Comparison of Visual and Spectrophotometric Methods for Dental Color Measurement - An in Vivo Study

Comparison of Visual and Spectrophotometric Methods for Dental Color Measurement - A Pilot Clinical Trial

Twenty patients of Dental Medicine School will be recruited to participate in a pilot study about dental color measurement in which visual and digital instruments will be tested.

Informed consents and local ethical committee clearance will be previously obtained.

All data will be collected after an oral hygiene procedure. Two different methods of color measurement will be tested: visual method with VITA Classical (VC) and VITA 3D-Master (VM) and digital method with Spectroshade Micro (SS) and VITA Easyshade (ES). The CIE L*a*b* values will be evaluated in the VC scale for both methods. Reproducibility will be assessed based on intra-operator intra-device agreement and the accuracy will be assessed based on inter-device agreement using the kappa coefficient (K) and intraclass correlation coefficient (ICC), respectively. Results will be presented as mean, with 95% CI

Study Overview

• Status: Completed
• Conditions: Tooth; Color Perception
• Intervention / Treatment: Procedure: Measure of tooth color

Detailed Description

Clinical practice in Dentistry has been changed during the times, with a large development of aesthetics considerations.

Tooth color is an effect of volume reflection, the passage of incident light through the tooth followed by backward emergence. Color can be categorized in different systems and CIE L*a*b* is the most common. For color acquision visual and digital methods are used.

Tooth shade matching in daily clinical practice is still a cause of disagreement and discomfort for many professionals. The gold standard is the use of dental shade guides by the clinicans who make a comparison between the sample (tooth) and multiple standard guides (shade guide tabs).

The gold standard visual system has been Vitapan Classical (VC). Other system is Toothguide 3D-Master (VM) which applies more closely the accepted color perception concepts of hue, lightness, chroma.

However, several limitations have been associated to visual procedure. The accuracy between clinicians is frequently low and there is a high variability.

For this reason, many improvements in optical electronic devices have led to the expanded use of photometric and colorimetric techniques for the evaluation, specification and management of color.

Although the effectiveness of these devices depends ultimately on the accuracy and precision with which the measurements are carried out.

There is a deeply concern with the determination of the accuracy between different methods for colour acquision because color has to be communicated precisely.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Presence of all upper anterior teeth
• A3 or darker in at least one of those indicated tooth
• Professional dental prophylaxis in last fifteen days

Exclusion Criteria:

• Bleaching treatments in last three years
• Orthodontic appliances in indicated tooth
• Presence of caries
• Color changes
• Dental abnormalities
• Internal spots
• Anterior restorations
• Anterior crowns
• Anterior veneers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dental colour measurement; Comparison of dental colour measurement between two shade guides VITA Classical and VITA Toothguide 3D-Master and two spectrophotometers VITA Easyshade and Spectroshade Micro	Procedure: Measure of tooth color; Evaluation of agreement about measure of tooth color between clinicians using two dental shade guides and two spectrophotometers in the determination of the color of maxilary central incisors and canines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dental color measurement	Agreement between two clinicians using two dental shade guides and two spectrophotometers in the determination of the colour of maxilary central incisors and canines	2 weeks

Collaborators and Investigators

• Sponsor: Grupo de Investigação em Bioquímica e Biologia Oral
• Investigators: Study Director: Duarte Marques, DSD, PhD, Grupo de Investigação em Bioquímica e Biologia Oral; Principal Investigator: Rita Alves, DSD, Grupo de Investigação em Bioquímica e Biologia Oral

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: February 6, 2018
• First Submitted That Met QC Criteria: February 6, 2018
• First Posted (Actual): February 13, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: accuracy; measurement; tooth color; shade guide; spectrophotometer
• Other Study ID Numbers: I2018-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No