Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-05 @ 11:53 AM
Study NCT ID:
NCT03365232
Status:
UNKNOWN
Last Update Posted:
2017-12-07
First Post:
2017-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-02', 'studyFirstSubmitDate': '2017-11-25', 'studyFirstSubmitQcDate': '2017-12-02', 'lastUpdatePostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'accuracy of orthodontic attachments transfer', 'timeFrame': 'one day after bonding', 'description': 'linear (mm) scale using geomagic software'}, {'measure': 'accuracy of orthodontic attachments transfer', 'timeFrame': 'one day after bonding', 'description': 'angular (degrees) scale using geomagic software'}], 'primaryOutcomes': [{'measure': 'chair side time', 'timeFrame': 'an average of 30 minutes', 'description': 'using stopwatch'}], 'secondaryOutcomes': [{'measure': 'immediate bond failure', 'timeFrame': 'immediately after bonding', 'description': 'number of debonded attachments using hand instrument pressure'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Appliance Complication']}, 'descriptionModule': {'briefSummary': 'compare the chair side time, clinical orthodontic attachment bond failure and accuracy of transfer between non custom attachment base and custom attachment base indirect techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients should have\n\n1. Maxillary sound teeth and undergoing fixed orthodontic treatment.\n2. Space problems ranging from spacing to mild crowding.\n3. Good oral hygiene.\n\nExclusion Criteria:\n\n1. Patients with partially erupted teeth in the maxillary arch .\n2. Signs of caries, large restorations fluorosis, hypoplasia or abnormalities of crown morphology.\n3. The need of banding.\n4. Bad oral hygiene measures.'}, 'identificationModule': {'nctId': 'NCT03365232', 'briefTitle': 'Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Chairside Time and Bond Failure of Non Custom Versus Custom Base Orthodontic Attachments During Indirect Bonding: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'CEBC-CU-2017-11-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'non custom base attachment', 'interventionNames': ['Device: non custom base attachment']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'custom base attachment', 'interventionNames': ['Device: custom base attachment']}], 'interventions': [{'name': 'non custom base attachment', 'type': 'DEVICE', 'description': 'non custom base attachment', 'armGroupLabels': ['non custom base attachment']}, {'name': 'custom base attachment', 'type': 'DEVICE', 'description': 'custom base attachment', 'armGroupLabels': ['custom base attachment']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mohamed Saied Mahmoud Hassan', 'investigatorAffiliation': 'Cairo University'}}}}