Color Detection of Upper Central IncisorsNCT06346548
Study on the Chromatic Perception of Digital Systems in Aesthetic Field
An observational study of Color Detection of Upper Central Incisors, run by Paolone Gaetano at 1 site in Italy.
Trial summary
The study under consideration aims to evaluate differences in chromatic perception among three distinct color acquisition methodologies. Specifically, recruited patients will undergo testing with three different color detection systems, including two intraoral photography methodologies and one digital intra oral… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Color Detection of Upper Central Incisors
- What is being tested?
- oral photography
- Type of treatment
- Pill or oral medicine
- How many people
- 28 participants
- Where
- 1 siteItaly
- Study dates
- 27 Mar 2025to 15 Apr 2025
- Phase
- Observational
- 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
Study population: As part of normal clinical practice, the expected population for the examination (anticipated number of patients = 78) will undergo three different chromatic detection methodologies to assess differences in chromatic perception through intra and inter group analyses. The selected sample will be divided equally only based on three different age groups (18-29 years, 30-59 years, >60 years).
Who may be able to join
- Patients with good oral health
- Age over 18 years old
- Signing of an informed consent form according to the protocol
Who cannot join
- Any type of restoration on the upper central and lateral incisors
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Monocentric Observational Cross-sectional Study on the Chromatic Perception of Digital Systems in Aesthetic Field
The study under consideration aims to evaluate differences in chromatic perception among three distinct color acquisition methodologies. Specifically, recruited patients will undergo testing with three different color detection systems, including two intraoral photography methodologies and one digital intra oral scanning. All procedures conducted are part of normal clinical practice.
- Being tested
- oral photography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral photographyOther
Also called digital intra oral scanner
The patient will under go three different color detecting methods. Two photography methodologies and one intra oral digital scanner
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | This group will include patients with an age between 18 years old and 29 years old. The recruitment doesn't include a gender selection Receives: Other: oral photography | |
| Group 2 | This group will include patients with an age between 30 years old and 59 years old. The recruitment doesn't include a gender selection Receives: Other: oral photography | |
| Group 3 | This group will include patients with an age over 60 years old. The recruitment doesn't include a gender selection Receives: Other: oral photography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of chromatic values of the upper central incisors
Comparison of chromatic values of the upper central incisors (within and between age groups) extracted from the 3 chromatic detection methodologies(intra oral photography, extra oral photography, intra oral digital scanner), aiming to determine any statistical differences.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study start27 Mar 2025
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Color Detection of Upper Central IncisorsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paolone Gaetano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paolone Gaetano, IRCCS San Raffaele
- Investigators
- Paolone Gaetano, Principal investigator, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06346548
- Sponsor's protocol ID
- VF-ES-DIG
- Status last verified
- May 2025
- First submitted
- 28 Mar 2024
- Last updated
- 7 May 2025
- 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 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Observational Cross-sectional Study on the Chromatic Perception of Digital Systems in Aesthetic Field
- ClinicalTrials.gov ID
- NCT06346548
- Acronym / sponsor ID
- VF-ES-DIG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Paolone GaetanoUniversity, hospital or other
- Study start
- 27 Mar 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 4 Apr 2024 (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.
The study under consideration aims to evaluate differences in chromatic perception among three distinct color acquisition methodologies. Specifically, recruited patients will undergo testing with three different color detection systems, including two intraoral photography methodologies and one digital intra oral scanning. All procedures conducted are part of normal clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: oral photographyThis group will include patients with an age between 18 years old and 29 years old. The recruitment doesn't include a gender selection |
| Group 2 | – | Other: oral photographyThis group will include patients with an age between 30 years old and 59 years old. The recruitment doesn't include a gender selection |
| Group 3 | – | Other: oral photographyThis group will include patients with an age over 60 years old. The recruitment doesn't include a gender selection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- As part of normal clinical practice, the expected population for the examination (anticipated number of patients = 78) will undergo three different chromatic detection methodologies to assess differences in chromatic perception through intra and inter group analyses. The selected sample will be divided equally only based on three different age groups (18-29 years, 30-59 years, >60 years).
Key inclusion criteria (3 listed)
- Patients with good oral health
- Age over 18 years old
- Signing of an informed consent form according to the protocol
Key exclusion criteria (1 listed)
- Any type of restoration on the upper central and lateral incisors
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 |
|---|---|---|
| oral photographyAlso: digital intra oral scannerThe patient will under go three different color detecting methods. Two photography methodologies and one intra oral digital scanner | Other | Group 1, Group 2, Group 3 |
Primary outcome
Comparison of chromatic values of the upper central incisors
Time frame: 9 months
Comparison of chromatic values of the upper central incisors (within and between age groups) extracted from the 3 chromatic detection methodologies(intra oral photography, extra oral photography, intra oral digital scanner), aiming to determine any statistical differences.
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 7 May 2025.
- Individual participant dataSharing planned: No
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.
Paolone Gaetano principal investigator
IRCCS San Raffaele
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Color Detection of Upper Central Incisors, run by Paolone Gaetano at 1 site in Italy.
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 1 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 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Comparison of chromatic values of the upper central incisors (time frame: 9 months). 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 7 May 2025.