Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT05489302
Status:
UNKNOWN
Last Update Posted:
2023-08-18
First Post:
2022-08-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-16', 'studyFirstSubmitDate': '2022-08-04', 'studyFirstSubmitQcDate': '2022-08-04', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'amount of maxillary protraction', 'timeFrame': '6 months', 'description': 'protraction of maxilla using CBCT'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Expansion', 'maxillary protraction', 'class III'], 'conditions': ['Maxillary Protraction in Class III Adolescent After Using (MSE)']}, 'referencesModule': {'references': [{'pmid': '15748102', 'type': 'BACKGROUND', 'citation': 'Liou EJ, Tsai WC. A new protocol for maxillary protraction in cleft patients: repetitive weekly protocol of alternate rapid maxillary expansions and constrictions. Cleft Palate Craniofac J. 2005 Mar;42(2):121-7. doi: 10.1597/03-107.1.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study of this study is to compare two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion using cone beam computed tomography (CBCT)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Class3 Patients suffering maxillary collapse with a skeletal background\n* Patients with retrognathic maxilla.\n* Patients with anterior cross-bite or incisor end-to-end relationship\n* Patients with unilateral or bilateral posterior crossbite.\n* Patients with no periodontal disease.\n* Patients with good oral hygiene and general health.\n* No systemic diseases that may affect bone quality or interfere with orthodontic treatment.\n* Patients with no previous orthodontic treatment.\n\nExclusion Criteria:\n\n* previous orthodontic treatment.\n* Craniofacial syndrome.'}, 'identificationModule': {'nctId': 'NCT05489302', 'briefTitle': 'Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE)', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE) Alt-RAMEC vs Conventional Rapid Palatal Expansion Randomized Controlled Trial -CBCT Study', 'orgStudyIdInfo': {'id': '828/220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '(MSE) Alt-RAMEC protocol', 'interventionNames': ['Device: Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol.']}, {'type': 'ACTIVE_COMPARATOR', 'label': '(MSE) conventional protocol', 'interventionNames': ['Device: Maxillary skeletal expander with protraction face mask with conventional protocol']}], 'interventions': [{'name': 'Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol.', 'type': 'DEVICE', 'description': 'The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by Alt-RAMEC protocol.', 'armGroupLabels': ['(MSE) Alt-RAMEC protocol']}, {'name': 'Maxillary skeletal expander with protraction face mask with conventional protocol', 'type': 'DEVICE', 'description': 'The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by conventional protocol', 'armGroupLabels': ['(MSE) conventional protocol']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'state': 'Nasr City', 'country': 'Egypt', 'facility': 'Mohamed Shendy', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Evaluation of two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Mohamed Abdelrhman Shendy Abdelrhman', 'investigatorAffiliation': 'Al-Azhar University'}}}}