Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 11:14 AM
Study NCT ID:
NCT07379632
Status:
RECRUITING
Last Update Posted:
2026-01-30
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment Effects of Vertical Holding Appliance in Comparison to Zachrisson Transpalatal Arch on Anterior Open Bite Correction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 38}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vertical skeletal measurements using cephalometric analysis', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Overbite reduction', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anterior Open Bite in Mixed Dentition']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the treatment effects of ZTPA versus VHA in the correction of anterior open bite in mixed dentition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children with the age rage from 6-12 years old.\n2. Both male and female.\n3. Class I and II skeletal and dental.\n4. Skeletal anterior open bite.\n5. Maxillary and mandibular incisors and upper first molars erupted.\n6. Good oral hygiene.\n\nExclusion Criteria:\n\n1. Systemic disease.\n2. Missing teeth.\n3. Previous orthodontic treatment.\n4. Presence of posterior crossbites.'}, 'identificationModule': {'nctId': 'NCT07379632', 'briefTitle': 'Treatment Effects of Vertical Holding Appliance in Comparison to Zachrisson Transpalatal Arch on Anterior Open Bite Correction', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Treatment Effects of Vertical Holding Appliance in Comparison to Zachrisson Transpalatal Arch on Anterior Open Bite Correction During Mixed Dentition: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '3-3-4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'vertical holding appliance', 'description': 'a transpalatal arch with acrylic button', 'interventionNames': ['Device: Vertical holding appliance']}, {'type': 'EXPERIMENTAL', 'label': 'Zachrisson transpalatal arch', 'description': 'a transpalatal arch with 2 posterior loops and 1 anterior loop', 'interventionNames': ['Device: Zachrisson transpalatal arch']}], 'interventions': [{'name': 'Zachrisson transpalatal arch', 'type': 'DEVICE', 'description': 'transpalatal arch with 2 posterior loops and 1 anterior loop', 'armGroupLabels': ['Zachrisson transpalatal arch']}, {'name': 'Vertical holding appliance', 'type': 'DEVICE', 'description': 'transpalatal arch with arcylic button', 'armGroupLabels': ['vertical holding appliance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Faculty of Dentistry Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'ola a yehia, master', 'role': 'CONTACT', 'email': 'ola.alaa@dentistry.cu.edu.eg', 'phone': '01015618886'}, {'name': 'yomna a yehia, master', 'role': 'CONTACT', 'email': 'yomna.alaa@dentistry.cu.edu.eg', 'phone': '01001459692'}], 'overallOfficials': [{'name': 'ola a yehia, master student', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Master student', 'investigatorFullName': 'Ola Alaa Yehia', 'investigatorAffiliation': 'Cairo University'}}}}