GenderCPDNCT02884856
Color Perception in Dentistry (CPD)
An observational study of Gender, run by Universidade de Passo Fundo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Gender
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2014to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Dental students from University of Passo Fundo (Brazil) and with some knowledge and clinical experience with shade matching will be included in the study.
Who may be able to join
- Dental students (DS) from University of Passo Fundo.
- DS with some knowledge and clinical experience with shade matching.
- DS from 20 to 35 years old.
Who cannot join
- DS with abnormal color vision.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99052-900
About this study
Official title: Influence of Gender on Visual Shade Matching in Dentistry
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.
The 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.
Read the detailed description
- Female and male observers will be analyzed.
- Human upper central incisors (UCI) will be shade matched to shade tabs from Vita Classical (VC) shade guide.
- The spectral reflectances from the four UCI and from the 16 VC shade tabs will be measured using a spectroradiometer (SP).
- Measurements will be performed over a gray background, inside a viewing booth and under D65 illuminant (diffuse/0º geometry).
- CIELAB coordinates (L*, a* and b*) will be calculated according to CIE D65 illuminant and CIE 2º Standard Observer.
- 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.
- Data will be analyzed using descriptive statistics and McNemar test (α=0.05).
- Conditions
- Gender
- Keywords
- color, dentistry, gender
- Medical subject headings
- Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Females observers (F) | those with female gender characteristics | |
| Male observers (M) | those with male gender characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gender effect on visual shade matching
Measured: The study last for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startAug 2014
- Primary completionDec 2014
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for GenderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Passo Fundo
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Ministerio de Economía y Competitividad, Spain, Universidad de Granada
- Responsible party
- Principal investigator, Alvaro Della Bona, Universidade de Passo Fundo
- Investigators
- Alvaro Della Bona, Ph.D., Study director, Universidade de Passo FundoOscar E. Pecho, Ph.D., Principal investigator, Universidade de Passo Fundo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02884856
- Sponsor's protocol ID
- 34553314.0.0000.5342
- Acronym
- CPD
- Status last verified
- Aug 2016
- First submitted
- 22 Aug 2016
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22943488Capa 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.
PubMed 20045824Deeb 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.
PubMed 15811001Della 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.
PubMed 19019420Donahue 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.
PubMed 2051396Haddad 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.
PubMed 19520478Hugo 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.
PubMed 16215749Milagres 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.
PubMed 22335300Paul 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.
PubMed 12147751Pecho 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.
PubMed 26631341
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Gender on Visual Shade Matching in Dentistry
- ClinicalTrials.gov ID
- NCT02884856
- Acronym / sponsor ID
- CPD / 34553314.0.0000.5342
- Conditions
- Gender
- Keywords
- color, dentistry, gender
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universidade de Passo FundoUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Ministerio de Economía y Competitividad, Spain, Universidad de Granada
- Study start
- Aug 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
The 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.
Detailed description
- Female and male observers will be analyzed.
- Human upper central incisors (UCI) will be shade matched to shade tabs from Vita Classical (VC) shade guide.
- The spectral reflectances from the four UCI and from the 16 VC shade tabs will be measured using a spectroradiometer (SP).
- Measurements will be performed over a gray background, inside a viewing booth and under D65 illuminant (diffuse/0º geometry).
- CIELAB coordinates (L*, a* and b*) will be calculated according to CIE D65 illuminant and CIE 2º Standard Observer.
- 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.
- Data will be analyzed using descriptive statistics and McNemar test (α=0.05).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Females observers (F) | – | –those with female gender characteristics |
| Male observers (M) | – | –those with male gender characteristics |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Dental students from University of Passo Fundo (Brazil) and with some knowledge and clinical experience with shade matching will be included in the study.
Key inclusion criteria (3 listed)
- Dental students (DS) from University of Passo Fundo.
- DS with some knowledge and clinical experience with shade matching.
- DS from 20 to 35 years old.
Key exclusion criteria (1 listed)
- DS with abnormal color vision.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gender effect on visual shade matching
Time frame: The study last for 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Background: PubMed 22943488Abramov 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.
- Background: PubMed 20045824Capa 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.
- Background: PubMed 15811001Deeb 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.
- Background: PubMed 19019420Della 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.
- Background: PubMed 2051396Donahue 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.
- Background: PubMed 19520478Haddad 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.
- Background: PubMed 16215749Hugo 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.
- Background: PubMed 22335300Milagres 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.
- Background: PubMed 12147751Paul 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.
- Results publication: PubMed 26631341Pecho 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alvaro Della Bona, Ph.D. study director
Universidade de Passo Fundo
Oscar E. Pecho, Ph.D. principal investigator
Universidade de Passo Fundo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gender, run by Universidade de Passo Fundo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gender effect on visual shade matching (time frame: The study last for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02884856, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2016.