Shade MatchNCT07781839
Evaluation of Different Color Determination Methods
An observational study of Shade Match and Intraoral Scanner, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Shade Match, Intraoral Scanner, Artifical Intelligence
- What is being tested?
- Observer-Based Shade Selection, Artificial Intelligence-Based Shade Selection and Digital Intraoral Scanner
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2025to 13 Jun 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: The study was conducted on 40 adult participants with healthy maxillary central incisors. Color measurements were obtained from the middle third of the labial surface of each participant's respective tooth, under standardized lighting conditions and in a fixed position, by the same clinician. All participants were voluntarily recruited from patients who applied to the Department of Prosthodontics, Faculty of Dentistry, Necmettin Erbakan University.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin erbakan university
Konya, Selçuklu, 42090
About this study
Official title: 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.
Read the 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.
- Conditions
- Shade Match, Intraoral Scanner, Artifical Intelligence
- Being tested
- Observer-Based Shade Selection, Artificial Intelligence-Based Shade Selection, Digital Intraoral Scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observer-Based Shade SelectionOther
Occlusal contact area will be calculated as a percentage of the total occlusal surface area in posterior teeth. Digital impressions will be acquired using the Medit i700 intraoral scanner. Contact points will be identified with the Medit Occlusal Analyzer plugin, and contact areas will be measured from STL files using ImageJ software (version 1.54). The percentage will be computed by dividing the total occlusal contact area by the total occlusal surface area. 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.
Artificial Intelligence-Based Shade SelectionOther
Photographs will be taken under natural light conditions, ensuring that both the tooth and the shade guide are visible in the same frame. These images will then be uploaded to the artificial intelligence system for analysis. 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.
Digital Intraoral ScannerOther
Tooth shade selection will be performed on the middle third of the maxillary central incisor using the TRIOS 3 digital intraoral scanner. 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Spectrophotometric Shade Selection
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.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start7 May 2025
- Primary completion7 May 2025
- Study completion13 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shade MatchStudies 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
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Gözen, Konya Necmettin Erbakan Üniversitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781839
- Sponsor's protocol ID
- Neu2025
- Status last verified
- Aug 2026
- First submitted
- 19 Aug 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Evaluation of Different Color Determination Methods for Accuracy and Reproducibility
- ClinicalTrials.gov ID
- NCT07781839
- Acronym / sponsor ID
- Neu2025
- Conditions
- Shade Match, Intraoral Scanner, Artifical Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 7 May 2025 (actual)
- Primary completion
- 7 May 2025 (actual)
- Study completion
- 13 Jun 2025 (actual)
- First posted
- 24 Aug 2026 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study was conducted on 40 adult participants with healthy maxillary central incisors. Color measurements were obtained from the middle third of the labial surface of each participant's respective tooth, under standardized lighting conditions and in a fixed position, by the same clinician. All participants were voluntarily recruited from patients who applied to the Department of Prosthodontics, Faculty of Dentistry, Necmettin Erbakan University.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Observer-Based Shade SelectionOcclusal contact area will be calculated as a percentage of the total occlusal surface area in posterior teeth. Digital impressions will be acquired using the Medit i700 intraoral scanner. Contact points will be identified with the Medit Occlusal Analyzer plugin, and contact areas will be measured from STL files using ImageJ software (version 1.54). The percentage will be computed by dividing the total occlusal contact area by the total occlusal surface area. 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. | Other | – |
| Artificial Intelligence-Based Shade SelectionPhotographs will be taken under natural light conditions, ensuring that both the tooth and the shade guide are visible in the same frame. These images will then be uploaded to the artificial intelligence system for analysis. 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. | Other | – |
| Digital Intraoral ScannerTooth shade selection will be performed on the middle third of the maxillary central incisor using the TRIOS 3 digital intraoral scanner. 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. | Other | – |
Primary outcome
Spectrophotometric Shade Selection
Time frame: baseline
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.
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 24 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Shade Match and Intraoral Scanner, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
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 4 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 24 Aug 2026. 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 Turkey (Türkiye). 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?
Spectrophotometric Shade Selection (time frame: baseline). 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 24 Aug 2026.