3 Dimensional Soft Tissue Facial AnalysisNCT04511598
Precision of 3 Dimensional Facial Analysis Using Bellus 3D Face Camera Pro Versus Planmeca ProMax 3D Proface: A Diagnostic Accuracy Study
A study testing "Bellus 3D Face Camera" and "Planmeca ProMax 3D Proface" in people with 3 Dimensional Soft Tissue Facial Analysis, run by Cairo University at 1 site in Egypt.
Trial summary
Precision of 3 Dimensional Facial Analysis Using "Bellus 3D Face Camera Pro" Versus "Planmeca ProMax 3D Proface" is to be evaluated in comparison to direct anthropometry. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- 3 Dimensional Soft Tissue Facial Analysis
- What is being tested?
- "Bellus 3D Face Camera" and "Planmeca ProMax 3D Proface"
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to Aug 2021
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age range from 18-35 years.
- Normal balanced facial proportions.
Who cannot join
- Craniofacial anomalies.
- Obvious skeletal shifts.
- Patients with incompetent lips.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of dentistry
Cairo, Giza Governorate, 12511
Sally Faisal Mahmoud Fouad Abdallah, +201061152623, sallyfaisalmira@gmail.com
About this study
Precision of 3 Dimensional Facial Analysis Using "Bellus 3D Face Camera Pro" Versus "Planmeca ProMax 3D Proface" is to be evaluated in comparison to direct anthropometry.
Read the detailed description
The aim of this study will be the evaluation of the precision and reproducibility of standard anthropometric linear measurements made with two different three-dimensional imaging systems namely "Bellus 3D Face Camera Pro" and "Planmeca ProMax 3D ProFace system" and to compare them to physical linear measurements "Direct Anthropometry".
- Being tested
- "Bellus 3D Face Camera", "Planmeca ProMax 3D Proface"
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Bellus 3D Face Camera"Device
The depth sensor uses infrared structured light scanning technology to capture depth and the camera on the phone or tablet to capture color texture of the face.
"Planmeca ProMax 3D Proface"Device
The lasers scan the facial geometry and the digital cameras capture the color texture of the face.
| Study group | Role | What they receive |
|---|---|---|
| Bellus 3D Face Camera Pro | Experimental | Every single patient will be diagnosed using 3D imaging system "Bellus 3D Face Camera Pro" to be compared to the direct measurements obtained from direct anthropometry. Receives: Device: "Bellus 3D Face Camera"; Device: "Planmeca ProMax 3D Proface" |
| Planmeca ProMax 3D Proface | Experimental | Every single patient will be diagnosed using 3D imaging systems "Planmeca ProMax 3D Proface" to be compared to the direct measurements obtained from direct anthropometry. Receives: Device: "Bellus 3D Face Camera"; Device: "Planmeca ProMax 3D Proface" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precision
Evaluation of the precision of standard anthropometric linear measurements made with two different three-dimensional imaging systems namely Bellus 3D Face Camera Pro and Planmeca ProMax 3D ProFace system and to compare them to physical linear measurements.
Measured: 1 Month
Secondary outcomes (1)
Reproducibility
Evaluation of the reproducibility of standard anthropometric linear measurements made with two different three-dimensional imaging systems namely Bellus 3D Face Camera Pro and Planmeca ProMax 3D ProFace system and to compare them to physical linear measurements.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start1 Mar 2020
- Primary completionMar 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 3 Dimensional Soft Tissue Facial AnalysisStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sally Faisal Mahmoud Fouad Abdallah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511598
- Sponsor's protocol ID
- ORTH 7-1-2
- Status last verified
- Aug 2020
- First submitted
- 9 Aug 2020
- Last updated
- 13 Aug 2020
- 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 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision of 3 Dimensional Facial Analysis Using Bellus 3D Face Camera Pro Versus Planmeca ProMax 3D Proface: A Diagnostic Accuracy Study
- ClinicalTrials.gov ID
- NCT04511598
- Acronym / sponsor ID
- ORTH 7-1-2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 13 Aug 2020 (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.
Precision of 3 Dimensional Facial Analysis Using "Bellus 3D Face Camera Pro" Versus "Planmeca ProMax 3D Proface" is to be evaluated in comparison to direct anthropometry.
Detailed description
The aim of this study will be the evaluation of the precision and reproducibility of standard anthropometric linear measurements made with two different three-dimensional imaging systems namely "Bellus 3D Face Camera Pro" and "Planmeca ProMax 3D ProFace system" and to compare them to physical linear measurements "Direct Anthropometry".
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bellus 3D Face Camera Pro | Experimental | Device: "Bellus 3D Face Camera", Device: "Planmeca ProMax 3D Proface"Every single patient will be diagnosed using 3D imaging system "Bellus 3D Face Camera Pro" to be compared to the direct measurements obtained from direct anthropometry. |
| Planmeca ProMax 3D Proface | Experimental | Device: "Bellus 3D Face Camera", Device: "Planmeca ProMax 3D Proface"Every single patient will be diagnosed using 3D imaging systems "Planmeca ProMax 3D Proface" to be compared to the direct measurements obtained from direct anthropometry. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age range from 18-35 years.
- Normal balanced facial proportions.
Key exclusion criteria (3 listed)
- Craniofacial anomalies.
- Obvious skeletal shifts.
- Patients with incompetent lips.
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 |
|---|---|---|
| "Bellus 3D Face Camera"The depth sensor uses infrared structured light scanning technology to capture depth and the camera on the phone or tablet to capture color texture of the face. | Device | Bellus 3D Face Camera Pro, Planmeca ProMax 3D Proface |
| "Planmeca ProMax 3D Proface"The lasers scan the facial geometry and the digital cameras capture the color texture of the face. | Device | Bellus 3D Face Camera Pro, Planmeca ProMax 3D Proface |
Primary outcome
Precision
Time frame: 1 Month
Evaluation of the precision of standard anthropometric linear measurements made with two different three-dimensional imaging systems namely Bellus 3D Face Camera Pro and Planmeca ProMax 3D ProFace system and to compare them to physical linear measurements.
1 secondary outcome
Reproducibility
Time frame: 1 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
Related trials for 3 Dimensional Soft Tissue Facial Analysis
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 "Bellus 3D Face Camera" and "Planmeca ProMax 3D Proface" in people with 3 Dimensional Soft Tissue Facial Analysis, 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 2 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: status not confirmed, as of the sponsor's last update on 13 Aug 2020. 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 Sally Faisal Mahmoud Fouad Abdallah (+2 01061152623, sallyfaisalmira@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Precision (time frame: 1 Month). 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 13 Aug 2020.