Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-13 @ 12:46 PM
Study NCT ID:
NCT02884856
Status:
COMPLETED
Last Update Posted:
2016-08-31
First Post:
2016-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Color Perception in Dentistry (CPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003075', 'term': 'Coitus'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-25', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gender effect on visual shade matching', 'timeFrame': 'The study last for 2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['color', 'dentistry', 'gender'], 'conditions': ['Gender']}, 'referencesModule': {'references': [{'pmid': '22943488', 'type': 'BACKGROUND', 'citation': 'Abramov I, Gordon J, Feldman O, Chavarga A. Sex and vision II: color appearance of monochromatic lights. Biol Sex Differ. 2012 Sep 4;3(1):21. doi: 10.1186/2042-6410-3-21.'}, {'pmid': '20045824', 'type': 'BACKGROUND', 'citation': 'Capa N, Malkondu O, Kazazoglu E, Calikkocaoglu S. Evaluating factors that affect the shade-matching ability of dentists, dental staff members and laypeople. J Am Dent Assoc. 2010 Jan;141(1):71-6. doi: 10.14219/jada.archive.2010.0023.'}, {'pmid': '15811001', 'type': 'BACKGROUND', 'citation': 'Deeb SS. The molecular basis of variation in human color vision. Clin Genet. 2005 May;67(5):369-77. doi: 10.1111/j.1399-0004.2004.00343.x.'}, {'pmid': '19019420', 'type': 'BACKGROUND', 'citation': 'Della Bona A, Barrett AA, Rosa V, Pinzetta C. Visual and instrumental agreement in dental shade selection: three distinct observer populations and shade matching protocols. Dent Mater. 2009 Feb;25(2):276-81. doi: 10.1016/j.dental.2008.09.006. Epub 2008 Nov 18.'}, {'pmid': '2051396', 'type': 'BACKGROUND', 'citation': 'Donahue JL, Goodkind RJ, Schwabacher WB, Aeppli DP. Shade color discrimination by men and women. J Prosthet Dent. 1991 May;65(5):699-703. doi: 10.1016/0022-3913(91)90209-f.'}, {'pmid': '19520478', 'type': 'BACKGROUND', 'citation': 'Haddad HJ, Jakstat HA, Arnetzl G, Borbely J, Vichi A, Dumfahrt H, Renault P, Corcodel N, Pohlen B, Marada G, de Parga JA, Reshad M, Klinke TU, Hannak WB, Paravina RD. Does gender and experience influence shade matching quality? J Dent. 2009;37 Suppl 1:e40-4. doi: 10.1016/j.jdent.2009.05.012. Epub 2009 May 22.'}, {'pmid': '16215749', 'type': 'BACKGROUND', 'citation': 'Hugo B, Witzel T, Klaiber B. Comparison of in vivo visual and computer-aided tooth shade determination. Clin Oral Investig. 2005 Dec;9(4):244-50. doi: 10.1007/s00784-005-0014-3. Epub 2005 Oct 8.'}, {'pmid': '22335300', 'type': 'BACKGROUND', 'citation': 'Milagres V, Teixeira ML, Miranda ME, Osorio Silva CH, Ribeiro Pinto JR. Effect of gender, experience, and value on color perception. Oper Dent. 2012 May-Jun;37(3):228-33. doi: 10.2341/10-057-C. Epub 2012 Feb 15.'}, {'pmid': '12147751', 'type': 'BACKGROUND', 'citation': 'Paul S, Peter A, Pietrobon N, Hammerle CH. Visual and spectrophotometric shade analysis of human teeth. J Dent Res. 2002 Aug;81(8):578-82. doi: 10.1177/154405910208100815.'}, {'pmid': '26631341', 'type': 'RESULT', 'citation': 'Pecho OE, Ghinea R, Alessandretti R, Perez MM, Della Bona A. Visual and instrumental shade matching using CIELAB and CIEDE2000 color difference formulas. Dent Mater. 2016 Jan;32(1):82-92. doi: 10.1016/j.dental.2015.10.015. Epub 2015 Nov 28.'}]}, 'descriptionModule': {'briefSummary': 'Visual shade matching (VSM) is the most common procedure to select an adequate shade in dentistry. This clinical procedure requires the use of a shade guide, being Vita Classical (VC) the most popular among the available guides. VSM is a subjective and inconsistent process with many observer related variables (e.g. color deficiency, experience, gender and eye fatigue) that can influence on the final color appearance. The gender influence on the accuracy of VSM is controversial.\n\nThe purpose of this study is to evaluate the VSM performed by female (F) and male (M) students, using VC shade guide, testing the null hypothesis that VSM is not influenced by gender.', 'detailedDescription': '* Female and male observers will be analyzed.\n* Human upper central incisors (UCI) will be shade matched to shade tabs from Vita Classical (VC) shade guide.\n* The spectral reflectances from the four UCI and from the 16 VC shade tabs will be measured using a spectroradiometer (SP).\n* Measurements will be performed over a gray background, inside a viewing booth and under D65 illuminant (diffuse/0º geometry).\n* CIELAB coordinates (L\\*, a\\* and b\\*) will be calculated according to CIE D65 illuminant and CIE 2º Standard Observer.\n* Two color difference metrics (CIELAB and CIEDE2000(2:1:1)) will be used to find the best option for each UCI, using VC shade guide.\n* Data will be analyzed using descriptive statistics and McNemar test (α=0.05).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Dental students from University of Passo Fundo (Brazil) and with some knowledge and clinical experience with shade matching will be included in the study.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dental students (DS) from University of Passo Fundo.\n* DS with some knowledge and clinical experience with shade matching.\n* DS from 20 to 35 years old.\n\nExclusion Criteria:\n\n* DS with abnormal color vision.'}, 'identificationModule': {'nctId': 'NCT02884856', 'acronym': 'CPD', 'briefTitle': 'Color Perception in Dentistry (CPD)', 'organization': {'class': 'OTHER', 'fullName': 'Universidade de Passo Fundo'}, 'officialTitle': 'Influence of Gender on Visual Shade Matching in Dentistry', 'orgStudyIdInfo': {'id': '34553314.0.0000.5342'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Females observers (F)', 'description': 'those with female gender characteristics'}, {'label': 'Male observers (M)', 'description': 'those with male gender characteristics'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99052-900', 'city': 'Passo Fundo', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Universidade de Passo Fundo', 'geoPoint': {'lat': -28.26278, 'lon': -52.40667}}], 'overallOfficials': [{'name': 'Alvaro Della Bona, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universidade de Passo Fundo'}, {'name': 'Oscar E. Pecho, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidade de Passo Fundo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidade de Passo Fundo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}, {'name': 'Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.', 'class': 'OTHER_GOV'}, {'name': 'Ministerio de Economía y Competitividad, Spain', 'class': 'OTHER_GOV'}, {'name': 'Universidad de Granada', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Senior Professor and Researcher', 'investigatorFullName': 'Alvaro Della Bona', 'investigatorAffiliation': 'Universidade de Passo Fundo'}}}}