Healthy ParticipantsNCT07108946
the Effect of Different Background Color and Skin Tone on the Accuracy of Auricular Scanning
A study testing Black background, White background and Participant own skin as a background in people with Healthy Participants, run by yasmine Elsherbeeny at 1 site in Egypt.
Trial summary
The goal of this study is to find the best miss and match background color around an ear when taking scans for it , the investigators will recruit participants of three different skin tone and will scan their ear three times; one scan without any background, second scan with black one and the third scan with white… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Black background, White background and Participant own skin as a background
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteEgypt
- Study dates
- 26 Jul 2025to 30 Dec 2025
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Three types of skin tones will be selected; type I, type III and type VI according to The Fitzpatrick Scale.
- Participants with intact ears.
- Participants not exposed to sun burns or tans.
Who cannot join
- 1- Uncooperative participants.
- 2-Participants without intact ears.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Skin Tone and Background Color on the Accuracy of Auricular Scanning: A Clinical Trial
The goal of this study is to find the best miss and match background color around an ear when taking scans for it , the investigators will recruit participants of three different skin tone and will scan their ear three times; one scan without any background, second scan with black one and the third scan with white background, then the investigators will take an actual physical impression of the participants ear and the investigators will obtain a cast which will be scanned also and its scan will be compared to the three scans taken with different backgrounds to find the best combination.
Read the detailed description
Manufacturing the Extraoral prosthesis is troublesome for the patient, the dental practitioner and the dental technician. When a person misses his ear congenitally or due to trauma, he wishes to have an accurate replacement for his ear with minimum steps and effort. Digital technology has been providing the dental field with the most helpful equipment in such cases. Owing to the innovation of intraoral scanners with its continuous refinement, this patient now can rest assured that he will have his auricular prosthesis with less number of visits and less effort. There are different environmental factors that can affect scanning accuracy such as patients skin tone and scanning background.This study aims to evaluate the different backgrounds and skin tones effect on the trueness of auricular scanning. Participants with different skin tones (black, white and intermediate) will be selected with intact ears, then conventional impression will be taken and stone cast will be obtained and scanned via an extraoral scanner, then intraoral scanner will be used to scan the auricle three times, first with a black background, second with white background, third without background. Trueness of the scans will be evaluated by metrological software. Data will be collected, tabulated, and statistically analyzed.
- Conditions
- Healthy Participants
- Being tested
- Black background, White background, Participant own skin as a background
- Keywords
- Auricular scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black backgroundOther
Changing the background color during scanning to evaluate its effect on scan quality .
White backgroundOther
Changing the background color during scanning to evaluate its effect on scan quality .
Participant own skin as a backgroundOther
Changing the background color during scanning to evaluate its effect on scan quality .
| Study group | Role | What they receive |
|---|---|---|
| Type I Fitzpatrick Scale skin tone participant | Experimental | participants of this skin tone will have their ears scanned across three different backgrounds. Receives: Other: Black background; Other: White background; Other: Participant own skin as a background |
| Type III Fitzpatrick Scale skin tone participant | Experimental | participants of this skin tone will have their ears scanned across three different backgrounds. Receives: Other: Black background; Other: White background; Other: Participant own skin as a background |
| Type IV Fitzpatrick Scale skin tone participant | Experimental | participants of this skin tone will have their ears scanned across three different backgrounds. Receives: Other: Black background; Other: White background; Other: Participant own skin as a background |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of different backgrounds and skin tones on trueness of auricular scans via intraoral scanner.
The resultant standard tessellation files (STL) of every scan done via the intraoral scanner will be compared to the STL of the scan done via the extraoral scanner of the same participant by a metrological software to evaluate trueness.
Measured: The study is expected to take place over a 6-week period. Each participant will be scheduled for one session lasting approximately one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start26 Jul 2025
- Primary completion30 Sep 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- yasmine Elsherbeeny
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, yasmine Elsherbeeny, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07108946
- Sponsor's protocol ID
- FDASU-Rec IR032512
- Status last verified
- Oct 2026
- First submitted
- 29 Jul 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Skin Tone and Background Color on the Accuracy of Auricular Scanning: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07108946
- Acronym / sponsor ID
- FDASU-Rec IR032512
- Conditions
- Healthy Participants
- Keywords
- Auricular scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- yasmine ElsherbeenyUniversity, hospital or other
- Study start
- 26 Jul 2025 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 7 Aug 2025 (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 goal of this study is to find the best miss and match background color around an ear when taking scans for it , the investigators will recruit participants of three different skin tone and will scan their ear three times; one scan without any background, second scan with black one and the third scan with white background, then the investigators will take an actual physical impression of the participants ear and the investigators will obtain a cast which will be scanned also and its scan will be compared to the three scans taken with different backgrounds to find the best combination.
Detailed description
Manufacturing the Extraoral prosthesis is troublesome for the patient, the dental practitioner and the dental technician. When a person misses his ear congenitally or due to trauma, he wishes to have an accurate replacement for his ear with minimum steps and effort. Digital technology has been providing the dental field with the most helpful equipment in such cases. Owing to the innovation of intraoral scanners with its continuous refinement, this patient now can rest assured that he will have his auricular prosthesis with less number of visits and less effort. There are different environmental factors that can affect scanning accuracy such as patients skin tone and scanning background.This study aims to evaluate the different backgrounds and skin tones effect on the trueness of auricular scanning. Participants with different skin tones (black, white and intermediate) will be selected with intact ears, then conventional impression will be taken and stone cast will be obtained and scanned via an extraoral scanner, then intraoral scanner will be used to scan the auricle three times, first with a black background, second with white background, third without background. Trueness of the scans will be evaluated by metrological software. Data will be collected, tabulated, and statistically analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type I Fitzpatrick Scale skin tone participant | Experimental | Other: Black background, Other: White background, Other: Participant own skin as a backgroundparticipants of this skin tone will have their ears scanned across three different backgrounds. |
| Type III Fitzpatrick Scale skin tone participant | Experimental | Other: Black background, Other: White background, Other: Participant own skin as a backgroundparticipants of this skin tone will have their ears scanned across three different backgrounds. |
| Type IV Fitzpatrick Scale skin tone participant | Experimental | Other: Black background, Other: White background, Other: Participant own skin as a backgroundparticipants of this skin tone will have their ears scanned across three different backgrounds. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Three types of skin tones will be selected; type I, type III and type VI according to The Fitzpatrick Scale.
- Participants with intact ears.
- Participants not exposed to sun burns or tans.
Key exclusion criteria (2 listed)
- 1- Uncooperative participants.
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 |
|---|---|---|
| Black backgroundChanging the background color during scanning to evaluate its effect on scan quality . | Other | Type I Fitzpatrick Scale skin tone participant, Type III Fitzpatrick Scale skin tone participant, Type IV Fitzpatrick Scale skin tone participant |
| White backgroundChanging the background color during scanning to evaluate its effect on scan quality . | Other | Type I Fitzpatrick Scale skin tone participant, Type III Fitzpatrick Scale skin tone participant, Type IV Fitzpatrick Scale skin tone participant |
| Participant own skin as a backgroundChanging the background color during scanning to evaluate its effect on scan quality . | Other | Type I Fitzpatrick Scale skin tone participant, Type III Fitzpatrick Scale skin tone participant, Type IV Fitzpatrick Scale skin tone participant |
Primary outcome
Evaluation of the effect of different backgrounds and skin tones on trueness of auricular scans via intraoral scanner.
Time frame: The study is expected to take place over a 6-week period. Each participant will be scheduled for one session lasting approximately one hour.
The resultant standard tessellation files (STL) of every scan done via the intraoral scanner will be compared to the STL of the scan done via the extraoral scanner of the same participant by a metrological software to evaluate trueness.
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 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black background, White background and Participant own skin as a background in people with Healthy Participants, run by yasmine Elsherbeeny 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 3 inclusion and 2 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 27 Oct 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?
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?
Evaluation of the effect of different backgrounds and skin tones on trueness of auricular scans via intraoral scanner. (time frame: The study is expected to take place over a 6-week period. Each participant will be scheduled for one session lasting approximately one hour.). 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 27 Oct 2026.