Discoloration, ToothNCT04817579
Dental Photography and Numeric Shade Quantification as a Substitute to Conventional and Instrumental Shade Matching Techniques in the Esthetic Zone
A study testing Digital photography combined with eLABor_aid shade analyzing software, Spectrophotometer and Conventional visual shade matching in people with Discoloration, Tooth and Chip Tooth, run by Cairo University at 1 site in Egypt.
Trial summary
Visual shade matching is the most common method, in which a color standard from a commercially available dental shade guide is compared to and matched with the target tooth. However, several factors can contribute to perception errors including: different lighting variables, multiple shade systems available in the… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Discoloration, Tooth, Chip Tooth, Non Vital Teeth
- What is being tested?
- Digital photography combined with eLABor_aid shade analyzing software, Spectrophotometer and Conventional visual shade matching
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2024to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age range of the patients from 20-50 years old; able to read and sign the informed consent document.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration (e.g. moderate discoloration, coronal fracture where partial coverage would lack retention, mal-posed or malformed teeth, esthetics enhancement of previously placed crown) where the contralateral/adjacent tooth is present.
- Patients with root canal treated teeth requiring full coverage restorations even if they need fiber post and core fabrication first.
Who cannot join
- Patients with poor oral hygiene and motivation.
- Patients with teeth with increased incisal translucency.
- Patients with severe discolored teeth.
- Patients with smoking habits.
- Patients with excessive consumption of coffee or tea.
- Pregnant women to avoid any complication that may occur in dental office due to pregnancy or due to injected anesthetic solution.
- Patients with psychiatric problems or unrealistic expectation (patient that has phobia from dental treatments or needle injection).
- Patients suffer from para-functional habits.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry, Cairo University
Cairo, 11555
Reham El basty, Ass. Prof.
About this study
Official title: Dental Photography and Numeric Shade Quantification as a Substitute to Conventional and Instrumental Shade Matching Techniques in the Esthetic Zone: A Controlled Clinical Trial
Visual shade matching is the most common method, in which a color standard from a commercially available dental shade guide is compared to and matched with the target tooth. However, several factors can contribute to perception errors including: different lighting variables, multiple shade systems available in the market with lack of standardization in color systems and corresponding porcelain systems, individual human variables in color perception and lack of understanding of color science.
Therefore, in order to eliminate the uncontrolled variables during the color matching process, instrumental methods have been developed. Spectrophotometric measurement methods employing computer calculations, based on color science and theories, allow quantitative evaluation which is objective and appears to be more accurate. However, extremely high costs, relatively low performance with respect to agreements of the computer-aided devices, and edge loss error make it less acceptable.
Read more
One of the most powerful tools in communicating with both patients and dental ceramists is digital photography. Hence, this study is designed to explore the possibilities of a novel approach to shade management (eLABor_aid) utilizing a photocolorimetric (PCM) method and subsequent shade formulation without the use of stock shade guides in comparison to well-known visual and instrumental methods.
The aim of the study is to evaluate the accuracy of digital photography combined with shade analyzing software (eLAB) in optimizing shade matching when compared to conventional and instrumental methods of shade selection.
A Null Hypothesis is suggested where no significant difference regarding shade selection between eLAB protocol, conventional and instrumental methods will be found.
- Conditions
- Discoloration, Tooth, Chip Tooth, Non Vital Teeth, Trauma Dental
- Being tested
- Digital photography combined with eLABor_aid shade analyzing software, Spectrophotometer, Conventional visual shade matching
- Medical subject headings
- Tooth Discoloration, Tooth Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital photography combined with eLABor_aid shade analyzing softwareDevice
Also called eLAB protocol
ELABor_aid is a new approach to objective shade communication and shade reproduction in dentistry, based on numeric quantification obtained from standardized RGB (red-green-blue) images, and the formulation of a patient personal shade recipe using trichromatic subtractive color mixing laws, thus abandoning the use of visual assessment and shade guides entirely. This approach is currently enjoying increasing popularity for its ease of use, reliability as well as for its practically oriented features like its imaging ability or the digital try-in.
SpectrophotometerDevice
Also called Vita Easy-shade
Spectrophotometric measurement methods employing computer calculations, based on color science and theories, allow quantitative evaluation which is objective and appears to be more accurate.
Conventional visual shade matchingDevice
Also called Ivoclar classic shade guide
Visual shade matching is the most common method, in which a color standard from a commercially available dental shade guide is compared to and matched with the target tooth.
| Study group | Role | What they receive |
|---|---|---|
| Conventional visual shade matching | Active comparator | Patients requiring single crown in the esthetic zone treated with Conventional visual shade matching (Ivoclar Classic shade guide) Receives: Device: Conventional visual shade matching |
| Spectrophotometer | Experimental | Patients requiring single crown in the esthetic zone treated with Spectrophotometer (Vita Easy Shade) Receives: Device: Spectrophotometer |
| Digital photography combined with eLABor_aid shade analyzing software. | Experimental | Patients requiring single crown in the esthetic zone treated with Digital photography combined with eLABor_aid shade analyzing software. Receives: Device: Digital photography combined with eLABor_aid shade analyzing software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Color difference (Delta E) calculated using calibrated images on photoshop software
Photoshop combined with dental photography using Delta E formula. Standardized images will be taken using a standardized protocol and a grey card to calibrate the produced images to ensure standard exposure in all photos. Delta E will be calculated using photoshop software.
Delta E (ΔE) = [(L1 - L2)² + (a1 - a2)² + (b1 - b2)²]1/2
Measured: Immediately after crowns try-in. The crown with the best result will be instantly cemented.
Secondary outcomes (1)
Shade match using modified USPHS criteria
Alpha (Excellent): ideal. Bravo (Acceptable): less than ideal but no modifications required Charlie (Acceptable but modifications needed): staining or other shade modifications required.
Delta (Unacceptable): remake.
Measured: Immediately after Try-in stage. Each crown will be seated in the patient's mouth and a score will be given by a blinded assessor. The crown with the best shade match will be finally cemented.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study startJul 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discoloration, ToothStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- Each patient will try in three crowns with different methods for shade matching.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Ahmed Farid Zaki Shehab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04817579
- Sponsor's protocol ID
- 39920
- Status last verified
- Jun 2024
- First submitted
- 13 Mar 2021
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dental Photography and Numeric Shade Quantification as a Substitute to Conventional and Instrumental Shade Matching Techniques in the Esthetic Zone: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04817579
- Acronym / sponsor ID
- 39920
- Conditions
- Discoloration, Tooth, Chip Tooth, Non Vital Teeth, Trauma Dental
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 26 Mar 2021 (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.
Visual shade matching is the most common method, in which a color standard from a commercially available dental shade guide is compared to and matched with the target tooth. However, several factors can contribute to perception errors including: different lighting variables, multiple shade systems available in the market with lack of standardization in color systems and corresponding porcelain systems, individual human variables in color perception and lack of understanding of color science.
Therefore, in order to eliminate the uncontrolled variables during the color matching process, instrumental methods have been developed. Spectrophotometric measurement methods employing computer calculations, based on color science and theories, allow quantitative evaluation which is objective and appears to be more accurate. However, extremely high costs, relatively low performance with respect to agreements of the computer-aided devices, and edge loss error make it less acceptable.
One of the most powerful tools in communicating with both patients and dental ceramists is digital photography. Hence, this study is designed to explore the possibilities of a novel approach to shade management (eLABor_aid) utilizing a photocolorimetric (PCM) method and subsequent shade formulation without the use of stock shade guides in comparison to well-known visual and instrumental methods.
The aim of the study is to evaluate the accuracy of digital photography combined with shade analyzing software (eLAB) in optimizing shade matching when compared to conventional and instrumental methods of shade selection.
A Null Hypothesis is suggested where no significant difference regarding shade selection between eLAB protocol, conventional and instrumental methods will be found.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Each patient will try in three crowns with different methods for shade matching.
| Arm | Type | Receives |
|---|---|---|
| Conventional visual shade matching | Active comparator | Device: Conventional visual shade matchingPatients requiring single crown in the esthetic zone treated with Conventional visual shade matching (Ivoclar Classic shade guide) |
| Spectrophotometer | Experimental | Device: SpectrophotometerPatients requiring single crown in the esthetic zone treated with Spectrophotometer (Vita Easy Shade) |
| Digital photography combined with eLABor_aid shade analyzing software. | Experimental | Device: Digital photography combined with eLABor_aid shade analyzing softwarePatients requiring single crown in the esthetic zone treated with Digital photography combined with eLABor_aid shade analyzing software. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age range of the patients from 20-50 years old; able to read and sign the informed consent document.
- Patients able physically and psychologically to tolerate conventional restorative procedures.
- Patients with no active periodontal or pulpal diseases, having teeth with good restorations.
- Patients with teeth problems indicated for full coverage restoration (e.g. moderate discoloration, coronal fracture where partial coverage would lack retention, mal-posed or malformed teeth, esthetics enhancement of previously placed crown) where the contralateral/adjacent tooth is present.
- Patients with root canal treated teeth requiring full coverage restorations even if they need fiber post and core fabrication first.
Key exclusion criteria (8 listed)
- Patients with poor oral hygiene and motivation.
- Patients with teeth with increased incisal translucency.
- Patients with severe discolored teeth.
- Patients with smoking habits.
- Patients with excessive consumption of coffee or tea.
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 |
|---|---|---|
| Digital photography combined with eLABor_aid shade analyzing softwareAlso: eLAB protocolELABor_aid is a new approach to objective shade communication and shade reproduction in dentistry, based on numeric quantification obtained from standardized RGB (red-green-blue) images, and the formulation of a patient personal shade recipe using trichromatic subtractive color mixing laws, thus abandoning the use of visual assessment and shade guides entirely. This approach is currently enjoying increasing popularity for its ease of use, reliability as well as for its practically oriented features like its imaging ability or the digital try-in. | Device | Digital photography combined with eLABor_aid shade analyzing software. |
| SpectrophotometerAlso: Vita Easy-shadeSpectrophotometric measurement methods employing computer calculations, based on color science and theories, allow quantitative evaluation which is objective and appears to be more accurate. | Device | Spectrophotometer |
| Conventional visual shade matchingAlso: Ivoclar classic shade guideVisual shade matching is the most common method, in which a color standard from a commercially available dental shade guide is compared to and matched with the target tooth. | Device | Conventional visual shade matching |
Primary outcome
Color difference (Delta E) calculated using calibrated images on photoshop software
Time frame: Immediately after crowns try-in. The crown with the best result will be instantly cemented.
Photoshop combined with dental photography using Delta E formula. Standardized images will be taken using a standardized protocol and a grey card to calibrate the produced images to ensure standard exposure in all photos. Delta E will be calculated using photoshop software. Delta E (ΔE) = [(L1 - L2)² + (a1 - a2)² + (b1 - b2)²]1/2
1 secondary outcome
Shade match using modified USPHS criteria
Time frame: Immediately after Try-in stage. Each crown will be seated in the patient's mouth and a score will be given by a blinded assessor. The crown with the best shade match will be finally cemented.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital photography combined with eLABor_aid shade analyzing software, Spectrophotometer and Conventional visual shade matching in people with Discoloration, Tooth and Chip Tooth, run by Cairo University 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada F Shehab (+201223402909, nada.farid@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Color difference (Delta E) calculated using calibrated images on photoshop software (time frame: Immediately after crowns try-in. The crown with the best result will be instantly cemented.). 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 25 Jun 2024.