Intervening Factors in Tooth Color Assessment

The aim of this study is to evaluate the influence of several factors (light, extrinsic stain removal and operator's experience) in tooth color assessment. Tooth color will be assessed by two different operators with visual shade guides under standardized light conditions and using a light correcting device (Smile Lite) or with a dental spectrophotometer in human subjects. Color measurement will be made before and 1 week after dental prophylaxis.

Study Overview

• Status: Unknown
• Conditions: Tooth Color
• Intervention / Treatment: Procedure: Dental prophylaxis; Procedure: Tooth color assessment by the participant; Procedure: Tooth color assessment by the investigator; Procedure: Tooth color assessment with SpectroShade

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Daniela C Corado, DDS; Phone Number: (+351) 912388159; Email: daniela-corado@campus.ul.pt
• Study Contact Backup: Name: Duarte S Marques, PhD, DDS; Phone Number: (+351) 966486375; Email: duartemd@yahoo.co.uk

Study Locations

• Portugal
  • Lisboa, Portugal, 1600-277
    • Recruiting
    • Faculdade de Medicina Dentária, Universidade de Lisboa
    • Contact: Daniela C Corado, DDS
    • Principal Investigator: Duarte N Marques, PhD, DDS
    • Sub-Investigator: João L Silveira, PhD, DDS
    • Sub-Investigator: Ruben M Pereira, DDS

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:

• Capability to sign the informed consent
• Presence of upper teeth canines and central incisors, free of tooth decay, dental fillings, endodontic treatment or fixed rehabilitation
• Tooth color at least A3 in one of the included teeth
• Teeth should be possible to be subject to tooth color assessment with the predefined methods (color within the visual shade guides range)
• Absence of fixed orthodontic appliances or severe tooth structure anomalies

Exclusion Criteria:

• Pregnant patients
• Patients subjected to professional dental prophylaxis in less than 4 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Dental prophylaxis; Visit 1: tooth color assessment (by patient, dentist and spectrophotometer) and professional dental prophylaxis Visit 2: tooth color assessment (by patient, dentist and spectrophotometer)

Procedure: Dental prophylaxis; Professional dental prophylaxis including dental scaling and dental polishing with prophylactic paste; Procedure: Tooth color assessment by the participant; Tooth color assessment using the VITA Classical shade guide. Assessment will be done with normal light conditions and with a light correcting device; Procedure: Tooth color assessment by the investigator; Tooth color assessment using the VITA Classical shade guide and the VITA Toothguide 3D Master. Assessment will be done with normal light conditions and with a light correcting device; Procedure: Tooth color assessment with SpectroShade; Tooth color assessment using SpectroShade (dental spectrophotometer). Color will be registered in VITA Classical and VITA Toothguide 3D Master and CIELab parameters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tooth color change determined before and after professional dental prophylaxis, assessed with visual shade guide (VITA Classical)	Tooth color will be determined prior to dental prophylaxis by the participant, investigator and spectrophotometer, using visual shade guide VITA Classical. 1 week after the intervention, the tooth color will be determined once again with the same protocol.	1 week (measurements before and 1 week after dental prophylaxis)
Tooth color change measured before and after professional dental prophylaxis, assessed with visual shade guide (VITA Toothguide 3D-Master)	Tooth color will be determined prior to dental prophylaxis by the investigator and dental spectrophotometer, using visual shade guide VITA Toothguide 3D-Master. 1 week after the intervention, the tooth color will be determined once again with the same protocol.	1 week (measurements before and 1 week after dental prophylaxis)
Tooth color change in CIELab system measured before and after professional dental prophylaxis	Tooth color in CIELab system will be determined by the conversion of VITA Classical shade guides in CIELab parameters assessed by the participant and investigator and by the spectroshade prior to professional dental prophylaxis. 1 week after the procedure tooth color will be determined once again with the same protocol.	1 week (measurements before and 1 week after dental prophylaxis)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement between operators in tooth color assessment with visual shade guides	Comparison of tooth colors determined by the participant, investigator and spectrophotometer.	Sequencial; repeated before and 1 week after intervention
Influence of light conditions in tooth color assessment - change between determination with and without a light correcting device	Tooth color determined by the participant and investigator with visual shade guides with two different light conditions: environmental light and assessment with a light correcting device (Smile Lite)	Sequencial; repeated before and 1 week after intervention

Collaborators and Investigators

• Sponsor: Grupo de Investigação em Bioquímica e Biologia Oral
• Collaborators: University of Lisbon
• Investigators: Study Director: Duarte S Marques, PhD, DDS, Grupo de Investigação em Bioquímica e Biologia Oral

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): July 30, 2018
• Study Completion (ANTICIPATED): July 30, 2018

Study Registration Dates

• First Submitted: April 30, 2018
• First Submitted That Met QC Criteria: May 31, 2018
• First Posted (ACTUAL): June 4, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 4, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Dental prophylaxis; Tooth extrinsic stain; Tooth color; Visual shade guide; Dental spectrophotometer
• Other Study ID Numbers: BL 16000

Drug and device information, study documents

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