Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05654558
Status:
COMPLETED
Last Update Posted:
2022-12-16
First Post:
2022-12-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057887', 'term': 'Overbite'}], 'ancestors': [{'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}, {'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-08', 'studyFirstSubmitDate': '2022-12-08', 'studyFirstSubmitQcDate': '2022-12-08', 'lastUpdatePostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overbite', 'timeFrame': 'six months', 'description': 'Distance between incisal edges of upper and lower incisors measured on lateral cephalometric x-rays'}, {'measure': 'True incisor intrusion', 'timeFrame': 'six months', 'description': 'Perpendicular distance between the center of resistance of mandibular central incisor and the mandibular plane measured on lateral cephalometric x-rays'}, {'measure': 'Proclination of lower incisors', 'timeFrame': 'six months', 'description': 'Angle formed by the long axis of mandibular central incisor and mandibular plane measured on lateral cephalometric x-rays'}, {'measure': 'Lower incisor intrusion and proclination', 'timeFrame': 'six months', 'description': 'Perpendicular distance between the incisal edge of the lower central incisor and mandibular plane measured on lateral cephalometric x-rays'}, {'measure': 'Lower incisor intrusion', 'timeFrame': 'six months', 'description': 'Perpendicular distance between the apex of the lower central incisor and mandibular plane measured on lateral cephalometric x-rays'}, {'measure': 'Extrusion of lower first molar', 'timeFrame': 'six months', 'description': 'Perpendicular distance between the mesio-buccal cusp tip of the lower first molar and mandibular plane measured on lateral cephalometric x-rays'}, {'measure': 'Distal tip of lower first molar', 'timeFrame': 'six months', 'description': 'Angle formed between the long axis of lower 1st molar and mandibular plane measured on lateral cephalometric x-rays'}], 'secondaryOutcomes': [{'measure': 'Depth of curve of Spee', 'timeFrame': 'six months', 'description': 'Measured on dental casts by summing the right and left side maximum depths from a flat plane formed by the tips of the mandibular incisors anteriorly and the distal cusp tips of the second molars posteriorly'}, {'measure': 'Depth of gingival sulcus', 'timeFrame': 'six months', 'description': 'The sulcus depth was measured using Michigan O periodontal probe.'}, {'measure': 'Width of keratinized gingiva', 'timeFrame': 'six months', 'description': 'Measured with the aid of periodontal probe from the free gingival margin to the mucogingival junction.'}, {'measure': 'Root resorption of lower incisors', 'timeFrame': 'six months', 'description': 'Length of lower incisor roots was compared in before- and after-periapical radiographs taken with a paralleling technique.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Deep Overbite']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to determine the effect of auxiliary intrusion cantilevers used with resilient archwires during the leveling and alignment phase in intruding lower incisors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Permanent dentition present except for third molars\n* No history of previous orthodontic treatment.\n* Class I or II malocclusion with minimal or no lower anterior crowding (\\<3 mm)\n* Excessive overbite (\\>3 mm).\n\nExclusion Criteria:\n\n* Syndromic patients as well as individuals with skeletal asymmetry\n* Endodontically treated or periodontally involved loweranterior teeth.\n* Need for tooth extraction in the lower arch.\n* Agenesis (except for third molars)\n* Any kind of tooth/root shape anomaly'}, 'identificationModule': {'nctId': 'NCT05654558', 'briefTitle': 'Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Deep Bite Correction Using Auxiliary Intrusion Cantilevers With Initial Archwires in Adolescents', 'orgStudyIdInfo': {'id': '0049-08/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Auxiliary intrusion cantilevers', 'description': 'Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment.', 'interventionNames': ['Device: Auxiliary cantilever intrusion arches on initial archwires']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Routine leveling and alignment', 'description': "Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment.", 'interventionNames': ['Device: Routine leveling and alignment']}], 'interventions': [{'name': 'Auxiliary cantilever intrusion arches on initial archwires', 'type': 'DEVICE', 'description': 'Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription. Lower first molars received double tubed bands while 2nd molars received single bondable tubes. Leveling and alignment phase then started with 0.014 inch NiTi wires engaging all teeth and synched behind 2nd molars. Two 0.017" x 0.025" TMA (Ormco) sectional wires were attached to auxiliary tubes on 1st molars with tip back bends mesial to the molars and attached with hooks distal to lateral incisors on top of basal leveling arch wire. Amount of intrusive force was measured to range between 20 and 40 grams per side. Basal leveling arches were upgraded whenever needed. All patients were assessed after 6 months of treatment.', 'armGroupLabels': ['Auxiliary intrusion cantilevers']}, {'name': 'Routine leveling and alignment', 'type': 'DEVICE', 'otherNames': ['Relative Intrusion'], 'description': "Patients received a full set of 0.022- inch slot brackets (Mini 2000, Ormco) with Roth prescription, 1st and 2nd molars received tubes or bands according to each patient's further needs Lower arch was leveled and aligned with sequential wires starting with 14 NiTi and upgraded when needed. All patients were assessed after 6 months of treatment.", 'armGroupLabels': ['Routine leveling and alignment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21527', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Faculty of Dentistry, Alexandria University', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Mona Elmaghraby, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Hanan Ismail, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}, {'name': 'Hassan Kassem, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Faculty of Dentistry, Alexandria University, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MSc candidate, Orthodontics Department, Faculty of Dentistry, Alexandria University', 'investigatorFullName': 'Mona El-Maghraby', 'investigatorAffiliation': 'Alexandria University'}}}}