Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:40 AM
Study NCT ID:
NCT07375368
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-29
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of a 3D-Printed Extraoral Camera Assembly for Standardized Dental Photography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-24', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-24', 'lastUpdatePostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference between photographic and actual tooth dimensions (assembly vs standard)', 'timeFrame': 'through study completion, an average of 2 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3D-printed extraoral camera', 'standardization', 'extraoral camera'], 'conditions': ['Imaging']}, 'descriptionModule': {'briefSummary': 'This study investigates whether a 3D-printed extraoral camera assembly improves the reproducibility and dimensional standardization of dental photographs compared with conventional DSLR photography using standardized settings. The assembly, serving as the index test, standardizes camera position, distance, and angle during image capture, allowing performance comparison with traditional DSLR methods under identical exposure and lighting conditions. By enhancing photographic consistency, the assembly aims to improve longitudinal periodontal records, esthetic documentation, and digital analyses, providing a non-contact, operator-independent tool for reliable visual comparisons across clinical sessions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include adult volunteers aged 18-40 years with intact anterior dentition and healthy periodontal tissues, who are cooperative and able to maintain a standardized head position during imaging. Only intraoral photographs will be captured. Exclusion criteria comprise individuals with facial deformities or scars affecting the photographic region, those who have undergone orthognathic or periodontal plastic surgery altering soft-tissue contours, and participants with active dermatologic lesions or tattoos in the perioral area.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult volunteers aged 18-40 years.\n* Intact anterior dentition and healthy periodontal tissues.\n* Cooperative and able to maintain a standardized head position. Only intraoral photographs will be taken\n\nExclusion Criteria:\n\n* Facial deformities or scars affecting the image region.\n* Previous orthognathic or periodontal plastic surgery altering soft-tissue contour.\n* Active dermatologic lesions or tattoos in the perioral area.'}, 'identificationModule': {'nctId': 'NCT07375368', 'briefTitle': 'Assessment of a 3D-Printed Extraoral Camera Assembly for Standardized Dental Photography', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Evaluation of a 3D-Printed Extraoral Camera Assembly for Standardization of Dental Photography:A Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': '10.25'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer, Department of Periodontology Faculty of Dentistry, Cairo University', 'investigatorFullName': 'Ghada Adayil', 'investigatorAffiliation': 'Cairo University'}}}}