Study on the Chromatic Perception of Digital Systems in Aesthetic Field

May 2, 2025 updated by: Paolone Gaetano

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milano, Italy, 20132
        • IRCCS San Raffaele

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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).

Description

Inclusion Criteria:

  • Patients with good oral health
  • Age over 18 years old
  • Signing of an informed consent form according to the protocol

Exclusion Criteria:

  • Any type of restoration on the upper central and lateral incisors

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other: oral photography
The patient will under go three different color detecting methods. Two photography methodologies and one intra oral digital scanner
Other Names:
  • digital intra oral scanner
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
Other: oral photography
The patient will under go three different color detecting methods. Two photography methodologies and one intra oral digital scanner
Other Names:
  • digital intra oral scanner
Group 3
This group will include patients with an age over 60 years old. The recruitment doesn't include a gender selection
Other: oral photography
The patient will under go three different color detecting methods. Two photography methodologies and one intra oral digital scanner
Other Names:
  • digital intra oral scanner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paolone Gaetano

Investigators

  • Principal Investigator: Paolone Gaetano, IRCCS San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 27, 2025

Primary Completion (Actual)

April 15, 2025

Study Completion (Actual)

April 15, 2025

Study Registration Dates

First Submitted

March 28, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 4, 2024

Study Record Updates

Last Update Posted (Actual)

May 7, 2025

Last Update Submitted That Met QC Criteria

May 2, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • VF-ES-DIG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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