Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-29 @ 11:02 AM
Study NCT ID:
NCT01320657
Status:
COMPLETED
Last Update Posted:
2022-12-22
First Post:
2011-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial of Three Fixed Orthodontic Appliances
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-20', 'studyFirstSubmitDate': '2011-03-21', 'studyFirstSubmitQcDate': '2011-03-21', 'lastUpdatePostDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transverse dimensional changes and bucco-lingual inclination changes', 'timeFrame': '3 years 10 months', 'description': 'Width in mm'}], 'secondaryOutcomes': [{'measure': 'Subjective pain experience', 'timeFrame': '3 years 10 months', 'description': 'Pain score'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Self-ligating', 'orthodontic', 'appliance', 'expansion', 'dental inclination', 'Expansion and inclination changes'], 'conditions': ['Orthodontic Treatment']}, 'referencesModule': {'references': [{'pmid': '23910199', 'type': 'DERIVED', 'citation': 'Fleming PS, Lee RT, Marinho V, Johal A. Comparison of maxillary arch dimensional changes with passive and active self-ligation and conventional brackets in the permanent dentition: a multicenter, randomized controlled trial. Am J Orthod Dentofacial Orthop. 2013 Aug;144(2):185-93. doi: 10.1016/j.ajodo.2013.03.012.'}]}, 'descriptionModule': {'briefSummary': "This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.\n\nThe effects of three different types of train-track will be assessed with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop.", 'detailedDescription': "This is a clinical study involving patients undergoing orthodontic treatment with fixed appliances ('train-track braces'). A new type of train-track has recently been marketed. Over 4 million patients worldwide are wearing on of these appliances; this system is considerably more expensive than a normal train-track. However, there is little evidence to support its use.\n\nThe effects of three different types of train-track will be assessed in this clinical trial with respect to the quality of Orthodontic tooth movement produced. Furthermore, the impact of the different train-tracks on daily life of orthodontic patients will also be measured. Consequently, the investigators will be able to inform orthodontists' decisions relating to the choice of train-track they recommend for their patients. In addition, should the more expensive appliances demonstrate objective or subjective advantage, a significant efficiency saving may develop."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Young adults aged 16 years and over;\n* Fit and well and on no medication;\n* In the permanent dentition;\n* Undergoing orthodontic treatment in preparation for combined orthodontic-surgical care\n\nor\n\n* Subjects considered suitable for non-extraction maxillary arch treatment if not undergoing combined orthodontic-surgical treatment;\n* Crowding less than 6mm\n\nExclusion Criteria\n\n* Cleft lip and palate and other craniofacial anomalies.'}, 'identificationModule': {'nctId': 'NCT01320657', 'briefTitle': 'A Clinical Trial of Three Fixed Orthodontic Appliances', 'organization': {'class': 'OTHER', 'fullName': 'Barts & The London NHS Trust'}, 'officialTitle': 'A Randomised Clinical Trial of Orthodontic Treatment With 3 Fixed Appliance Systems Assessed Using Digital Models', 'orgStudyIdInfo': {'id': '2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'InOvation C', 'description': 'Active Self-ligating Bracket', 'interventionNames': ['Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ovation', 'description': 'Conventional Bracket', 'interventionNames': ['Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket']}, {'type': 'EXPERIMENTAL', 'label': 'Damon Q', 'description': 'Self-ligating bracket', 'interventionNames': ['Device: Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket']}], 'interventions': [{'name': 'Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket', 'type': 'DEVICE', 'description': "Subjects randomized to treatment with one of three fixed orthodontic appliances: Damon Q, InOvation C and Ovation brackets. A pre-determined archwire sequence will be used involving round nickel titanium, rectangular nickel titanium progressing to 0.019 X 0.025 inch stainless steel; specific archwire sequences and appointment intervals will be based on the manufacturer's guidelines. All erupted teeth will have attachments placed from the outset.\n\nTreated for a minimum of 8 months with the 0.019 X 0.025 inch stainless steel archwire in place for at least 8 weeks.", 'armGroupLabels': ['Damon Q', 'InOvation C', 'Ovation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CT1 3NG', 'city': 'Canterbury', 'state': 'Kent', 'country': 'United Kingdom', 'facility': 'East Kent Hospitals NHS Foundation Trust', 'geoPoint': {'lat': 51.27904, 'lon': 1.07992}}, {'zip': 'E1 1BB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Royal London Dental Institute', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Robert t Lee, MDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal London Dental Institute'}, {'name': 'Ama Johal, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QMUL'}, {'name': 'Valeria Marinho, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'QMUL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barts & The London NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'East Kent Hospitals University NHS Foundation Trust', 'class': 'OTHER_GOV'}, {'name': 'Southend NHS Foundation Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}