Facial NeoplasmsNCT07557212
A Comparison of Accuracy Between Different Facial Scanning Techniques
A study testing portable scanning, stationery scanning and mobile app scanning in people with Facial Neoplasms, run by Ain Shams University.
Trial summary
Conventional alginate impressions are still a burden to both the patient and the operator especially in extraoral maxillofacial rehabilitations cases. Nowadays face scanners are becoming more popular with their increased accuracy in taking facial scans, facilitating the digital workflow. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Facial Neoplasms
- What is being tested?
- portable scanning, stationery scanning and mobile app scanning
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 2 May 2026to 1 Nov 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Those who completed growth
Who cannot join
- Men with beards.
- Those with maxillofacial deformity
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Comparative Study of Trueness and Precision Between Different Facial Scanning Techniques
Conventional alginate impressions are still a burden to both the patient and the operator especially in extraoral maxillofacial rehabilitations cases. Nowadays face scanners are becoming more popular with their increased accuracy in taking facial scans, facilitating the digital workflow.
This study will be done to investigate the accuracy of three different face scanning techniques; stationary, handheld and mobile application techniques.
A number of sixty volunteers will be recruited. Conventional facial impressions will be made for each participant and the resulting casts will be desktop scanned to act as the control group. Three face scanning techniques will be used for each participant; stationary (Ray face scanner), handheld (Shining 3d face scanner) and mobile phone applications (Heges; Maerk Simonik). The STL files will be compared to that of the control group for comparison of accuracy in the terms of Trueness and Precision.
Read the detailed description
- Study Setting: The study will be conducted in the Oral and Maxillofacial Prosthodontics Department.
- Sample Size Calculation: Sixty participants will be selected to share in this study from the outpatient clinic of Prosthodontics Department, Faculty of Dentistry, Ain-Shams University. G power program (3. 1) was used for calculations of sample size. Statistical calculator was based on 95% confidence interval and power of the study 80% with α error 5%.
According to a previous study done by Nuytens et al. " Trueness and precision of a handheld, a desktop and a mobile 3D face scanning system: An in vitro study"
- Eligibility criteria: Inclusion Criteria Those who completed growth. Exclusion Criteria
1- Men with beards. 2- Those with maxillofacial deformity Justification for Exclusions (Those will interfere with the scan)
- Randomization and allocation concealment technique: Randomized Controlled Trial (RCT) Randomization will be guided by a computer-generated list. The groups will be placed in numbered closed opaque sealed envelopes according to the computer-generated list of random numbers and an envelope will be allocated to each patient. Double blinding will be done by one of the postgraduate students who will be the only one to know the key so that the authors and the patients won't know in which group the patient will be. Afterwards, the authors will be informed by the randomization to be tabulated.
- Details of the interventions, testing and follow up The total of 60 scans will be analyzed using (Geomagic metrology software). Fourteen inter-landmark distances will be digitally measured to assess three facial regions-upper, middle, and lower face-and categorized into vertical and horizontal dimensions. This boundary will be replicated on each of the experimental scans using a best-fit alignment technique. For each distance, trueness will be calculated as the mean absolute deviation from the reference measurements across all scans for each modality. Precision will be assessed by computing the standard deviation of the repeated measurements for each distance.
The patients will be divided into three groups; group (I), group (II) and group (III).
In all groups; 14 landmarks will be taken as reference points at the following positions: glabella (g), right exocanthion (exR), left exocanthion (exL), right endocanthion (enR), left endocanthion (enL), pronasale (prn), right alare (alR), left alare (alL), subnasale (sn), labiale superius (ls), labiale inferius (li), right chelion (chR), left chelion (chL), pogonion (pg).
In all groups, A reference scan will be acquired in the form of a cast driven through alginate impression, then the cast will be scanned by desktop scanner. Scanning will be exported as a standard tessellation language (STL).
3D face scanning systems: Three scanning modalities will be tested. All scans will be conducted by the same operator in identical lighting, temperature (24°C), pressure (760 mmHg), and humidity (45%) conditions. In all scans, the head position will be standardized by a head-chin rest.
Group I: Handheld scanner (Metismile; Shining 3D, China):
Uses an infrared structured light system with a VCSEL projector. It contains three 1.3 MP cameras for data acquisition and one 5 MP texture camera. A series of scans will be taken each session took about 35 seconds. Scans will be captured according to manufacturer calibration protocols, processed in HD mode, and exported as PLY files.
Group II: Desktop scanner (RAYFace v2.0; Ray Co., Korea):
Employs white and blue structured light technology combined with depth and infrared sensors. The scanning duration will be approximately 0.5 seconds per scan. The scan will be taken following manufacturer guidelines, and scans will be exported in PLY format after HD processing Group III: Mobile face scanning application (Heges; Marek Simonik) on a smart device (iPad Pro X, Apple Inc., Cupertino, CA) It has a True Depth camera utilizing VCSEL technology, projecting 30,000 IR dots for depth mapping at a working distance of 300-450 mm. A tablet stand will be used for stability.
- An experienced single calibrated operator is going to do all the scans for each technique.
- Blinding techniques Single blinding will be done for the outcome assessor.
Method of evaluation:
A total of Sixty scans will be analyzed using (Geomagic metrology software). Inter-landmark distances will be digitally measured to assess three facial regions-upper, middle, and lower face-and categorized into vertical and horizontal dimensions. This boundary will be replicated on each of the experimental scans using a best-fit alignment technique. For each distance, trueness will be calculated as the mean absolute deviation from the reference measurements across all scans for each modality. Precision will be assessed by computing the standard deviation of the repeated measurements for each distance.
IX. Statistical Analysis The data will be collected, arranged, and tabulated to be statistically analyzed.
- Conditions
- Facial Neoplasms
- Being tested
- portable scanning, stationery scanning, mobile app scanning
- Keywords
- face scanning
- Medical subject headings
- Facial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
portable scanningProcedure or surgery
face scanning will be made using a portable face scanner
stationery scanningProcedure or surgery
ace scanning will be made using a stationery face scanner
mobile app scanningProcedure or surgery
ace scanning will be made using a mobile face scanning app
| Study group | Role | What they receive |
|---|---|---|
| Handheld scanner | Experimental | A series of scans will be taken each session took about 35 seconds. Scans will be captured according to manufacturer calibration protocols, processed in HD mode, and exported as PLY files and superimposed on the reference scan. Receives: Procedure: portable scanning |
| stationery scanner | Experimental | The scanning duration will be approximately 0.5 seconds per scan. The scan will be taken following manufacturer guidelines, and scans will be exported in PLY format after HD processing and superimposed on the reference scan. Receives: Procedure: stationery scanning |
| Mobile face scanning application | Experimental | A tablet stand will be used for stability. Receives: Procedure: mobile app scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy measurement
Inter-landmark distances will be digitally measured to assess three facial regions-upper, middle, and lower face-and categorized into vertical and horizontal dimensions. This boundary will be replicated on each of the experimental scans using a best-fit alignment technique. For each distance, trueness will be calculated as the mean absolute deviation from the reference measurements across all scans for each modality. Precision will be assessed by computing the standard deviation of the repeated measurements for each distance.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start2 May 2026 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial NeoplasmsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be divided into three groups;(I),(II) and(III).In all groups; 14 landmarks will be taken as reference points. A reference scan will be acquired in the form of a cast driven through alginate impression, then the cast will be scanned by desktop scanner. Scanning will be exported as a standard tessellation language (STL).Three scanning modalities will be tested. All scans will be conducted by the same operator in identical lighting, temperature (24°C), pressure (760 mmHg), and humidity (45%) conditions. In all scans, the head position will be standardized by a head-chin rest. Group I: Handheld scanner (Metismile; Shining 3D, China).Group II: Desktop scanner (RAYFace v2.0; Ray Co., Korea).Group III: Mobile face scanning (Heges; Marek Simonik) (iPad Pro X, Apple Inc., Cupertino, CA) .A tablet stand will be used for stability. An experienced single calibrated operator is going to do all the scans for each technique.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mostafa Abdelfatah, Ain Shams University
- Investigators
- Ahmed Mohamed, MD, Principal investigator, Faculty of dentistry, ain shams university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557212
- Sponsor's protocol ID
- FDASU-REC IR/M 122503
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be provided once being available upon reasonable request from the principal investigator
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Trueness and Precision Between Different Facial Scanning Techniques
- ClinicalTrials.gov ID
- NCT07557212
- Acronym / sponsor ID
- FDASU-REC IR/M 122503
- Conditions
- Facial Neoplasms
- Keywords
- face scanning
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 2 May 2026 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 29 Apr 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.
Conventional alginate impressions are still a burden to both the patient and the operator especially in extraoral maxillofacial rehabilitations cases. Nowadays face scanners are becoming more popular with their increased accuracy in taking facial scans, facilitating the digital workflow.
This study will be done to investigate the accuracy of three different face scanning techniques; stationary, handheld and mobile application techniques.
A number of sixty volunteers will be recruited. Conventional facial impressions will be made for each participant and the resulting casts will be desktop scanned to act as the control group. Three face scanning techniques will be used for each participant; stationary (Ray face scanner), handheld (Shining 3d face scanner) and mobile phone applications (Heges; Maerk Simonik). The STL files will be compared to that of the control group for comparison of accuracy in the terms of Trueness and Precision.
Detailed description
- Study Setting: The study will be conducted in the Oral and Maxillofacial Prosthodontics Department.
- Sample Size Calculation: Sixty participants will be selected to share in this study from the outpatient clinic of Prosthodontics Department, Faculty of Dentistry, Ain-Shams University. G power program (3. 1) was used for calculations of sample size. Statistical calculator was based on 95% confidence interval and power of the study 80% with α error 5%.
According to a previous study done by Nuytens et al. " Trueness and precision of a handheld, a desktop and a mobile 3D face scanning system: An in vitro study"
- Eligibility criteria: Inclusion Criteria Those who completed growth. Exclusion Criteria
1- Men with beards. 2- Those with maxillofacial deformity Justification for Exclusions (Those will interfere with the scan)
- Randomization and allocation concealment technique: Randomized Controlled Trial (RCT) Randomization will be guided by a computer-generated list. The groups will be placed in numbered closed opaque sealed envelopes according to the computer-generated list of random numbers and an envelope will be allocated to each patient. Double blinding will be done by one of the postgraduate students who will be the only one to know the key so that the authors and the patients won't know in which group the patient will be. Afterwards, the authors will be informed by the randomization to be tabulated.
- Details of the interventions, testing and follow up The total of 60 scans will be analyzed using (Geomagic metrology software). Fourteen inter-landmark distances will be digitally measured to assess three facial regions-upper, middle, and lower face-and categorized into vertical and horizontal dimensions. This boundary will be replicated on each of the experimental scans using a best-fit alignment technique. For each distance, trueness will be calculated as the mean absolute deviation from the reference measurements across all scans for each modality. Precision will be assessed by computing the standard deviation of the repeated measurements for each distance.
The patients will be divided into three groups; group (I), group (II) and group (III).
In all groups; 14 landmarks will be taken as reference points at the following positions: glabella (g), right exocanthion (exR), left exocanthion (exL), right endocanthion (enR), left endocanthion (enL), pronasale (prn), right alare (alR), left alare (alL), subnasale (sn), labiale superius (ls), labiale inferius (li), right chelion (chR), left chelion (chL), pogonion (pg).
In all groups, A reference scan will be acquired in the form of a cast driven through alginate impression, then the cast will be scanned by desktop scanner. Scanning will be exported as a standard tessellation language (STL).
3D face scanning systems: Three scanning modalities will be tested. All scans will be conducted by the same operator in identical lighting, temperature (24°C), pressure (760 mmHg), and humidity (45%) conditions. In all scans, the head position will be standardized by a head-chin rest.
Group I: Handheld scanner (Metismile; Shining 3D, China):
Uses an infrared structured light system with a VCSEL projector. It contains three 1.3 MP cameras for data acquisition and one 5 MP texture camera. A series of scans will be taken each session took about 35 seconds. Scans will be captured according to manufacturer calibration protocols, processed in HD mode, and exported as PLY files.
Group II: Desktop scanner (RAYFace v2.0; Ray Co., Korea):
Employs white and blue structured light technology combined with depth and infrared sensors. The scanning duration will be approximately 0.5 seconds per scan. The scan will be taken following manufacturer guidelines, and scans will be exported in PLY format after HD processing Group III: Mobile face scanning application (Heges; Marek Simonik) on a smart device (iPad Pro X, Apple Inc., Cupertino, CA) It has a True Depth camera utilizing VCSEL technology, projecting 30,000 IR dots for depth mapping at a working distance of 300-450 mm. A tablet stand will be used for stability.
- An experienced single calibrated operator is going to do all the scans for each technique.
- Blinding techniques Single blinding will be done for the outcome assessor.
Method of evaluation:
A total of Sixty scans will be analyzed using (Geomagic metrology software). Inter-landmark distances will be digitally measured to assess three facial regions-upper, middle, and lower face-and categorized into vertical and horizontal dimensions. This boundary will be replicated on each of the experimental scans using a best-fit alignment technique. For each distance, trueness will be calculated as the mean absolute deviation from the reference measurements across all scans for each modality. Precision will be assessed by computing the standard deviation of the repeated measurements for each distance.
IX. Statistical Analysis The data will be collected, arranged, and tabulated to be statistically analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be divided into three groups;(I),(II) and(III).In all groups; 14 landmarks will be taken as reference points. A reference scan will be acquired in the form of a cast driven through alginate impression, then the cast will be scanned by desktop scanner. Scanning will be exported as a standard tessellation language (STL).Three scanning modalities will be tested. All scans will be conducted by the same operator in identical lighting, temperature (24°C), pressure (760 mmHg), and humidity (45%) conditions. In all scans, the head position will be standardized by a head-chin rest. Group I: Handheld scanner (Metismile; Shining 3D, China).Group II: Desktop scanner (RAYFace v2.0; Ray Co., Korea).Group III: Mobile face scanning (Heges; Marek Simonik) (iPad Pro X, Apple Inc., Cupertino, CA) .A tablet stand will be used for stability. An experienced single calibrated operator is going to do all the scans for each technique.
| Arm | Type | Receives |
|---|---|---|
| Handheld scanner | Experimental | Procedure: portable scanningA series of scans will be taken each session took about 35 seconds. Scans will be captured according to manufacturer calibration protocols, processed in HD mode, and exported as PLY files and superimposed on the reference scan. |
| stationery scanner | Experimental | Procedure: stationery scanningThe scanning duration will be approximately 0.5 seconds per scan. The scan will be taken following manufacturer guidelines, and scans will be exported in PLY format after HD processing and superimposed on the reference scan. |
| Mobile face scanning application | Experimental | Procedure: mobile app scanningA tablet stand will be used for stability. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Those who completed growth
Key exclusion criteria (2 listed)
- Men with beards.
- Those with maxillofacial deformity
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 |
|---|---|---|
| portable scanningface scanning will be made using a portable face scanner | Procedure or surgery | Handheld scanner |
| stationery scanningace scanning will be made using a stationery face scanner | Procedure or surgery | stationery scanner |
| mobile app scanningace scanning will be made using a mobile face scanning app | Procedure or surgery | Mobile face scanning application |
Primary outcome
accuracy measurement
Time frame: 7 months
Inter-landmark distances will be digitally measured to assess three facial regions-upper, middle, and lower face-and categorized into vertical and horizontal dimensions. This boundary will be replicated on each of the experimental scans using a best-fit alignment technique. For each distance, trueness will be calculated as the mean absolute deviation from the reference measurements across all scans for each modality. Precision will be assessed by computing the standard deviation of the repeated measurements for each distance.
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 7 May 2026.
- Individual participant dataSharing planned: Yes. Data will be provided once being available upon reasonable request from the principal investigator
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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.
Ahmed Mohamed, MD principal investigator
Faculty of dentistry, ain shams university
Questions about this trial
What is this clinical trial studying?
A study testing portable scanning, stationery scanning and mobile app scanning in people with Facial Neoplasms, run by Ain Shams University.
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 1 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: opening soon, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Mostafa Mohamed, MD (01111191337 ext. 002, ahmedmostafa@dent.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy measurement (time frame: 7 months). 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 7 May 2026.