Different methods of colour evaluation between the human eye and a digital instrument
| ISRCTN | ISRCTN85216751 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85216751 |
| Secondary identifying numbers | COL1 |
- Submission date
- 12/05/2024
- Registration date
- 20/05/2024
- Last edited
- 20/05/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
The subjective nature of visually determining tooth shade is an issue for dentists. Several instruments have been used in the hope of achieving more consistent and reliable shade selection. However, the best method remains a topic of debate. The aim of this study is to investigate the accuracy of a recently introduced colorimeter and compare its ability in shade matching with human vision.
Who can participate?
Students of the University of Genoa or dental collaborators of the university
What does the study involve?
The study involves examining several composite discs and trying to match the colour of the test discs with the control discs.
What are the possible benefits and risks of participating?
The benefit is screening for eventual color blindness. No risks are expected.
Where is the study run from?
University of Genoa (Italy)
When is the study starting and how long is it expected to run for?
December 2023 to April 2024
Who is funding the study?
University of Genoa (Italy)
Who is the main contact?
Paolo Pesce, Paolo.pesce@unige.it
Contact information
Public, Scientific, Principal Investigator
Largo Rosanna Benzi
Genoa
16100
Italy
| Phone | +39 (0)103537421 |
|---|---|
| paolo.pesce@unige.it |
Study information
| Study design | Observational cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Dental clinic |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Dental colour matching ability: comparison between visual determination and technology |
| Study hypothesis | To compare the accuracy of a recently introduced colorimeter in shade matching with human vision. In addition, possible variables affecting color-matching by human eye have been analysed. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | This study was assessed by the authors to be very low risk and as such approval by the ethics committee was not required |
| Condition | Dental color matching |
| Intervention | 18 disc-shaped composite samples with identical size and shape were produced from a composite flow system (Enamel plus HriHF, Micerium): 9 were considered control samples (UD 0-UD 6) and 9 were test samples with identical flow composite shade to the control ones. Parallelly, 70 individuals (dental students and dental field professionals) were individually instructed to sit in a dark room illuminated with D55 light and perform visual shade matching between control and test discs. An error matrix containing ΔE94 between control and test discs was generated, containing four match-clusters depending on perceptibility and acceptability thresholds. The frequency and severity of errors were examined for both the colorimeter and the test subjects, considering variables such as age, gender, experience. Folded F-test has been computed for capturing any difference in the number of matches and the Satterthwaite t-test has been used to identify differences among Optishade and visual determination. |
| Intervention type | Device |
| Pharmaceutical study type(s) | Not Applicable |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Colorimeter |
| Primary outcome measure | The frequency of right matches among the test and control colours, obtained once for each participant |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/12/2023 |
| Overall study end date | 01/04/2024 |
Eligibility
| Participant type(s) | Health professional, Learner/student |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | 70 |
| Total final enrolment | 70 |
| Participant inclusion criteria | 1. Italian dental students from the 5th or 6th academic year, dentists, and dental technicians attending, working at or collaborating with the Dental School of the University of Genova from different branches and dental specializations 2. Aged 18 to 70 years |
| Participant exclusion criteria | Color blindness, according to ISO/TR 28642:2016 standard |
| Recruitment start date | 10/12/2023 |
| Recruitment end date | 15/01/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Genoa
16100
Italy
Sponsor information
University/education
Largo Rosanna Benzi
Genoa
16100
Italy
| Phone | +39 (0)103537421 |
|---|---|
| disc@unige.it | |
| Website | http://www.unige.it/ |
"ROR" |
https://ror.org/0107c5v14 |
Funders
Funder type
University/education
Government organisation / Local government
- Alternative name(s)
- University of Genoa
- Location
- Italy
Results and Publications
| Intention to publish date | 12/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The plan is to publish an article in a peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Paolo Pesce (paolo.pesce@unige.it) |
Editorial Notes
20/05/2024: Study's existence confirmed by University of Genoa.
