Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-01-03 @ 10:22 PM
Study NCT ID:
NCT03286569
Status:
RECRUITING
Last Update Posted:
2024-11-05
First Post:
2015-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057887', 'term': 'Overbite'}], 'ancestors': [{'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}, {'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-03', 'studyFirstSubmitDate': '2015-04-12', 'studyFirstSubmitQcDate': '2017-09-13', 'lastUpdatePostDateStruct': {'date': '2024-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lower jaw size', 'timeFrame': '9 months', 'description': 'Lower jaw size will be evaluated by computed tomography.'}, {'measure': 'Lower jaw projection', 'timeFrame': '9 months', 'description': 'Lower jaw projection will be evaluated by computed tomography.'}], 'secondaryOutcomes': [{'measure': 'Jaw joint size', 'timeFrame': '9 months', 'description': 'Jaw joint size will be evaluated by CBCT'}, {'measure': 'Base of skull bone size', 'timeFrame': '9 months', 'description': 'Base of skull bone size will be evaluated by CBCT'}, {'measure': 'Base of skull bone position', 'timeFrame': '9 months', 'description': 'Base of skull bone positions will be evaluated by CBCT'}, {'measure': 'Jaw joint position', 'timeFrame': '9 months', 'description': 'Jaw joint will be evaluated by CBCT'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Overbite (Excessive) Horizontal']}, 'referencesModule': {'references': [{'pmid': '19905846', 'type': 'RESULT', 'citation': 'McNamara JA Jr, Sigler LM, Franchi L, Guest SS, Baccetti T. Changes in occlusal relationships in mixed dentition patients treated with rapid maxillary expansion. A prospective clinical study. Angle Orthod. 2010 Mar;80(2):230-8. doi: 10.2319/040309-192.1.'}, {'pmid': '21055598', 'type': 'RESULT', 'citation': 'Guest SS, McNamara JA Jr, Baccetti T, Franchi L. Improving Class II malocclusion as a side-effect of rapid maxillary expansion: a prospective clinical study. Am J Orthod Dentofacial Orthop. 2010 Nov;138(5):582-91. doi: 10.1016/j.ajodo.2008.12.026.'}]}, 'descriptionModule': {'briefSummary': 'Young children with backward positioned lower jaw/chin will be recruited to have an upper jaw expansion appliance. Previous research showed that the use of similar appliances can lead to lower jaw forward growth. 60 young children aged 9-11 will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.', 'detailedDescription': 'Previous research showed that the use of upper jaw expansion appliances can lead to lower jaw forward growth (1). 60 young children aged 9-11 with backward positioned lower jaw/chin will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Class II skeletal due to lower jaw backward projection\n2. Class II malocclusion\n3. Early mixed dentition (all first permanent molars erupted, as well as all erupting upper and lower permanent incisors)\n\nExclusion Criteria:\n\n1. Other orthodontic treatment provided\n2. Growth problems (craniofacial syndromes, etc.)'}, 'identificationModule': {'nctId': 'NCT03286569', 'briefTitle': 'Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth', 'organization': {'class': 'OTHER', 'fullName': 'University of Alberta'}, 'officialTitle': 'Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth', 'orgStudyIdInfo': {'id': 'Pro00001731'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active upper Wilson appliance', 'description': 'Active upper arch Wilson quadhelex appliance', 'interventionNames': ['Device: Upper arch Wilson quadhelex appliance']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non active upper expansion appliance', 'description': 'Non-Active upper arch Wilson quadhelex appliance', 'interventionNames': ['Device: Upper arch Wilson quadhelex appliance']}], 'interventions': [{'name': 'Upper arch Wilson quadhelex appliance', 'type': 'DEVICE', 'description': 'Upper arch Wilson quadhelex appliance', 'armGroupLabels': ['Active upper Wilson appliance', 'Non active upper expansion appliance']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2R3', 'city': 'Edmonton', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Tarek El-Bialy', 'role': 'CONTACT', 'email': 'telbialy@ualberta.ca'}], 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'centralContacts': [{'name': 'Dr. Tarek El-Bialy, PhD', 'role': 'CONTACT', 'email': 'telbialy@ualberta.ca', 'phone': '780-492-2751'}, {'name': 'Rabia Njie, BDS', 'role': 'CONTACT', 'email': 'rnjie@ualberta.ca', 'phone': '780-850-8752'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}