NCT07781839

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 7, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 13, 2025

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 19, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 24, 2026

Completed
Last Updated

August 24, 2026

Status Verified

August 1, 2026

Enrollment Period

Same day

First QC Date

August 19, 2026

Last Update Submit

August 19, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Interventions

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.

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.

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Necmettin erbakan university

Konya, Selçuklu, 42090, Turkey (Türkiye)

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Phd

Study Record Dates

First Submitted

August 19, 2026

First Posted

August 24, 2026

Study Start

May 7, 2025

Primary Completion

May 7, 2025

Study Completion

June 13, 2025

Last Updated

August 24, 2026

Record last verified: 2026-08

Locations