ClinicalTrials.gg
RecruitingNCT07707323Updated Jul 16, 2026

Diagnostic Accuracy of Innovative Photo-Analysis Software in Resin Composite Shade Matching

An interventional study of Computer-Assisted Software in Shade Matching, sponsored by Misr University for Science and Technology. Recruiting at 1 site in Egypt. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by Misr University for Science and Technology · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started May 2026; still recruiting 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
52
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

This study aims to assess the agreement between new computer software using dental photographs, digital spectrophotometer and the visual technique, in achieving accurate resin composite shade matching.

Read the detailed description
  • Custom composite resin shade tabs are fabricated and catalogued to serve as reference standards during shade matching.
  • Teeth are professionally cleaned on dental chair using a nylon prophylaxis brush with polishing paste to ensure complete removal of extrinsic stains and to reveal the native tooth color.
  • Participants will be seated on an adjustable chair in an upright posture, with the head oriented perpendicular to the floor and be stabilized by a headrest. The chair will be positioned against a matte white wall adjacent to a clear window to standardize a neutral background and exploit consistent daylight illumination.
  • Patients will be instructed to maintain an upright head posture with the interpupillary line parallel to the floor. All measurements will be performed under daylight, while extraneous light sources and environmental interferences to be minimized.

    • Computer-Assisted Software A standardized Computer-assisted photographic shade-matching workflow will be employed using a novel photo-analysis software that first receives the photos and balances each photo to suppress unrealistic colors using a standard gray reference card (WhiBal; Michael Tapes Design), with nominal colorimetric targets of L* =75, a* = 0, b* = 0, will be included in every photograph within the plane of the teeth.

The Photo is firstly captured with a Nikon D3400 DSLR crop-frame camera (Nikon Corp) mounted on a stable tripod to avoid movements during capturing the photo and set the proper angulation and parallelism. All camera parameters will be standardized.

The program establishes a pixel-to-metric conversion scale (cm) from known distances and overlays orthogonal reference axes to fix landmark orientation and reproducible measurement geometry. Using these guides, tooth height and width are annotated, and the region of interest is consistently defined at the central area of the middle third of the labial crown of either the tooth or shade tabs.

Candidate shades are then quantitatively compared to the region of interest by computing CIEDE2000 color-difference values (ΔE₀₀), which incorporate corrections for lightness, chroma, and hue; the final selected shade is the one yielding the smallest ΔE₀₀.

Where: ΔL', ΔC', ΔH' are the lightness, chroma, and hue differences in the CIEDE2000 framework; SL, SC, SH are weighting functions; kL, kC, kH are parametric factors (set to 1 unless otherwise justified); and RT is the rotation term accounting for interaction between chroma and hue differences.

  • Spectrophotometer assessment A pre-calibrated spectrophotometer (per manufacturer guidelines) independently measures tooth and shade-tab color. Measurements are reported as CIE L*, a*, b* values. For each tooth-tab combination, the CIEDE2000 color difference (ΔE00) is calculated; the tab yielding the minimal ΔE00 is accepted as the selected shade. 9
  • Visual Shade Matching Under the same conditions (lighting and patient positioning), experienced assessors independently determine the matching shade.

Agreement between their own assessments and between the other assessors' assessments, as well as the extent of their discrepancies, is quantified using kappa test.

02

Conditions studied

  • Shade Matching

Keywords

  • diagnostic accuracy
  • spectrophotometer
  • Computer assisted software
  • visual assessment
03

In context

Lead sponsor

Misr University for Science and Technology is the lead sponsor of 38 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age: 18-45 years.
  • Sex: Male or female.
  • General: Cooperative individuals who agree to participate and comply with study visits (written to be obtained as applicable).
  • Dentition: Presence of sound maxillary incisors that will meet the tooth-level criteria.

Exclusion criteria

Exclusion Criteria:

  • Poor oral hygiene.
  • Severe systemic/medical complications that may contraindicate elective dental care.
  • Pregnancy.
  • Heavy smokers.
  • Xerostomia.
  • Temporomandibular joint disorders.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
52 participants (estimated)

Study arms

  • Active comparator
    Digital Spectrophotometer

    A pre-calibrated spectrophotometer (per manufacturer guidelines) independently measures tooth and shade-tab color. Measurements are reported as CIE L\*, a\*, b\* values. For each tooth-tab combination, the CIEDE2000 color difference (ΔE00) is calculated; the tab yielding the minimal ΔE00 is accepted as the selected shade.

    Device: Computer-Assisted Software

  • Active comparator
    Visual Shade Matching

    Under the same conditions (lighting and patient positioning), experienced assessors independently determine the matching shade.

    Device: Computer-Assisted Software

Interventions

  • DeviceComputer-Assisted Software

    A standardized Computer-assisted photographic shade-matching workflow will be employed using a novel photo-analysis software that first receives the photos and balances each photo to suppress unrealistic colors using a standard gray reference card (WhiBal; Michael Tapes Design), with nominal colorimetric targets of L\* =75, a\* = 0, b\* = 0, will be included in every photograph within the plane of the teeth. The Photo is firstly captured with a Nikon D3400 DSLR crop-frame camera (Nikon Corp) mounted on a stable tripod to avoid movements during capturing the photo and set the proper angulation and parallelism. All camera parameters will be standardized. The program establishes a pixel-to-metric conversion scale (cm) from known distances and overlays orthogonal reference axes to fix landmark orientation and reproducible measurement geometry. Using these guides, tooth height and width are annotated, and the region of interest is consistently defined at the central area of the middle third.

06

What researchers measure

Primary outcomes

  1. Accuracy of computer software, digital Spectrophotometer and visual method in shade matching using resin composite tabs.

    • The outcome evaluates agreement of the computer software in comparison to spectrophotometer and traditional visual method.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Misr university for science and technology
    Sixth of October, Giza Governorate 12566, Egypt
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — will be shared with supervisors

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07707323
Lead sponsor
Misr University for Science and Technology
Responsible party
Ahmed Mohamed Saleh Ali Farrag (resident doctor, Misr University for Science and Technology) — Principal investigator
First posted
Jul 16, 2026
Start date
May 1, 2026
Primary completion
Sep 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Jul 16, 2026

Study contacts

Ahmed Saleh Ali ASA Resident doctor, Bachelor degree
Contact
ahmed.msaleh@must.edu.eg
+201147965014
Esraa Esmeail Hussien EEH lecturer, phd holder
Contact
dr.esraaism@gmail.com
+201111103836

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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