Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2025-12-26 @ 3:38 AM
Study NCT ID:
NCT05232318
Status:
UNKNOWN
Last Update Posted:
2023-01-10
First Post:
2021-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012391', 'term': 'Root Resorption'}], 'ancestors': [{'id': 'D014091', 'term': 'Tooth Resorption'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-09', 'studyFirstSubmitDate': '2021-12-18', 'studyFirstSubmitQcDate': '2022-01-29', 'lastUpdatePostDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amount of Root resorption', 'timeFrame': '8 months', 'description': 'Using pretreatment and posttreatment CBCT, volumetric root resorption will be measured by using 3D imaging software'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Root Resorption']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare apical root resorption accompanied orthodontic treatment using clear aligners vs fixed appliances.', 'detailedDescription': 'by using pretreatment and posttreatment CBCT, root resorption will be measured using a 3D imaging software.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy systemic condition/no systemic illness, as reported by patients.\n* No use any form of anti - inflammatory drugs the at beginning of study.\n* Good oral hygiene.\n* Cooperative and motivated.\n* In the permanent dentition with all teeth present ( except third molars).\n* Minimum to moderate anterior crowding.\n* No previous orthodontic treatment.\n\nExclusion Criteria:\n\n* Previous upper removable orthodontic treatment.\n* Patients who required surgery to correct skeletal discrepancies.\n* Patients with hyperdontia, hypodontia, or syndromic diseases (e.g. cleft lip and palate).\n* Uncooperative patients.\n* Patients with poor oral hygiene.'}, 'identificationModule': {'nctId': 'NCT05232318', 'briefTitle': 'Root Resorption Accompanied Clear Aligners and Fixed Orthodontic Appliance', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Apical Root Resorption Accompanied Orthodontic Treatment Using Clear Aligners Versus Fixed Appliances: A CBCT Comparative Study', 'orgStudyIdInfo': {'id': '357/1150'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'leveling and alignment using fixed orthodontic appliance', 'description': 'leveling and alignment using fixed orthodontic appliance', 'interventionNames': ['Other: Leveling and alignment']}, {'type': 'EXPERIMENTAL', 'label': 'leveling and alignment using clear aligner', 'description': 'leveling and alignment using clear aligner', 'interventionNames': ['Other: Leveling and alignment']}, {'type': 'EXPERIMENTAL', 'label': 'leveling and alignment using clear aligner with low level laser therapy', 'description': 'leveling and alignment using clear aligner with low level laser therapy', 'interventionNames': ['Other: Leveling and alignment']}], 'interventions': [{'name': 'Leveling and alignment', 'type': 'OTHER', 'description': 'Root resorption comparison through the use of CBCT', 'armGroupLabels': ['leveling and alignment using clear aligner', 'leveling and alignment using clear aligner with low level laser therapy', 'leveling and alignment using fixed orthodontic appliance']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Or', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'AlAzhar A University', 'role': 'CONTACT', 'email': 'Dent.b.dean@azhar.edu.eg', 'phone': '+201001405584'}], 'facility': 'AlAzhar Azhar University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'city': 'Cairo', 'status': 'NOT_YET_RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'AlAzhar University', 'role': 'CONTACT', 'email': 'Dent.b.dean@azhar.edu.eg', 'phone': '+201001405584'}], 'facility': 'Al Azhar university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Obaida K Eldlemy', 'role': 'CONTACT', 'email': 'ObaidaKhalil.209@azhar.edu.eg', 'phone': '+201111488819'}, {'name': 'Obaida K Eldlemy', 'role': 'CONTACT', 'email': 'obaida.khalil91@gmail.com', 'phone': '+201111488819'}], 'overallOfficials': [{'name': 'Ahmed M Abouelnour, Lecturer', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer, Department of Orthodontics'}, {'name': 'Ramadan Y Aboushahba, Associate professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Associate professor, Department of Orthodontics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Obaida Khaleel Ibrahim', 'investigatorAffiliation': 'Al-Azhar University'}}}}