Color PerceptionNCT03430713
Comparison of Visual and Spectrophotometric Methods for Dental Color Measurement - An in Vivo Study
A study testing Measure of tooth color in people with Color Perception and Tooth, run by Grupo de Investigação em Bioquímica e Biologia Oral.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Color Perception, Tooth
- What is being tested?
- Measure of tooth color
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Presence of all upper anterior teeth
- A3 or darker in at least one of those indicated tooth
- Professional dental prophylaxis in last fifteen days
Who cannot join
- Bleaching treatments in last three years
- Orthodontic appliances in indicated tooth
- Presence of caries
- Color changes
- Dental abnormalities
- Internal spots
Show all 9Show fewer
- Anterior restorations
- Anterior crowns
- Anterior veneers
About this study
Official title: Comparison of Visual and Spectrophotometric Methods for Dental Color Measurement - A Pilot Clinical Trial
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
Read the detailed 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.
- Conditions
- Color Perception, Tooth
- Being tested
- Measure of tooth color
- Keywords
- tooth color, measurement, accuracy, shade guide, spectrophotometer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measure of tooth colorProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Measure of tooth color |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2018
- Study startJan 2017
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Color PerceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo de Investigação em Bioquímica e Biologia Oral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duarte Marques, DSD, PhD, Study director, Grupo de Investigação em Bioquímica e Biologia OralRita Alves, DSD, Principal investigator, Grupo de Investigação em Bioquímica e Biologia Oral
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430713
- Sponsor's protocol ID
- I2018-02
- Status last verified
- Mar 2018
- First submitted
- 6 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Visual and Spectrophotometric Methods for Dental Color Measurement - A Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03430713
- Acronym / sponsor ID
- I2018-02
- Conditions
- Color Perception, Tooth
- Keywords
- tooth color, measurement, accuracy, shade guide, spectrophotometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Grupo de Investigação em Bioquímica e Biologia OralUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dental colour measurement | Experimental | Procedure: Measure of tooth colorComparison of dental colour measurement between two shade guides VITA Classical and VITA Toothguide 3D-Master and two spectrophotometers VITA Easyshade and Spectroshade Micro |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Presence of all upper anterior teeth
- A3 or darker in at least one of those indicated tooth
- Professional dental prophylaxis in last fifteen days
Key exclusion criteria (9 listed)
- Bleaching treatments in last three years
- Orthodontic appliances in indicated tooth
- Presence of caries
- Color changes
- Dental abnormalities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measure of tooth colorEvaluation 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. | Procedure or surgery | Dental colour measurement |
Primary outcome
Dental color measurement
Time frame: 2 weeks
Agreement between two clinicians using two dental shade guides and two spectrophotometers in the determination of the colour of maxilary central incisors and canines
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duarte Marques, DSD, PhD study director
Grupo de Investigação em Bioquímica e Biologia Oral
Rita Alves, DSD principal investigator
Grupo de Investigação em Bioquímica e Biologia Oral
Questions about this trial
What is this clinical trial studying?
A study testing Measure of tooth color in people with Color Perception and Tooth, run by Grupo de Investigação em Bioquímica e Biologia Oral.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dental color measurement (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2018.