- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07781839
Evaluation of Different Color Determination Methods
In Vivo Evaluation of Different Color Determination Methods for Accuracy and Reproducibility
With the increasing aesthetic demands in dental practice, the accuracy and consistency of tooth color determination methods have gained importance for clinical success. This study aims to compare different tooth color determination methods in terms of accuracy and repeatability under in vivo conditions. A spectrophotometric system (VITA Easyshade V) will be used as the reference method. In comparison, the results obtained through visual assessment by observers, a digital intraoral scanner (TRIOS 3), and artificial intelligence-based color analysis systems will be evaluated. Statistical analyses will be conducted based on ΔE, L*, a*, b*, and shade code data obtained from the measurements, and the agreement among the methods as well as their correlations with the spectrophotometer will be examined. This study aims to demonstrate the clinical validity of digital and AI-assisted methods and to emphasize the importance of objective approaches in tooth shade selection.
The aim of this study is to compare four different tooth color determination methods used in aesthetic dentistry-spectrophotometric system, observer-based visual assessment, digital intraoral scanner, and artificial intelligence-assisted analysis system-in terms of accuracy and repeatability under in vivo conditions. The study seeks to statistically evaluate and compare the color measurement values obtained from these methods with those of the spectrophotometric system, which is considered the reference method, and to determine the level of agreement among the methods. In addition, it aims to assess the clinical applicability and reliability of digital technologies and artificial intelligence-based systems in tooth color selection.
Study Overview
Status
Conditions
Detailed Description
This analytical cross-sectional clinical study was conducted between May 2025 and June 2025 at the Department of Prosthodontics, Faculty of Dentistry, Necmettin Erbakan University. The study aims to demonstrate the clinical validity of digital and artificial intelligence-assisted methods and to contribute to emphasizing the importance of objective approaches in tooth shade selection.
A total of 40 adult participants with healthy maxillary central incisors were included in the study.
Color measurements will be taken from the middle third of the labial surface of each participant's maxillary central incisor. All measurements will be performed by the same clinician, in a fixed position, and under standardized lighting conditions.
Color Determination Methods:
Spectrophotometric Measurement:
The VITA Easyshade V spectrophotometer will be used as the reference method. The device will be calibrated before each use, and measurements will be taken in a perpendicular position to the tooth surface. VITA 3D Master shade values as well as L*, a*, and b* parameters will be recorded.
Visual Assessment:
Observer-based visual evaluation will be performed using the VITA 3D Master shade guide. To minimize visual bias, the evaluation time will be limited to 10 seconds, and the selected shade values will be converted into the CIE Lab* color system.
Digital Intraoral Scanner:
The TRIOS 3 digital intraoral scanner will be used for image acquisition following device calibration. The color values obtained from the scans will be recorded.
- Artificial Intelligence-Assisted Color Analysis:
Photographs of the teeth will be taken in RAW format under natural light, from a fixed distance, and against a neutral gray background. After preprocessing, the images will be analyzed using a specially trained image-processing model based on artificial intelligence.
Data Analysis:
The color values obtained from each method will be compared with those from the spectrophotometric measurements. Color differences will be calculated using the ΔE formula. One-way ANOVA and Bonferroni post-hoc tests will be employed to evaluate differences among the methods. The agreement between L*, a*, and b* values will be analyzed using Kendall's tau-b correlation analysis, while the consistency of shade code matching will be assessed using Cohen's Kappa statistics. All data will be processed and evaluated using an appropriate statistical analysis software program.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Selçuklu
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Konya, Selçuklu, Turkey (Türkiye), 42090
- Necmettin Erbakan Üniversity
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 years or older
- Absence of restorations, discoloration, or structural defects on the maxillary central incisors
- Willingness to undergo digital measurement and clinical evaluation
Exclusion Criteria:
- Presence of restorations or discoloration on the anterior teeth
- Existence of structural defects, malposition, or enamel hypoplasia
- History of orthodontic or prosthodontic treatment
- Individuals with systemic diseases or a history of psychiatric or neurological disorders
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Spectrophotometric Shade Selection
Time Frame: baseline
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After calibration according to the manufacturer's instructions, the spectrophotometer will be used to determine the shade from the middle third of the maxillary central incisor.
The color difference between the L*, a*, and b* values obtained from each group and the reference measurement will be calculated using the CIEDE2000 (ΔE00) formula.
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baseline
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Neu2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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