Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-29 @ 8:02 PM
Study NCT ID:
NCT04357067
Status:
COMPLETED
Last Update Posted:
2020-04-22
First Post:
2020-04-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}], 'ancestors': [{'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-21', 'studyFirstSubmitDate': '2020-04-19', 'studyFirstSubmitQcDate': '2020-04-21', 'lastUpdatePostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Irregularity index (mm)', 'timeFrame': '18 weeks', 'description': 'Crowding of anterior teeth changes after alignment'}, {'measure': 'Distance between canine teeth (mm)', 'timeFrame': '18 weeks', 'description': 'Measurement from right canine to left canine distance'}, {'measure': 'Distance between first premolar teeth (mm)', 'timeFrame': '18 weeks', 'description': 'Measurement from right first premolar to left first premolar distance'}, {'measure': 'Distance between second premolar teeth (mm)', 'timeFrame': '18 weeks', 'description': 'Measurement from right first premolar to left first premolar distance'}, {'measure': 'Distance between first molar teeth (mm)', 'timeFrame': '18 weeks', 'description': 'Measurement from right first molar to left first molar distance'}], 'secondaryOutcomes': [{'measure': 'Arch length (mm)', 'timeFrame': '18 weeks', 'description': 'Measurement of arch length from mesial side of right first molar to messiah side of left first molar'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Customized lingual brackets', 'lingual orthodontics', 'digital model'], 'conditions': ['Irregular Teeth']}, 'referencesModule': {'references': [{'pmid': '25707826', 'type': 'BACKGROUND', 'citation': 'Khattab TZ, Hajeer MY, Farah H, Al-Sabbagh R. Maxillary dental arch changes following the leveling and alignment stage with lingual and labial orthodontic appliances: a preliminary report of a randomized controlled trial. J Contemp Dent Pract. 2014 Sep 1;15(5):561-6. doi: 10.5005/jp-journals-10024-1579.'}, {'pmid': '24005948', 'type': 'BACKGROUND', 'citation': 'Auluck A. Lingual orthodontic treatment: what is the current evidence base? J Orthod. 2013 Sep;40 Suppl 1:S27-33. doi: 10.1179/1465313313Y.0000000073.'}, {'pmid': '29546390', 'type': 'BACKGROUND', 'citation': 'Alobeid A, El-Bialy T, Reimann S, Keilig L, Cornelius D, Jager A, Bourauel C. Comparison of the efficacy of tooth alignment among lingual and labial brackets: an in vitro study. Eur J Orthod. 2018 Nov 30;40(6):660-665. doi: 10.1093/ejo/cjy005.'}, {'pmid': '24785929', 'type': 'BACKGROUND', 'citation': 'Ziebura T, Hohoff A, Flieger S, Stamm T. Accidental debondings: Buccal vs fully individualized lingual multibracket appliances. Am J Orthod Dentofacial Orthop. 2014 May;145(5):649-54. doi: 10.1016/j.ajodo.2013.12.030.'}, {'pmid': '22573909', 'type': 'BACKGROUND', 'citation': 'Sifakakis I, Pandis N, Makou M, Eliades T, Katsaros C, Bourauel C. A comparative assessment of torque generated by lingual and conventional brackets. Eur J Orthod. 2013 Jun;35(3):375-80. doi: 10.1093/ejo/cjs029. Epub 2012 May 9.'}, {'pmid': '21464153', 'type': 'BACKGROUND', 'citation': 'Sifakakis I, Pandis N, Makou M, Katsaros C, Eliades T, Bourauel C. A comparative assessment of forces and moments generated by lingual and conventional brackets. Eur J Orthod. 2013 Feb;35(1):82-6. doi: 10.1093/ejo/cjr048. Epub 2011 Apr 4.'}, {'pmid': '16231112', 'type': 'BACKGROUND', 'citation': 'Fuck LM, Wiechmann D, Drescher D. Comparison of the initial orthodontic force systems produced by a new lingual bracket system and a straight-wire appliance. J Orofac Orthop. 2005 Sep;66(5):363-76. doi: 10.1007/s00056-005-0442-3. English, German.'}]}, 'descriptionModule': {'briefSummary': 'This aim study aims to compare clinical effectiveness of customized lingual brackets and conventional labial brackets in alignment period in a sample of Class I malocclusion patients treated on a nonextraction basis.', 'detailedDescription': "The study included 20 patients who presented with Class I malocclusion and scheduled for orthodontic treatment without tooth extraction. The patients were randomly assigned for treatment with customized lingual brackets or with conventional labial brackets. During the alignment period 0.012 inch (T1) , 0.014 inch(T2), 0.016 inch (T3)NiTi arch wires were performed respectively and the control visits were scheduled by 6-weeks intervals. In all sessions, digital models were obtained by intra-oral scanning device after removal of arch wire, which then analyzed by software. In order to analyze change in T0 (pretreatment), T1, T2 and T3; Little's irregularity index, distance between canine teeth, distance between first premolar teeth, distance between second premolar teeth, distance between first molar teeth and arch length measurements were performed on digital models."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '22 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class I malocclusion\n* Completed permanent dentition\n* Crowding ≥ 6 mm\n\nExclusion Criteria:\n\n* Tooth loss or extraction except third molars\n* Having cross bite\n* Having genetic or hormonal disorder\n* Using a chronic drug\n* Previous orthodontic treatment and prosthetic restoration\n* Inappropriate oral hygiene and periodontal diseases'}, 'identificationModule': {'nctId': 'NCT04357067', 'briefTitle': 'Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Comparison of the Clinical Efficacy of the Lingual Brackets and Labial Brackets in the Leveling Phase', 'orgStudyIdInfo': {'id': 'DHF-15010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lingual brackets', 'description': 'Patients with moderate crowding without extraction treated with Incognito lingual bracket (3M Unitek, Bad Essen, Germany)', 'interventionNames': ['Device: Lingual brackets', 'Device: Labial brackets']}, {'type': 'EXPERIMENTAL', 'label': 'Labial brackets', 'description': 'Patients with moderate crowding without extraction treated with labial bracket (3M Unitek, Ca, USA', 'interventionNames': ['Device: Lingual brackets', 'Device: Labial brackets']}], 'interventions': [{'name': 'Lingual brackets', 'type': 'DEVICE', 'otherNames': ['Customized lingual brackets'], 'description': 'A type of bracket that applied lingual surface of teeth.', 'armGroupLabels': ['Labial brackets', 'Lingual brackets']}, {'name': 'Labial brackets', 'type': 'DEVICE', 'otherNames': ['Conventional labial brackets'], 'description': 'A type of bracket that applied labial surface of teeth.', 'armGroupLabels': ['Labial brackets', 'Lingual brackets']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yazgı Ay Ünüvar, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Aydın Adnan Menderes University Faculty of Dentistry Department of Orthodontics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aydin Adnan Menderes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'YAZGI AY UNUVAR, PhD', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}