Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-03-03 @ 12:29 AM
Study NCT ID:
NCT00485602
Status:
UNKNOWN
Last Update Posted:
2007-06-13
First Post:
2007-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D003441', 'term': 'Crowding'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009970', 'term': 'Orthodontics'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-06', 'lastUpdateSubmitDate': '2007-06-12', 'studyFirstSubmitDate': '2007-06-12', 'studyFirstSubmitQcDate': '2007-06-12', 'lastUpdatePostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'study models', 'timeFrame': 'every 2 appointments (8 weeks)'}], 'secondaryOutcomes': [{'measure': 'occlusal photographs', 'timeFrame': 'every 3 appointments (12 weeks)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['malocclusion', 'aligner', 'crowding', 'expansion', 'orthodontic treatment'], 'conditions': ['Malocclusion']}, 'descriptionModule': {'briefSummary': 'The trial is aimed to investigate an orthodontic treatment with a new removable-part-time-wearing appliance, based on "High-Tech" technology.\n\nThe appliance should be wear only 12-14 hours a day, and is made of a single silicone aligner, made specifically for the patient, using 3-D screening technology of the patient\'s malocclusion. The aligner has a designed pathway "built-in" for the tooth to move, from the original position of the malocclusion to the "end point" - the correct position.\n\nThe force system, that is needed in order to generate tooth movement, is produced by tiny air-balloons which are incorporated in the aligner.\n\nThe study hypothesis is, that an orthodontic treatment can be done successfully with this part-time wearing appliance.', 'detailedDescription': "The appliance include:\n\n* silicone aligner (made specifically for the patient.\n* simple air pump to blow air in the tiny balloons.\n\nThe patient is guided to wear the appliance 12-14 hours a day, after filling air in the balloons, under the doctor's instructions.\n\nClinical examination for follow-up will be done every 4 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '68 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate class I malocclusion\n* good general health\n* good oral hygiene\n\nExclusion Criteria:\n\n* bad cooperation\n* any mental or health problem\n* severe class I malocclusion, class II or class III malocclusion'}, 'identificationModule': {'nctId': 'NCT00485602', 'briefTitle': 'Orthodontic Treatment With a Part-Time Wearing Esthetic Removable Appliance', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'orgStudyIdInfo': {'id': 'RAFENALIGN-HMO-CTIL'}}, 'armsInterventionsModule': {'interventions': [{'name': 'orthodontic treatment with "Rafenalign" appliance', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '91120', 'city': 'Jerusalem', 'country': 'Israel', 'contacts': [{'name': 'Arik Tzukert, DMD', 'role': 'CONTACT', 'email': 'arik@hadassah.org.il', 'phone': '0097226776095'}, {'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '0097226777572'}, {'name': 'Meir Redlich, PhD DMD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Meir Redlich, PhD DMD', 'role': 'CONTACT', 'email': 'mredlich@zahav.net.il', 'phone': '0097226776184'}], 'overallOfficials': [{'name': 'Meir Redlich', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}}}}