Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT05333094
Status:
UNKNOWN
Last Update Posted:
2022-04-18
First Post:
2022-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison Between the Effectiveness of Different Commercial Bracket Brands
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003441', 'term': 'Crowding'}], 'ancestors': [{'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016910', 'term': 'Orthodontic Brackets'}], 'ancestors': [{'id': 'D000077744', 'term': 'Orthodontic Appliances, Fixed'}, {'id': 'D009967', 'term': 'Orthodontic Appliances'}, {'id': 'D009970', 'term': 'Orthodontics'}, {'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Single (Outcomes Assessor) Only the outcome assessors will be blind. The patients name will be sealed from pre and post radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-11', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-11', 'lastUpdatePostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Pain of intervention', 'timeFrame': 'From pre to post levelling and alignment (an average of 6 - 8 months)', 'description': 'Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 1-10'}], 'primaryOutcomes': [{'measure': 'Tip', 'timeFrame': 'From pre to post levelling and alignment (an average of 6 - 8 months)', 'description': 'The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)'}, {'measure': 'torque', 'timeFrame': '3 months after reaching 19x25 stainless steel wire (an average of 6 - 8 months)', 'description': 'The principle investigator will examine pre and post CBCT radiographs in relation to lines and reference planes (measurements in degrees and mm)'}], 'secondaryOutcomes': [{'measure': 'Levelling and alignment', 'timeFrame': 'upto 6 months from the start of orthodontic treatment.', 'description': "The incisal edges of the anterior teeth and the buccal cusps of the posterior teeth are placed on the same horizontal level; and alignment is the lining up of teeth of an arch in order to achieve normal contact point relationships will be assessed by measuring Little's Irregularity Index (LII) using study models taken of the patients (measured in mm)"}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthodontic bracket brands', 'torque prescription', 'tip prescription', 'levelling and Alignment', 'Lateral Cephalometric Radiographs', 'CBCT', 'VAS'], 'conditions': ['Crowding, Tooth, Class I']}, 'descriptionModule': {'briefSummary': "There's a scarcity in literature concerning the comparison of the effectiveness of brackets in its torque and tip ability, the time takes for leveling and alignment comparing between different orthodontic bracket brands, and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with Class I molar relation and teeth crowding, in which different bracket brands will be compared.", 'detailedDescription': "Bracket effectiveness can be measured in a variety of ways, including torque, tip, time required for levelling and alignment, bracket failure, and the patient's visual analogue scale. All are viable options; therefore, we want to complete the orthodontic treatment and determine which brackets fulfilled the built-in bracket prescription and achieved success in terms of aesthetics, better smiles, better patient judgement, and function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '14 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient with full set of permanent teeth\n* Male and female (14-19 years old).\n* Positive patients' acceptance for the study\n* Patients have no history of previous orthodontic treatment.\n\nExclusion Criteria:\n\n* Patients with enamel or dentin defect or any teeth anomaly will be eliminated.\n* Patients having canine or lateral incisors peg shaped will be excluded from the research. - Medically compromised patients\n* Patients unable to give an informed consent\n* Patient with periodontal disease\n* Patient taking long term medication\n* Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth Breathing)"}, 'identificationModule': {'nctId': 'NCT05333094', 'briefTitle': 'Comparison Between the Effectiveness of Different Commercial Bracket Brands', 'organization': {'class': 'OTHER', 'fullName': 'Future University in Egypt'}, 'officialTitle': 'Comparison Between the Effectiveness of Different Commercial Bracket Brands, Having Roth Prescription and 0.022" Bracket Slot: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'FUE.REC(32)/12-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'American orthodontics brackets', 'description': 'Roth prescription, 0.022" slot size', 'interventionNames': ['Other: Brackets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'FANTA brackets', 'description': 'Roth prescription, 0.022" slot size', 'interventionNames': ['Other: Brackets']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MATT brackets', 'description': 'Roth prescription, 0.022" slot size', 'interventionNames': ['Other: Brackets']}], 'interventions': [{'name': 'Brackets', 'type': 'OTHER', 'description': 'Levelling and alignment for the bonded teeth through following the wire sequence: 0.014 NiTi, 16 NiTi, 0.016×0.022 NiTi and 0.017×0.025 StSt. (Wires from American Orthodontics)\n\n• After levelling and aligning is completed the patient will be referred for the uptake of post intervention records; a standardized dental photograph and CBCT after 6- 9 months)', 'armGroupLabels': ['American orthodontics brackets', 'FANTA brackets', 'MATT brackets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Leena Alaa', 'role': 'CONTACT', 'phone': '+201123880046'}], 'facility': 'Future University In Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Salma K. Yacoub', 'role': 'CONTACT', 'email': '20183314@fue.edu.eg', 'phone': '01119174379', 'phoneExt': '+20'}, {'name': 'Heba M. Dehis, Lecturer', 'role': 'CONTACT', 'email': 'heba.dehis@dentistry.cu.edu.eg', 'phone': '01020490611', 'phoneExt': '+20'}], 'overallOfficials': [{'name': 'Yehya A. Mostafa, Professor and Chairman', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Future University in Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'Data will be available after publication', 'ipdSharing': 'YES', 'description': 'All Collected IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Future University in Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Salma Khaled Kamal Yacoub', 'investigatorAffiliation': 'Future University in Egypt'}}}}