Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03430713
Other study ID # I2018-02
Secondary ID
Status Completed
Phase N/A
First received February 6, 2018
Last updated March 1, 2018
Start date January 2017
Est. completion date May 2017

Study information

Verified date March 2018
Source Grupo de Investigação em Bioquímica e Biologia Oral
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date May 2017
Est. primary completion date March 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Grupo de Investigação em Bioquímica e Biologia Oral

Outcome

Type Measure Description Time frame Safety issue
Primary 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
See also
  Status Clinical Trial Phase
Completed NCT06355999 - Levari Exp.20: 2D - Partial Feedback N/A
Terminated NCT02925884 - Effects of Gunnar Computer Glasses on Viewing Comfort and Performance N/A
Completed NCT02464241 - Evaluation of Different Color Vision Tests in Children
Completed NCT04836286 - Determining the Impact of Emotive Intelligent Spaces N/A