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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02884856
Other study ID # 34553314.0.0000.5342
Secondary ID
Status Completed
Phase N/A
First received August 22, 2016
Last updated August 25, 2016
Start date August 2014
Est. completion date June 2016

Study information

Verified date August 2016
Source Universidade de Passo Fundo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in Research
Study type Observational

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date June 2016
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years to 35 Years
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- DS with abnormal color vision.

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
Brazil Universidade de Passo Fundo Passo Fundo Rio Grande do Sul

Sponsors (5)

Lead Sponsor Collaborator
Universidade de Passo Fundo Conselho Nacional de Desenvolvimento Científico e Tecnológico, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Ministerio de Economía y Competitividad, Spain, Universidad de Granada

Country where clinical trial is conducted

Brazil, 

References & Publications (10)

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. — View 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. — View Citation

Deeb SS. The molecular basis of variation in human color vision. Clin Genet. 2005 May;67(5):369-77. Review. — View 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. — View 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. — View 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. — View 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. Epub 2005 Oct 8. — View 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. Erratum in: Oper Dent. 2012 Sep-Oct;37(5):558. Milagres, Viviane [added]; Teixeira, Marcelo Luchesi [added]; Osorio Silva, Carlos Henrique [added]; Ribeiro Pinto, Jose Renato [added]. — View Citation

Paul S, Peter A, Pietrobon N, Hämmerle CH. Visual and spectrophotometric shade analysis of human teeth. J Dent Res. 2002 Aug;81(8):578-82. — View Citation

Pecho OE, Ghinea R, Alessandretti R, Pérez 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gender effect on visual shade matching The study last for 2 years Yes
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