Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT07133503
Status:
COMPLETED
Last Update Posted:
2025-08-21
First Post:
2025-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiological Evaluation of Anterior Maxilla For Immediate Implant Placement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063173', 'term': 'Retrognathia'}], 'ancestors': [{'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-01', 'size': 361847, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-18T03:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 278}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-18', 'studyFirstSubmitDate': '2025-07-22', 'studyFirstSubmitQcDate': '2025-08-18', 'lastUpdatePostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Alveolar Crest Height', 'timeFrame': 'One year', 'description': "The height of the alveolar crest was defined as the length of a line drawn parallel to the crest's long axis between the nasal fossa floor and the alveolar crest."}, {'measure': 'Alveolar Crest Width', 'timeFrame': 'One year', 'description': 'The width of the alveolar crest was calculated by averaging measurements taken from the midpoints of three equal sections of the alveolar crest.'}, {'measure': 'Buccal Bone Thickness', 'timeFrame': 'One year', 'description': 'To determine buccal bone thickness, measurements were taken from the buccal crest apex, the midpoint of the root, and the apex of the tooth.'}, {'measure': 'Buccal Undercut Depth', 'timeFrame': 'One year', 'description': 'The buccal undercut was determined as the point where the crest came closest to the root in the sagittal plane.'}, {'measure': 'Root Position', 'timeFrame': 'One year', 'description': 'the angle between the tooth roots and the alveolar crest was measured to determine the root position in the radial plane'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate implant applications', 'Cone-beam computed tomography', 'Anterior maxilla', 'Alveolar ridge morphology', 'Aging'], 'conditions': ['Maxillary Retrusion']}, 'descriptionModule': {'briefSummary': 'According to the literature age and gender may be associated with differences in skeletal size, anatomy and architecture in humans. However, little is known about the synergistic effects of age and gender on the healing capacity of maxillary bones, since most of the preclinical studies are focused on each variable separately. The present study radiologically evaluated various parameters such as alveolar crest height and width, buccal bone thickness, degree of buccal undercut, and root-crest angle using cone-beam computed tomography (CBCT) in a large patient population, and compared these parameters across different age and gender groups to analyze the effect of aging and gender on the bone morphology in the anterior maxillary region.', 'detailedDescription': 'Aim: The aim of this present study was to radiologically evaluate the socket morphology that may have a clinical impact on the outcomes of immediate implant placement in the anterior maxilla, using cone-beam computed tomography (CBCT) in a large patient population. Moreover, the parameters were compared between different age and gender groups to analyze the effect of aging and gender on the bone morphology around the maxillary anterior teeth.\n\nMaterial and Methods: This study evaluated a total of 1,668 teeth in the esthetic region, including bilateral central incisors, lateral incisors, and canines in the upper anterior region, using CBCT images from 278 individuals. CBCT images were grouped into age ranges of 20-29, 30-39, 40-49, 50-59, 60-69, and 70-80 years. The morphology of the anterior ridge was assessed by separately measuring alveolar ridge width and height, buccal bone thickness, tooth-crest angle, and buccal undercut for maxillary central incisors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cone-beam coemputed tomography (CBCT) images of individuals, obtained for various diagnostic purposes at the Erciyes University Faculty of Dentistry, Oral and Maxillofacial Radiology Clinic between January 2015 and January 2024', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Between January 2015 and January 2024, undergoing CBCT imaging at the Erciyes University Faculty of Dentistry, Department of Oral and Maxillofacial Radiology\n\nExclusion Criteria:\n\n* Systemic diseases,\n* Anterior maxillary tooth loss,\n* Having root canal treatments,\n* Periapical lesions,\n* History of or ongoing periodontal disease,\n* Smoking.'}, 'identificationModule': {'nctId': 'NCT07133503', 'briefTitle': 'Radiological Evaluation of Anterior Maxilla For Immediate Implant Placement', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'Evaluation of Buccal Bone Thickness, Ridge Dimensions, And Root Position In Anterior Maxilla For Immediate Implant Placement', 'orgStudyIdInfo': {'id': 'EU2020/470'}}, 'armsInterventionsModule': {'armGroups': [{'label': '20-29 age group', 'description': 'In this age group bilateral central incisors, lateral incisors, and canines in the upper anterior region were examined', 'interventionNames': ['Other: radiological evaluation']}, {'label': '30-39 age group', 'description': 'In this age group bilateral central incisors, lateral incisors, and canines in the upper anterior region were examined', 'interventionNames': ['Other: radiological evaluation']}, {'label': '40-49 age group', 'description': 'In this age group bilateral central incisors, lateral incisors, and canines in the upper anterior region were examined', 'interventionNames': ['Other: radiological evaluation']}, {'label': '50-59 age group', 'description': 'In this age group bilateral central incisors, lateral incisors, and canines in the upper anterior region were examined', 'interventionNames': ['Other: radiological evaluation']}, {'label': '60-69 age group', 'description': 'In this age group bilateral central incisors, lateral incisors, and canines in the upper anterior region were examined', 'interventionNames': ['Other: radiological evaluation']}, {'label': '70-80 age group', 'description': 'In this age group bilateral central incisors, lateral incisors, and canines in the upper anterior region were examined', 'interventionNames': ['Other: radiological evaluation']}], 'interventions': [{'name': 'radiological evaluation', 'type': 'OTHER', 'description': "Using a line drawn through the midpoints of the teeth, parallel to their long axes, the anterior crest morphology was assessed. For maxillary central, lateral, and canine teeth, alveolar crest width and height, buccal bone thickness, and tooth-crest angle were measured separately. To determine buccal bone thickness, measurements were taken from the buccal crest apex, the midpoint of the root, and the apex of the tooth. The height of the alveolar crest was defined as the length of a line drawn parallel to the crest's long axis between the nasal fossa floor and the alveolar crest. The width of the alveolar crest was calculated by averaging measurements taken from the midpoints of three equal sections of the alveolar crest. The buccal undercut was determined as the point where the crest came closest to the root in the sagittal plane. Additionally, the angle between the tooth roots and the alveolar crest was measured to determine the root position in the radial plane", 'armGroupLabels': ['20-29 age group', '30-39 age group', '40-49 age group', '50-59 age group', '60-69 age group', '70-80 age group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Kayseri', 'state': 'Kayseri̇', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University Faculty of Dentistry Department of Periodontology', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}, {'zip': '38000', 'city': 'Kayseri', 'state': 'Melikgazi', 'country': 'Turkey (Türkiye)', 'facility': 'Erciyes University', 'geoPoint': {'lat': 38.73222, 'lon': 35.48528}}], 'overallOfficials': [{'name': 'Duygu Kilic', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TC Erciyes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Duygu Kilic', 'investigatorAffiliation': 'TC Erciyes University'}}}}