Shade MatchingNCT07707323
Diagnostic Accuracy of Innovative Photo-Analysis Software in Resin Composite Shade Matching
A study testing Computer-Assisted Software in people with Shade Matching, run by Misr University for Science and Technology at 1 site in Egypt.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Shade Matching
- What is being tested?
- Computer-Assisted Software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2026to 1 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Poor oral hygiene.
- Severe systemic/medical complications that may contraindicate elective dental care.
- Pregnancy.
- Heavy smokers.
- Xerostomia.
- Temporomandibular joint disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Misr university for science and technology
Sixth of October, Giza Governorate, 12566
About this study
Official title: 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.
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.
- Conditions
- Shade Matching
- Being tested
- Computer-Assisted Software
- Keywords
- diagnostic accuracy, spectrophotometer, Computer assisted software, visual assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Assisted SoftwareDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital Spectrophotometer | Active comparator | 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. Receives: Device: Computer-Assisted Software |
| Visual Shade Matching | Active comparator | Under the same conditions (lighting and patient positioning), experienced assessors independently determine the matching shade. Receives: Device: Computer-Assisted Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 May 2026
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shade MatchingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- diagnostic accuracy study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohamed Saleh Ali Farrag, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07707323
- Sponsor's protocol ID
- 2026/0037
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: will be shared with supervisors
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Diagnostic Accuracy of Innovative Photo-Analysis Software and Digital Spectrophotometer Compared With Visual Technique in Resin Composite Shade Matching
- ClinicalTrials.gov ID
- NCT07707323
- Acronym / sponsor ID
- 2026/0037
- Conditions
- Shade Matching
- Keywords
- diagnostic accuracy, spectrophotometer, Computer assisted software, visual assessment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 16 Jul 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.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- diagnostic accuracy study
| Arm | Type | Receives |
|---|---|---|
| Digital Spectrophotometer | Active comparator | Device: Computer-Assisted SoftwareA 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. |
| Visual Shade Matching | Active comparator | Device: Computer-Assisted SoftwareUnder the same conditions (lighting and patient positioning), experienced assessors independently determine the matching shade. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- Poor oral hygiene.
- Severe systemic/medical complications that may contraindicate elective dental care.
- Pregnancy.
- Heavy smokers.
- Xerostomia.
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 |
|---|---|---|
| Computer-Assisted SoftwareA 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. | Device | Digital Spectrophotometer, Visual Shade Matching |
Primary outcome
Accuracy of computer software, digital Spectrophotometer and visual method in shade matching using resin composite tabs.
Time frame: Baseline
• The outcome evaluates agreement of the computer software in comparison to spectrophotometer and traditional visual method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: Yes. will be shared with supervisors
Related trials for Shade Matching
Not yet recruiting
Clinical Evaluation and Patient Satisfaction of Shade Matching Between Natural Teeth and Monolithic All-ceramic Crowns Fabricated From Two Materials
Natural Optical Properties
Active, not recruiting
Evaluation of Clinical Performance, Shade Matching, and Patient Satisfaction of Different Resin Composite Layering Techniques Using 3D Printed Cast
Tooth Fractures (Class IV), Composite Resins
Not yet recruitingObservational study
AI-Assisted Shade Selection Versus Digital Spectrophotometry in Determining Maxillary Anterior Tooth Color in a Group of Egyptian Patients at Cairo University, Faculty of Dentistry Hospital (Diagnostic Accuracy Study)
Shade Match, Shade Selection
RecruitingObservational study
Colour Match, Stability, and Patient's Satisfaction of Single-Shade Composites in Anterior Teeth
Tooth Injuries, Dental Restoration, Permanent
RecruitingObservational study
Colorimetric, Ultra-structural and Elemental Comparison of Dental Enamel Defects
Amelogenesis Imperfecta, Dental Fluoroses
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Assisted Software in people with Shade Matching, run by Misr University for Science and Technology at 1 site in Egypt.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Jul 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Saleh Ali ASA Resident doctor, Bachelor degree (+201147965014, ahmed.msaleh@must.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of computer software, digital Spectrophotometer and visual method in shade matching using resin composite tabs. (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 16 Jul 2026.