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

15. juli 2026 oppdatert av: Ahmed Mohamed Saleh Ali Farrag, Misr University for Science and Technology

In Vivo Diagnostic Accuracy of Innovative Photo-Analysis Software and Digital Spectrophotometer Compared With Visual Technique in Resin Composite Shade Matching

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

  • 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.

Studietype

Intervensjonell

Registrering (Antatt)

52

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

  • Navn: Esraa Esmeail Hussien EEH lecturer, phd holder
  • Telefonnummer: +201111103836
  • E-post: dr.esraaism@gmail.com

Studer Kontakt Backup

  • Navn: Ahmed Saleh Ali ASA Resident doctor, Bachelor degree
  • Telefonnummer: +201147965014
  • E-post: ahmed.msaleh@must.edu.eg

Studiesteder

    • Giza Governorate
      • Sixth of October, Giza Governorate, Egypt, 12566
        • Rekruttering
        • Misr University for Science and Technology

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

Inclusion Criteria:

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

Exclusion Criteria:

  • Poor oral hygiene.
  • Severe systemic/medical complications that may contraindicate elective dental care.
  • Pregnancy.
  • Heavy smokers.
  • Xerostomia.
  • Temporomandibular joint disorders.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: 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.

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.

Aktiv komparator: Visual Shade Matching
Under the same conditions (lighting and patient positioning), experienced assessors independently determine the matching shade.

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Accuracy of computer software, digital Spectrophotometer and visual method in shade matching using resin composite tabs.
Tidsramme: Baseline
• The outcome evaluates agreement of the computer software in comparison to spectrophotometer and traditional visual method.
Baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. mai 2026

Primær fullføring (Antatt)

1. september 2026

Studiet fullført (Antatt)

1. oktober 2026

Datoer for studieregistrering

Først innsendt

10. juli 2026

Først innsendt som oppfylte QC-kriteriene

15. juli 2026

Først lagt ut (Faktiske)

16. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

will be shared with supervisors

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • ANALYTIC_CODE
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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