NCT03430713

Brief 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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2018

Completed
Last Updated

March 2, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

February 6, 2018

Last Update Submit

March 1, 2018

Conditions

Keywords

tooth colormeasurementaccuracyshade guidespectrophotometer

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Dental colour measurement

EXPERIMENTAL

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

Interventions

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.

Dental colour measurement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Duarte Marques, DSD, PhD

    Grupo de Investigação em Bioquímica e Biologia Oral

    STUDY DIRECTOR
  • Rita Alves, DSD

    Grupo de Investigação em Bioquímica e Biologia Oral

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 13, 2018

Study Start

January 1, 2017

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

March 2, 2018

Record last verified: 2018-03

Data Sharing

IPD Sharing
Will not share