Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT07170956
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-12
First Post:
2025-09-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Tooth Root Number
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014071', 'term': 'Tooth Abnormalities'}, {'id': 'D014076', 'term': 'Tooth Diseases'}], 'ancestors': [{'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-04', 'studyFirstSubmitDate': '2025-09-04', 'studyFirstSubmitQcDate': '2025-09-04', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tooth root number', 'timeFrame': 'The assessment is conducted once at the time of enrolment', 'description': 'Number of separate roots of a single tooth, regardless of the level of division'}], 'secondaryOutcomes': [{'measure': 'Male/female ratio', 'timeFrame': 'The assessment is conducted once at the time of data analysis', 'description': 'Proportion of different numbers of roots in male and female'}, {'measure': 'Age odds ratio', 'timeFrame': 'The assessment is conducted once at the time of analysis', 'description': 'Odds ratio of different numbers of roots with a distinction based on age'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tooth root', 'Tooth abnormalities', 'Tooth anatomy'], 'conditions': ['Tooth Abnormalities', 'Tooth Abnormality', 'Tooth Anatomy', 'Tooth Development Disorder', 'Tooth Disorder']}, 'descriptionModule': {'briefSummary': 'The aim of this cross-sectional study is to assess the number of roots in permanent teeth. For this reason, researchers will conduct an analysis of CBCT scans. The collected data will be used for epidemiological analysis, including an examination of differences in outcomes between male and female patients.', 'detailedDescription': 'This study will involve analysis of anonymised CBCT images from Polish dental imaging facility. The analysis will include patients whose scans were obtained previously for diagnostic and therapeutic reasons and do not show significant artefacts. The primary outcome will be defined as the number of roots of each of the assessed teeth. Statistical analysis will be conducted in subgroups based on tooth type, patient gender, and patient age. This study has been approved by the bioethics committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'General population of patients referred for CBCT for diagnostic or therapeutic reasons', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* CBCT scans obtained following a written referral from a dentist,\n* clear and complete visibility of the assessed structure,\n* completed development of assessed roots.\n\nExclusion Criteria:\n\n* incomplete root development in teeth other than third molars within the dentition,\n* CBCT scans with significant artefacts.'}, 'identificationModule': {'nctId': 'NCT07170956', 'briefTitle': 'Analysis of Tooth Root Number', 'organization': {'class': 'OTHER', 'fullName': 'Hospital of the Ministry of Interior, Kielce, Poland'}, 'officialTitle': 'Variability in Tooth Root Number: A Cross-Sectional Study', 'orgStudyIdInfo': {'id': 'CT/2025/1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Females', 'description': 'Female patients'}, {'label': 'Males', 'description': 'Male patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '25-375', 'city': 'Kielce', 'country': 'Poland', 'contacts': [{'name': 'Maciej Sikora, dr hab.', 'role': 'CONTACT', 'email': 'sikora-maciej@wp.pl', 'phone': '+48 41 260 55 85'}], 'facility': 'Department of Maxillofacial Surgery, Hospital of the Ministry of Interior', 'geoPoint': {'lat': 50.87033, 'lon': 20.62752}}], 'centralContacts': [{'name': 'Maciej Sikora, dr hab.', 'role': 'CONTACT', 'email': 'sikora-maciej@wp.pl', 'phone': '+48 41 260 55 85'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital of the Ministry of Interior, Kielce, Poland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}