: Nickel-titanium leaf-spring expander, 9 mm screw, delivering force of \\~900 g.\n\nHyrax expander arm: Conventional tooth-borne jackscrew expander, 9 mm screw. Standard activation: two turns per week.\n\nRetention: Both appliances kept passively in situ for 6 months of retention following achievement of planned expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients\n* Mixed dentition stage\n* Unilateral or bilateral posterior crossbite.\n* Patients in prepubertal stage with cervical vertebral maturation stage 1-3.\n* Fully erupted maxillary and mandibular permanent first molars.\n* Skeletal class I or II.\n\nExclusion Criteria:\n\n* Previous orthodontic treatment.\n* Missing teeth.\n* Inadequate oral hygiene.\n* Patients with bad oral habits.\n* Patients with medical conditions.\n* Patients with cleft lip and palate.'}, 'identificationModule': {'nctId': 'NCT07301918', 'briefTitle': 'Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite.', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of the Effects of the Leaf Expander Versus Hyrax Expander in Mixed Dentition Patients With Posterior Crossbite: A Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': '24619942'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Banded Leaf expander supported on the maxillary first permanent molars', 'description': '9mm leaf expander delievering 900 gm force will be supported on the upper first permanent molars with the appliance arm extending to the canines', 'interventionNames': ['Device: The Leaf expander']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Banded Hyrax expander supported on the maxillary first permanent molars', 'description': '9mm Hyrax expander will be supported on the upper first permanent molars with the appliance arm extending to the canines', 'interventionNames': ['Device: Hyrax expander']}], 'interventions': [{'name': 'The Leaf expander', 'type': 'DEVICE', 'description': "The Leaf expander incorporates Nickel Titanium springs that will not require the patients' home activation", 'armGroupLabels': ['Banded Leaf expander supported on the maxillary first permanent molars']}, {'name': 'Hyrax expander', 'type': 'DEVICE', 'description': "Hyrax expander incorporates a screw that requires the patients' home activation", 'armGroupLabels': ['Banded Hyrax expander supported on the maxillary first permanent molars']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Noura Mohamed Hamza Hassan Saleh', 'investigatorAffiliation': 'Cairo University'}}}}