Intervening Factors in Tooth Color Assessment
1 other identifier
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2018
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
April 30, 2018
CompletedStudy Start
First participant enrolled
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 4, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2018
CompletedJune 4, 2018
May 1, 2018
2 months
April 30, 2018
May 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Agreement between operators in tooth color assessment with visual shade guides
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
Sequencial; repeated before and 1 week after intervention
Study Arms (1)
Dental prophylaxis
EXPERIMENTALVisit 1: tooth color assessment (by patient, dentist and spectrophotometer) and professional dental prophylaxis Visit 2: tooth color assessment (by patient, dentist and spectrophotometer)
Interventions
Professional dental prophylaxis including dental scaling and dental polishing with prophylactic paste
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 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 using SpectroShade (dental spectrophotometer). Color will be registered in VITA Classical and VITA Toothguide 3D Master and CIELab parameters
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant patients
- Patients subjected to professional dental prophylaxis in less than 4 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculdade de Medicina Dentária, Universidade de Lisboa
Lisbon, 1600-277, Portugal
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Duarte S Marques, PhD, DDS
Grupo de Investigação em Bioquímica e Biologia Oral
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Neither the patient, the investigator that made the color acquisition or the spectrophotometer had knowledge of tooth color assessed by the other person/method
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2018
First Posted
June 4, 2018
Study Start
June 1, 2018
Primary Completion
July 30, 2018
Study Completion
July 30, 2018
Last Updated
June 4, 2018
Record last verified: 2018-05