Intervening Factors in Tooth Color Assessment

Tooth Color Clinical Trial

Official title:

Intervening Factors in Tooth Color Assessment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03544658
• Other study ID #: BL 16000
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 30, 2018

Study information

• Verified date: May 2018
• Source: Grupo de Investigação em Bioquímica e Biologia Oral
• Contact: Daniela C Corado, DDS
• Phone: (+351) 912388159
• Email: daniela-corado[@]campus.ul.pt
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 30, 2018
• Est. primary completion date: July 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tooth Color

Intervention

Procedure:
• Dental prophylaxis
Professional dental prophylaxis including dental scaling and dental polishing with prophylactic paste
• 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
• 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
• 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

Locations

Country	Name	City	State
Portugal	Faculdade de Medicina Dentária, Universidade de Lisboa	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Grupo de Investigação em Bioquímica e Biologia Oral	University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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
Secondary	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