Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-03-04 @ 9:48 PM
Study NCT ID:
NCT07038902
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Comparative Study Between Modified Miniscrew-Assisted Rapid Palatal Expander And Modified Rapid Palatal Expander in Molar Distalization Using Cone- Beam Computed Tomography
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-23', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of Molar Distalization Measured by CBCT', 'timeFrame': 'Baseline (prior to initiation of molar distalization) At the end of the molar distalization phase (approximately 12 weeks post-treatment initiation).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Modified MARPE', 'Modified RPE', 'Molar Distalization', 'CBCT', 'Orthodontics'], 'conditions': ['Malocclusion, Class I/II', 'Crowding', 'Maxillary First Molar Distalization']}, 'descriptionModule': {'briefSummary': 'Comparative study between modified miniscrew-assisted rapid palatal expander and modified rapid palatal expander in molar distalization using CBCT.', 'detailedDescription': 'This research will be conducted as a prospective and randomized clinical trial.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence of permanent dentition\n* Skeletal Class I\n* Dental Class II molar relationship with moderate dental crowding\n* Crowding \\>4mm\n* Good oral hygiene\n* Healthy periodontal condition\n\nExclusion Criteria:\n\n* Presence of craniofacial syndromes or cleft palate\n* History of previous orthodontic treatment\n* Poor oral hygiene or active periodontal disease\n* Contraindications to CBCT imaging (e.g., pregnancy, inability to remain still during the scan)'}, 'identificationModule': {'nctId': 'NCT07038902', 'acronym': 'MIDPAC', 'briefTitle': 'A Comparative Study Between Modified Miniscrew-Assisted Rapid Palatal Expander And Modified Rapid Palatal Expander in Molar Distalization Using Cone- Beam Computed Tomography', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'A Comparative Study Between Modified Miniscrew-Assisted Rapid Palatal Expander And Modified Rapid Palatal Expander in Molar Distalization Using Cone- Beam Computed Tomography', 'orgStudyIdInfo': {'id': 'MMARPE-MRPE-CBCT-DISTAL2025-AZ'}, 'secondaryIdInfos': [{'id': 'MIDPAC-AZU-2025', 'type': 'REGISTRY', 'domain': 'Clinical Trials.gov'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)', 'interventionNames': ['Device: Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)']}, {'type': 'EXPERIMENTAL', 'label': 'Modified Rapid Palatal Expander (RPE)', 'interventionNames': ['Device: Group B: Modified Rapid Palatal Expander (RPE)']}], 'interventions': [{'name': 'Group A: Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)', 'type': 'DEVICE', 'description': 'A skeletal anchorage-supported with miniscrews inserted into the palate using a self-drilling technique.', 'armGroupLabels': ['Modified Miniscrew-Assisted Rapid Palatal Expander (MARPE)']}, {'name': 'Group B: Modified Rapid Palatal Expander (RPE)', 'type': 'DEVICE', 'description': 'A tooth-borne anchorage focusing on molar distalization .', 'armGroupLabels': ['Modified Rapid Palatal Expander (RPE)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'facility': 'Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Mohammed Ahmed Salim, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Orthodontics, Faculty of Dental Medicine, Al-Azhar University, Assiut branch.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Researcher, Al-Azhar University (Assiut branch)', 'investigatorFullName': 'Marwa Abd ELhamid Ahmed Abu Elhagag', 'investigatorAffiliation': 'Al-Azhar University'}}}}