Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-06 @ 1:46 PM
Study NCT ID:
NCT06791694
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-01-30
First Post:
2025-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Color Measurements of Postgraduate Dental Students Using Different Color Determination Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014075', 'term': 'Tooth Discoloration'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003188', 'term': 'Composite Resins'}], 'ancestors': [{'id': 'D012117', 'term': 'Resins, Synthetic'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D003764', 'term': 'Dental Materials'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'targetDuration': '1 Month', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-28', 'studyFirstSubmitDate': '2025-01-19', 'studyFirstSubmitQcDate': '2025-01-19', 'lastUpdatePostDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To have compared the inter-observer reliability of 4 different methods used in tooth color selection', 'timeFrame': '1 month', 'description': 'To have compared the inter-observer reliability of 4 different methods used in tooth color selection'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['color', 'tooth', 'button'], 'conditions': ['Tooth Discoloration']}, 'descriptionModule': {'briefSummary': 'This study evaluates the accuracy of tooth color identification skills in the anterior region using a new technique, the button technique, in comparison with other methods.', 'detailedDescription': 'The human eye is effective in detecting subtle differences in tooth color. However, variations in the shade, translucency, opacity, and characterization of a tooth may not be accurately identified. Visual color matching is subject to physiological variables that may lead to inconsistencies, such as age, gender, experience, the type of scale used, varying degrees of light exposure, eye fatigue, and color vision deficiency.\n\nStudies comparing visual and instrumental methods have demonstrated that spectrophotometers yield better results compared to visual color scales. Therefore, it is expected that color measurement devices improve the accuracy of tooth color determination, thereby enhancing the interpretation and aesthetic execution of restorations.\n\nIn recent years, the button technique has been described for shade selection in direct aesthetic restorations in the anterior region. In this technique, small composite samples in the form of dots are polymerized on the tooth surface using a curing light. Digital photographs are then taken, and appropriate enamel and dentin shades are selected on a computer using polarized and black-and-white images.\n\nVery few clinical studies have investigated the use of digital color images obtained through intraoral digital scanners for shade selection, comparing them with other existing methods.\n\nThe aim of this study is to evaluate the accuracy of shade determination skills in the anterior region by comparing a new technique, the button technique, with other methods and to recommend the most suitable method for shade selection'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Being healthy individuals, not having any systemic diseases, being young individuals (18-40 age range)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being healthy individuals,\n* Not having any systemic diseases,\n* Being young individuals (18-40 age range)\n* Vital, decay-free and healthy upper central teeth,\n* Absence of caries-free hard tissue abrasions, any restoration, fracture, crack, intrinsic or extrinsic discoloration in the upper central teeth\n* Lack of removable prosthesis feet for central teeth\n\nExclusion Criteria:\n\n* Tetracycline, fluorosis staining of upper central teeth\n* Patients with dentin exposure or loss of bine in the upper central teeth for any reason\n* Pregnant and lactating patients will not be included.'}, 'identificationModule': {'nctId': 'NCT06791694', 'acronym': 'Color', 'briefTitle': 'Comparison of Color Measurements of Postgraduate Dental Students Using Different Color Determination Methods', 'organization': {'class': 'OTHER', 'fullName': 'Hacettepe University'}, 'officialTitle': 'Comparison of Color Measurements of Postgraduate Dental Students in the Maxillary Anterior Region Using Different Color Determination Methods', 'orgStudyIdInfo': {'id': 'KA-21049'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Resins, Composite', 'type': 'OTHER', 'otherNames': ['vita classical', 'Vita 3D master', 'spectrophotometer'], 'description': 'Graduate students; healthy maxillary central teeth and color measurements will be performed with 4 different methods in at least 32 patients aged between 18-40 years. Firstly, students will be asked to make color measurements using the traditional method with two different color scales (Vita classical and Vita 3D master). As the third method; the enamel color of the teeth will be determined on digital photographs using the buton technique. Finally, tooth color will be measured on the buccal surface of the central teeth using a spectrophotometer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Altındağ', 'state': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Hacettepe University', 'geoPoint': {'lat': 39.96673, 'lon': 32.92254}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hacettepe University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Asisstant', 'investigatorFullName': 'Kemal Işıklı', 'investigatorAffiliation': 'Hacettepe University'}}}}