Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT00688233
Status:
UNKNOWN
Last Update Posted:
2008-06-02
First Post:
2008-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063173', 'term': 'Retrognathia'}, {'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-05', 'completionDateStruct': {'date': '2009-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-05-28', 'studyFirstSubmitDate': '2008-05-23', 'studyFirstSubmitQcDate': '2008-05-28', 'lastUpdatePostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overjet and Overbite', 'timeFrame': '2-6 month depending on the amount of OJ and OB and the patient compliances'}], 'secondaryOutcomes': [{'measure': 'sagittal and vertical cephalometric measurements', 'timeFrame': 'before-after'}]}, 'conditionsModule': {'keywords': ["Seifi's Functional, Class II/1, Mandibular Retrognathism"], 'conditions': ['Orthodontic Appliance Design', 'Retrognathism', 'Malocclusion, Angle Class II', 'Deepbite']}, 'descriptionModule': {'briefSummary': "For improving the appearance of protruded upper front teeth when lower front teeth may touch palatal mucosa or have proximity to that; the innovated Seifi's Functional Appliance may be used.", 'detailedDescription': "Records will be obtained for each patient by the same operator before treatment and at the end of treatment. The appliance in this study is designed by Prof. Seifi and will be constructed by a well trained technician in the orthodontic laboratory of shahid Beheshti School of dentistry under the supervision of the operator. The appliance consists of a jack screw in the midpalatal region plus two Adams' clasps on the upper 1st molars and four Kimia clasps on the buccal embrasure of the upper deciduous molars or premolars. For the mandibular portion there is an incisal clasp and incisors are capped by acrylic.\n\nThe participants will be advised to use the appliance 24 hours per day except for meal times and when brushing the teeth or reading Farsi or English in class room.\n\nEach patient will pay his/her first recall visit to the orthodontic department one week after the appliance delivery and will be instructed to turn the maxillary expansion jack screw 1:4 turn twice a week to achieve coordination of the upper and lower arches in the transverse dimension. The patients will be evaluated over one month intervals and necessary adjustments were made.\n\nAll cephalometric records, before and after treatment, will be coded and analyzed by a second party and the ultimate results and evaluations will be made."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 8 - 12 years old\n* Class Π division 1 malocclusion (ANB\\>4)\n* Increased over jet (\\>4mm)\n* Increased overbite (\\>4mm)\n\nExclusion Criteria:\n\n* History of previous orthodontic treatment\n* Evidence of craniofacial syndromes'}, 'identificationModule': {'nctId': 'NCT00688233', 'acronym': 'Seifi-Fx', 'briefTitle': "Effect of the Innovated Seifi's Functional Appliance on Skeletal and Dentoalveolar Changes of Class II/ 1, Deep Bite", 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'officialTitle': "Phase 1 Effect of the Innovated Seifi's Functional Appliance on the Skeletal and Dentoalveolar Changes of Class II/Division 1, Deep Bite Cases", 'orgStudyIdInfo': {'id': '234567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'F-seifi', 'interventionNames': ["Device: Seifi's Functional"]}], 'interventions': [{'name': "Seifi's Functional", 'type': 'DEVICE', 'otherNames': ['Functional Therapy', 'Class II correction', 'Deepbite correction'], 'description': "Patient with Class II Division 1 and Deepbite malocclusion will wear the Seifi's Functional to get the benefit of skeletal and dentoalveolar correction.", 'armGroupLabels': ['F-seifi']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tehran', 'state': 'Tehran Province', 'status': 'RECRUITING', 'country': 'Iran', 'contacts': [{'name': 'Nafiseh Memar Kermani, DDS', 'role': 'CONTACT', 'phone': '98-21-2240-3010'}, {'name': 'Massoud Seifi, DDS, MSD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Majid Bargrizan, DDS, MSD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nafiseh Memar Kermani, DDS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Dental School, Shahid Beheshti Medical Sciences University', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'centralContacts': [{'name': 'Massoud Seifi, DDS,MSD', 'role': 'CONTACT', 'email': 'seifimassoud@gmail.com', 'phone': '98-21-2204-3343'}], 'overallOfficials': [{'name': 'Massoud Seifi, DDS, MSD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shahid Beheshti Medical Sciences University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Professor Massoud Seifi', 'oldOrganization': 'Shahid Beheshti Medical University'}}}}