NCT07397546

Brief Summary

Achieving an accurate shade match is a critical factor in the success of anterior esthetic restorations, directly influencing patient satisfaction, perceived treatment success, and long-term acceptance of restorations. Tooth color is a complex, multidimensional phenomenon influenced by hue, chroma, value, translucency and surface texture, and small discrepancies can be easily perceived in the esthetic zone. Traditionally, shade selection has been performed visually using commercial shade guides such as the VITA Classical or VITA 3D-Master systems. However, visual shade matching is inherently subjective and is significantly affected by examiner experience, training, surrounding environment, light source, observer fatigue, and metamerism. Several studies have shown that visual methods demonstrate only mild-to-moderate reliability and agreement, even among trained clinicians and students. To overcome these limitations, digital spectrophotometers were introduced to provide objective, reproducible, CIELAB-based color measurements of natural teeth and restorations. These devices analyze reflected light within a defined wavelength range and express the tooth shade within established systems such as VITA Classical A1-D4 and VITA 3D- Master. They have been widely used as an instrumental "gold standard" against which visual shade selection is evaluated, consistently demonstrating higher accuracy and better repeatability than conventional visual methods. More recently, artificial intelligence (AI) and machine learning (ML) approaches have been explored for dental shade matching. Deep learning models based on convolutional neural networks and other ML algorithms can analyze standardized intraoral photographs or smartphone images to automatically classify tooth shades according to VITA shade systems, often showing promising accuracy, precision and F1-scores, comparable to or sometimes exceeding experienced clinicians. In vitro studies have started to compare AI-based shade matching applications with spectrophotometers and image-based photometric analysis, suggesting that although spectrophotometers still tend to provide the most accurate color match, AI systems are rapidly improving and may offer clinically acceptable results with advantages in speed, usability, and integration into digital workflows. However, most of these investigations have been conducted using laboratory setups, artificial teeth, or non-Egyptian populations, and there remains a scarcity of in vivo diagnostic-accuracy studies validating AI shade selection systems against an accepted instrumental standard in real clinical settings

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
268

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Mar 2026

Shorter than P25 for all trials

Status
not yet recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress28%
Mar 2026Nov 2026

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Expected
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2 months

First QC Date

February 2, 2026

Last Update Submit

February 6, 2026

Conditions

Keywords

AI Assisted Shade selectionDigital spectrophotometryDiagnostic Accuracy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of shade match in maxillary anterior teeth.

    accuracy will be evaluated by comparing the index test ( AI assisted software) to the Reference test ( Digital Spectrophotometer).

    1 Day

Study Arms (1)

shade selection of the patients attending the outpatient clinic

* Age: 18-65 years. * Male or female. * Good oral hygiene * Co-operative patients approving to participate in the trial. * Have sufficient congnitive ability to understand consent procedure. * Maxillary anterior teeth * No signs of clinical mobility. * Teeth with healthy periodontium.

Diagnostic Test: Shade selection

Interventions

Shade selectionDIAGNOSTIC_TEST

The study will utilize digital spectrophotometry (VITA Easyshade®, Zahnfabrik H. Rauter GmbH \& Co. KG) as the reference standard, and an Artificial Intelligence-based shade selection system as the index test for determining the shade of maxillary anterior teeth in adult Egyptian patients. All enrolled participants will undergo both tests during the same visit to allow direct comparison between AI shade prediction and spectrophotometric measurement. The reference standard will be applied using a standardized clinical protocol because spectrophotometry is widely regarded as the instrumental "gold standard" for objective tooth color measurement in addition to objective color coordinates when available.

shade selection of the patients attending the outpatient clinic

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study will be conducted in the outpatient clinic of Conservative Dentistry Department, Faculty of Dentistry, Cairo University.

You may qualify if:

  • Age: 18-65 years.
  • Male or female.
  • Good oral hygiene
  • Co-operative patients approving to participate in the trial.
  • Have sufficient congnitive ability to understand consent procedure.
  • Maxillary anterior teeth
  • No signs of clinical mobility.
  • Teeth with healthy periodontium.

You may not qualify if:

  • Patients with orthodontic appliances, or bridge work that might interfere with evaluation.
  • Systematic disease that may affect participation.
  • Non-vital tooth.
  • Signs of pathological wear.
  • Endodontically treated teeth.
  • Severe periodontal affection or tooth
  • indicated for extraction.
  • Missing anterior teeth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Lee, J.H. and Kim, H.K. (2024) "A comparative study of shade-matching performance using intraoral scanner, spectrophotometer, and visual assessment," Scientific Reports, 14(1). Available at: https://doi.org/10.1038/s41598-024-74354-z.

    BACKGROUND
  • Diamantopoulou, S. and Papazoglou, E. (2026) "Coverage Error of Three Shade Guides to Vital Unrestored Maxillary Anterior Teeth in a Greek Population," Applied Sciences (Switzerland), 16(1). Available at: https://doi.org/10.3390/app16010393.

    BACKGROUND
  • Hashem, B., Khairy, M. and Shaalan, O. (2023) "Evaluation of shade matching of monochromatic versus polychromatic layering techniques in restoration of fractured incisal angle of maxillary incisors: A randomized controlled trial," Journal of International Oral Health, 15(1), pp. 43-51. Available at: https://doi.org/10.4103/jioh.jioh_176_22.

    BACKGROUND

Central Study Contacts

Faculty of Dentistry, Cairo University Faculty of Dentistry, Cairo University

CONTACT

Study Design

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

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start

March 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02