Viewing Study NCT02884856


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Study NCT ID: NCT02884856
Status: COMPLETED
Last Update Posted: 2016-08-31
First Post: 2016-08-22
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Color Perception in Dentistry (CPD)
Sponsor: Universidade de Passo Fundo
Organization:

Study Overview

Official Title: Influence of Gender on Visual Shade Matching in Dentistry
Status: COMPLETED
Status Verified Date: 2016-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CPD
Brief 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.
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 Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: