Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2026-03-06 @ 6:14 PM
Study NCT ID:
NCT04378205
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2020-05-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium
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'], 'maskingDescription': 'Psarticipants did not know which size is allocated/side.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A split mouth study design was applied. Each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch. Patients were assigned into one of 2 groups based on archwire sizes used. Group 1:- 0.014-inch and 0.018-inch NiTi Group 2:- 0.016-inch and 0.018-inch NiTi.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-05', 'studyFirstSubmitDate': '2020-05-02', 'studyFirstSubmitQcDate': '2020-05-05', 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pulpal blood flow changes', 'timeFrame': 'up to 4 weeks', 'description': 'Measurements were taken by the use of Laser Doppler Flowmeter mm/s'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulpal blood flow', 'Pfixed appliance', 'Alignment arch wire'], 'conditions': ['Orthodontic Appliance']}, 'descriptionModule': {'briefSummary': 'to record pulpal blood flow (PBF) changes associated with using 0.018-inch Nickel Titanium (NiTi) as the first alignment archwire during fixed orthodontic treatment.', 'detailedDescription': 'Forty healthy patients with lower arch mild crowding with less than 2mm contact point displacement at any teeth were included. A split mouth study design was applied. Where each patient received 2 archwire sizes at one time joined in the midline by crimpable hook and applied in the lower arch.\n\nPatients were assigned into one of 2 groups based on archwire sizes used. Group (1); 0.014-inch and 0.018-inch NiTi and Group (2); 0.016-inch and 0.018-inch NiTi. A Laser Doppler Flowmeter was used to measure PBF at different time intervals (T0-T5).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '25 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 18-25 years\n* Class I skeletal malocclusion\n* Mild lower arches crowding.\n* Contact point displacement less than 2 mm.\n* No previous orthodontic treatment\n\nExclusion Criteria:\n\n* Missing teeth\n* Poor oral hygiene\n* deep carious teeth\n* history of previous trauma\n* any medical conditions affecting blood vessels\n* smokers'}, 'identificationModule': {'nctId': 'NCT04378205', 'briefTitle': 'Pulpal Blood Flow Changes Using SuperElastic 0.018-inch Nickel Titanium', 'organization': {'class': 'OTHER', 'fullName': 'Jordan University of Science and Technology'}, 'officialTitle': 'Pulpal Blood Flow Changes Related to Using SuperElastic 0.018-inch Nickel Titanium as the First Orthodontic Alignment Archwire: A Prospective Clinical Trial', 'orgStudyIdInfo': {'id': '39/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.014/0.018 NiTi arch wire', 'description': '0.014-inch NiTi on one side /0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients', 'interventionNames': ['Procedure: 0.014-inch NiTi on one side /0.018-inch NiTi on the other side']}, {'type': 'EXPERIMENTAL', 'label': '0.016/0.018 NiTi arch wire', 'description': '0.016-inch NiTi on one side / 0.018-inch NiTi on the other side (Nitinol SuperElastic 3M, Unitek) for initial alignment. This group included 20 patients', 'interventionNames': ['Procedure: 0.016-inch NiTi on one side /0.018-inch NiTi on the other side']}], 'interventions': [{'name': '0.014-inch NiTi on one side /0.018-inch NiTi on the other side', 'type': 'PROCEDURE', 'description': 'Where each patient received 2 archwire sizes (0.014-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.', 'armGroupLabels': ['0.014/0.018 NiTi arch wire']}, {'name': '0.016-inch NiTi on one side /0.018-inch NiTi on the other side', 'type': 'PROCEDURE', 'description': 'Where each patient received 2 archwire sizes (0.016-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.', 'armGroupLabels': ['0.016/0.018 NiTi arch wire']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Irbid', 'country': 'Jordan', 'facility': 'Dental Faculty/Jordan university of Science and Technology Dental Teaching Clinics', 'geoPoint': {'lat': 32.55556, 'lon': 35.85}}], 'overallOfficials': [{'name': 'Elham Abu Alhaija, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jordan University of Science and Technology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Elham Abu Alhaija', 'investigatorAffiliation': 'Jordan University of Science and Technology'}}}}