Accuracy of Dental Shade Selection in the Aesthetic ZoneNCT03229707
Impact Of Digital Photography & Conventional Method On The Accuracy Of Dental Shade Matching In The Esthetic Zone
A study testing Digital photography using software Photoshop and Vita 3D master shade guide in people with Accuracy of Dental Shade Selection in the Aesthetic Zone, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study: Is to evaluate the accuracy of digital photography in optimizing shade matching when compared to conventional method of shade selection. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Accuracy of Dental Shade Selection in the Aesthetic Zone
- What is being tested?
- Digital photography using software Photoshop and Vita 3D master shade guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2018to 1 Aug 2019
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients between 18-70 years old, able to read and sign the informed consent document.
- Patients requiring restorations in the esthetic zone.
- Patients don't have active periodontal or pulpal diseases
- Patients willing to return for follow-up examination and evaluation.
Who cannot join
- Patients in the growth stage.
- Patients with poor oral hygiene and lack of motivation.
- Psychiatric problems or unrealistic expectations.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact Of Digital Photography & Conventional Method On The Accuracy Of Shade Matching In The Esthetic Zone
The aim of this study:
Is to evaluate the accuracy of digital photography in optimizing shade matching when compared to conventional method of shade selection.
Read the detailed description
Randomized control trial, 2 groups will be included. Group 1: Color matching using Vita 3D master, using modified (USPHS) criteria Group 2: Color matching using digital photography using (Photoshop adopt) the assessment will be through a questionnaire for the patient satisfaction outcome using Visual analogue scale
- Being tested
- Digital photography using software Photoshop, Vita 3D master shade guide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital photography using software PhotoshopDevice
When taking the image, a gray card is used for subsequent exposure calibration in Adobe Camera Raw (which is packaged with Photoshop).
- Images are then opened into Photoshop.
- The "INFO" panel must be open.
- Click on the small eyedropper in the Info panel window and click on ''Lab Color".
- Place the mouse over the center of the tooth to be measured for L value.
- Click on the "HSB Color" option, which stands for hue, saturation, and brightness.
Vita 3D master shade guideDevice
Also called Conventional shade matching
Alpha (A)Perfectly matched Beta (B)Not perfectly matched Charlie (C)unacceptable Determent by 10 observers
| Study group | Role | What they receive |
|---|---|---|
| group 1 Color matching using Vita 3D master | Active comparator | Outcome Name: Color Matching measured by :
Modified (USPHS) criteria Receives: Device: Vita 3D master shade guide |
| group 2 Color matching using digital photography | Experimental | Outcome Name: Color Matching measured by Digital Photography using (Photoshop)
Software:
* 0 to 1: no difference in perception
* 1 to 2: only perceptible to a trained observer
* 2 to 3.5: perceptible difference
* 3.5 to 5: marked difference Receives: Device: Digital photography using software Photoshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction
Visual analogue scale
Measured: 1 year
Secondary outcomes (1)
Color Matching
Digital Photography using (Photoshop)/using Vita 3D master Modified (USPHS) criteria
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Jul 2018
- Primary completion31 Oct 2018
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accuracy of Dental Shade Selection in the Aesthetic ZoneStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rawan Ferroukhi, Cairo University
- Investigators
- Rawan Ferroukhi, Masters in FixedProsthodontics, Principal investigator, MSc Student of Fixed Prosthodontics, Division of Fixed Prosthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229707
- Sponsor's protocol ID
- CEBC-CU-2017-07-17
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2017
- Last updated
- 29 Jul 2021
- 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 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Of Digital Photography & Conventional Method On The Accuracy Of Shade Matching In The Esthetic Zone
- ClinicalTrials.gov ID
- NCT03229707
- Acronym / sponsor ID
- CEBC-CU-2017-07-17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 31 Oct 2018 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 25 Jul 2017 (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.
The aim of this study:
Is to evaluate the accuracy of digital photography in optimizing shade matching when compared to conventional method of shade selection.
Detailed description
Randomized control trial, 2 groups will be included. Group 1: Color matching using Vita 3D master, using modified (USPHS) criteria Group 2: Color matching using digital photography using (Photoshop adopt) the assessment will be through a questionnaire for the patient satisfaction outcome using Visual analogue scale
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 Color matching using Vita 3D master | Active comparator | Device: Vita 3D master shade guideOutcome Name: Color Matching measured by : Modified (USPHS) criteria |
| group 2 Color matching using digital photography | Experimental | Device: Digital photography using software PhotoshopOutcome Name: Color Matching measured by Digital Photography using (Photoshop) Software: * 0 to 1: no difference in perception * 1 to 2: only perceptible to a trained observer * 2 to 3.5: perceptible difference * 3.5 to 5: marked difference |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients between 18-70 years old, able to read and sign the informed consent document.
- Patients requiring restorations in the esthetic zone.
- Patients don't have active periodontal or pulpal diseases
- Patients willing to return for follow-up examination and evaluation.
Key exclusion criteria (3 listed)
- Patients in the growth stage.
- Patients with poor oral hygiene and lack of motivation.
- Psychiatric problems or unrealistic expectations.
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 using software PhotoshopWhen taking the image, a gray card is used for subsequent exposure calibration in Adobe Camera Raw (which is packaged with Photoshop). * Images are then opened into Photoshop. * The "INFO" panel must be open. * Click on the small eyedropper in the Info panel window and click on ''Lab Color". * Place the mouse over the center of the tooth to be measured for L value. * Click on the "HSB Color" option, which stands for hue, saturation, and brightness. | Device | group 2 Color matching using digital photography |
| Vita 3D master shade guideAlso: Conventional shade matchingAlpha (A)Perfectly matched Beta (B)Not perfectly matched Charlie (C)unacceptable Determent by 10 observers | Device | group 1 Color matching using Vita 3D master |
Primary outcome
Patient satisfaction
Time frame: 1 year
Visual analogue scale
1 secondary outcome
Color Matching
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Related InfoLink provided by the sponsor.
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.
Rawan Ferroukhi, Masters in FixedProsthodontics principal investigator
MSc Student of Fixed Prosthodontics, Division of Fixed Prosthodontics, Faculty of Dentistry, Cairo University, Cairo, Egypt
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 using software Photoshop and Vita 3D master shade guide in people with Accuracy of Dental Shade Selection in the Aesthetic Zone, 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jul 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction (time frame: 1 year). 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 29 Jul 2021.