Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-02 @ 11:07 PM
Study NCT ID:
NCT05939102
Status:
COMPLETED
Last Update Posted:
2023-07-11
First Post:
2023-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}], 'ancestors': [{'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': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-08', 'studyFirstSubmitDate': '2023-06-30', 'studyFirstSubmitQcDate': '2023-07-08', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bracket bonding survival rate', 'timeFrame': '18 months', 'description': 'reports of bracket debonding using one of the two bonding techniques'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['resin-modified glass ionomer', 'surface preparation', 'orthodontic bracket'], 'conditions': ['Dental Malocclusion']}, 'referencesModule': {'references': [{'pmid': '36547526', 'type': 'BACKGROUND', 'citation': 'Ghoubril V, Changotade S, Lutomski D, Ghoubril J, Chakar C, Abboud M, Hardan L, Kharouf N, Khoury E. Cytotoxicity of V-Prep Versus Phosphoric Acid Etchant on Oral Gingival Fibroblasts. J Funct Biomater. 2022 Nov 28;13(4):266. doi: 10.3390/jfb13040266.'}, {'pmid': '31495756', 'type': 'BACKGROUND', 'citation': 'Ghoubril V, Ghoubril J, Khoury E. A comparison between RMGIC and composite with acid-etch preparation or hypochlorite on the adhesion of a premolar metal bracket by testing SBS and ARI: In vitro study. Int Orthod. 2020 Mar;18(1):127-136. doi: 10.1016/j.ortho.2019.07.003. Epub 2019 Sep 5.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study was to evaluate over eighteen months the clinical bonding failure and survival rates of the conventional bonding technique using the Transbond XT (3M Unitek, Monrovia, California, USA) and the RMGIC Fuji Ortho LC (GC Corporation, Tokyo, Japan) prepared with the V-prep. Therefore, one operator using the straight-wire technique bonded two hundred metallic brackets to upper and lower premolars of twenty-five patients requiring an orthodontic treatment. The randomized trial was a single-blind design in a split-mouth comparison. Each patient was randomly allocated one of the two bonding systems for each premolar on each side of the mouth. The bonding and rebonding techniques were standardized throughout the trial and bond failure was recorded each month for a period of eighteen months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* require full orthodontic treatment of both arches\n* mild or average overbite and crowding\n* no restorations on the buccal surface of the premolars\n\nExclusion Criteria:\n\n* Patients with required extractions in the treatment plan or with poor oral hygiene'}, 'identificationModule': {'nctId': 'NCT05939102', 'briefTitle': 'Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep', 'organization': {'class': 'OTHER', 'fullName': 'Saint-Joseph University'}, 'officialTitle': 'Eighteen-month Orthodontic Bracket Survival Rate With the Conventional Bonding Technique Versus RMGIC and V-prep: A Split-mouth RCT', 'orgStudyIdInfo': {'id': 'USJ-2020-010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional bracket bonding technique', 'interventionNames': ['Combination Product: Conventional bracket bonding technique']}, {'type': 'EXPERIMENTAL', 'label': 'V-prep combined with RMGIC for bracket bonding', 'interventionNames': ['Combination Product: v-prep combined with RMGIC for bracket bonding']}], 'interventions': [{'name': 'v-prep combined with RMGIC for bracket bonding', 'type': 'COMBINATION_PRODUCT', 'description': 'prepare the tooth surface with the V-prep, then bond a bracket with the RMGIC', 'armGroupLabels': ['V-prep combined with RMGIC for bracket bonding']}, {'name': 'Conventional bracket bonding technique', 'type': 'COMBINATION_PRODUCT', 'description': 'prepare the tooth with acid-etch, then bond a bracket using resin composite', 'armGroupLabels': ['Conventional bracket bonding technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17-5208', 'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Saint Joseph University', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}], 'overallOfficials': [{'name': 'Victor Ghoubril, Ms', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Saint-Joseph University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint-Joseph University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}