Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2026-01-16 @ 11:54 PM
Study NCT ID:
NCT07141602
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-26
First Post:
2025-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Correlation Between Stages of Mandibular 2nd Molar Calcification and CVMI for Assessment of Skeletal Maturation: A Cross Sectional Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 212}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-08-19', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'to evaluate the frequency of stage E of dental index in female subjects.', 'timeFrame': 'one year', 'description': 'to evaluate the frequency of stage E of dental index in female subjects.'}], 'secondaryOutcomes': [{'measure': 'to evaluate relationships between the stages of calcification of mandibular second molar (DI) and cervical vertebrae maturation index (CVMI).', 'timeFrame': 'one year', 'description': 'to evaluate relationships between the stages of calcification of mandibular second molar (DI) and cervical vertebrae maturation index (CVMI).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['second molar tooth, cervical vertebrae maturation, skeletal maturation, lateral cephalogram, panorama'], 'conditions': ['Correlation Between Second Molar Calcification Stage and CVMI for Skeletal Maturation Assessment in Egyptian Population']}, 'descriptionModule': {'briefSummary': 'The aims of this study will be:\n\n1. To investigate the relationships between mandibular second molar calcification stages and skeletal maturity in Egyptian population, and\n2. To evaluate whether the mandibular second molar calcification stages can be used as a reliable diagnostic tool to assess skeletal maturity in Egyptian population.', 'detailedDescription': 'This cross-sectional study will include 106 Egyptian subjects with age range between 9 and 18 years old, who will present to outpatient clinic of Orthodontic department, Faculty of Dentistry, Cairo University, and will be classified according to their gender into two groups (males and females). Radiographs (panorama and cephalogram) will be collected from all study participants who meet inclusion criteria for data analysis. The inclusion criteria will be as follows:\n\n* Chronological age ranging from 9 to 18 years\n* No serious illness\n* Normal overall growth and development\n* Absence of abnormal dental conditions, such as impaction, transposition, and congenitally missing teeth\n* Absence of previous history of trauma or disease to the face and neck\n* Absence of orthodontic treatment\n* No permanent teeth extracted\n\nWe will obtain panoramic and lateral cephalometric radiographs of 106 Egyptian subjects from the pretreatment records of patients attending clinics for orthodontic treatment.\n\nAll radiographic assessments will be performed in a darkened room. Any radiograph that shows motion dullness or has poor contrast will be discarded. A single radiologist will expose and develop all radiographs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '9 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '212 Egyptian subjects with their age ranging between 9 and 18 years old, who will present to outpatient clinic of Orthodontic department, Faculty of Dentistry, Cairo University.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Chronological age ranging from 9 to 18 years\n\n * No serious illness\n * Normal overall growth and development\n * Absence of abnormal dental conditions, such as impaction, transposition, and congenitally missing teeth\n * Absence of previous history of trauma or disease to the face and neck\n * Absence of orthodontic treatment\n * No permanent teeth extracted\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT07141602', 'briefTitle': 'Correlation Between Stages of Mandibular 2nd Molar Calcification and CVMI for Assessment of Skeletal Maturation: A Cross Sectional Study', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Correlation Between Stages of Mandibular Second Molar Calcification and Cervical Vertebrae Maturation Index for Assessment of Skeletal Maturation: A Cross Sectional Study', 'orgStudyIdInfo': {'id': 'ORTH7-3-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'will include males', 'interventionNames': ['Diagnostic Test: lateral cephalometric x- ray and dental panoramic tomogram']}, {'label': 'will include females', 'interventionNames': ['Diagnostic Test: lateral cephalometric x- ray and dental panoramic tomogram']}], 'interventions': [{'name': 'lateral cephalometric x- ray and dental panoramic tomogram', 'type': 'DIAGNOSTIC_TEST', 'description': 'lateral cephalometric x- ray and dental panoramic tomogram', 'armGroupLabels': ['will include females', 'will include males']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gizah-Egypt', 'country': 'Egypt', 'facility': 'Faculty of Dentistry-Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Abd El-Ghafour', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Mohamed Abd El-Ghafour Omar, BDS, MSc, PhD', 'investigatorFullName': 'Mohamed Abd El-Ghafour', 'investigatorAffiliation': 'Cairo University'}}}}