Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:53 PM
Study NCT ID:
NCT05345756
Status:
UNKNOWN
Last Update Posted:
2022-04-26
First Post:
2022-03-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-19', 'studyFirstSubmitDate': '2022-03-26', 'studyFirstSubmitQcDate': '2022-04-19', 'lastUpdatePostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maxillary skeletal changes', 'timeFrame': '8 months', 'description': 'using lateral cephalometric x-ray to measure maxillary skeletal changes using angular measurements in degrees (SNA)'}], 'secondaryOutcomes': [{'measure': 'Mandibular skeletal changes', 'timeFrame': '8 months', 'description': 'using lateral cephalometric x-ray to measure mandibular skeletal changes using angular measurements in degrees (SNB)'}, {'measure': 'Maxillary and Mandibular dental changes', 'timeFrame': '8 months', 'description': 'using lateral cephalometric x-ray to measure changes using angular measurements in degrees (U1/Palatal plane ,L1/Mandibular plane)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Orthodontic Appliance Complication']}, 'descriptionModule': {'briefSummary': 'The study compares use of intraoral technique for maxillary advancement and extra oral technique with hep of protocol called Alt-RAMEC which depends on repeated expansion and constriction of maxilla to help in maxillary protraction', 'detailedDescription': 'Delivering hybrid expander supported by 2 miniscrews in palate to perform Alt-RAMEC protocol for 9 weeks then intervention group will start protraction using class iii elastics on modified lingual arch with hooks in canine area and 2 miniscrews labially between lower lateral and canine while control group use face mask for protraction of maxilla'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '9 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or Female Growing Patient ( CVM2-CVM3 )\n* Skeletal class III (ANB ≤ 0 , A-NV≤ -2 and wits appraisal \\< -0.3mm)\n* Erupted upper and lower first permanent molars and permanent incisors\n* Reverse overjet up to -4 mm\n\nExclusion Criteria:\n\n* History of previous orthodontic treatment\n* Cleft lip/palate patients\n* Patients with habits that are detrimental to dental occlusion (thumb sucking, tongue thrusting).\n* Patients with syndromes'}, 'identificationModule': {'nctId': 'NCT05345756', 'acronym': 'ALT-RAMEC', 'briefTitle': 'Intraoral Maxillary Protraction Technique vs Facemask Using Alt-RAMEC Protocol for Treatment Class III Growing Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Intraoral Maxillary Protraction Technique With ALT-RAMEC ( Alternate Rapid Maxillary Expansion and Constriction) Protocol Versus Facemask With Maxillary Expansion in Treating Class III Growing Patients With Maxillary Deficiency: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'ASR1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intraoral Protraction Technique', 'description': 'using intraoral appliance composed of modified lingual arch and miniscrews for indirect anchorage for maxillary protraction after Alt-RAMEC protocol using hybrid expander', 'interventionNames': ['Device: Intraoral protraction device']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Extraoral Protraction Technique', 'description': 'using facemask for maxillary protraction after ALT-RAMEC protocol', 'interventionNames': ['Device: Extraoral protraction device']}], 'interventions': [{'name': 'Intraoral protraction device', 'type': 'DEVICE', 'description': 'Use of modified lingual arch with indirect anchorage from screws between lower lateral incisor and lower canine to protract maxilla after ALT-RAMEC protocol', 'armGroupLabels': ['Intraoral Protraction Technique']}, {'name': 'Extraoral protraction device', 'type': 'DEVICE', 'description': 'Facemask which is an extraoral appliance used for maxillary protraction', 'armGroupLabels': ['Extraoral Protraction Technique']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11553', 'city': 'Cairo', 'state': 'Manial', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': "Andrew Wafdy, Bachelor's", 'role': 'CONTACT', 'email': 'androwafdy@gmail.com', 'phone': '+0201272912299'}], 'facility': 'Faculty of Oral and dental medicine - Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Andrew Demian, BDS', 'role': 'CONTACT', 'email': 'androwafdy@gmail.com', 'phone': '+0201272912299'}], 'overallOfficials': [{'name': 'Andrew Demian, BDS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Andrew Wafdy Nan Demian', 'investigatorAffiliation': 'Cairo University'}}}}