- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04511598
Precision of 3 Dimensional Facial Analysis Using Bellus 3D Face Camera Pro Versus Planmeca ProMax 3D Proface: A Diagnostic Accuracy Study
August 11, 2020 updated by: Sally Faisal Mahmoud Fouad Abdallah, Cairo University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sally Faisal Mahmoud Fouad Abdallah
- Phone Number: +2 01061152623
- Email: sallyfaisalmira@gmail.com
Study Locations
-
-
Giza
-
Cairo, Giza, Egypt, 12511
- Recruiting
- Faculty of Dentistry
-
Contact:
- Sally Faisal Mahmoud Fouad Abdallah
- Phone Number: +201061152623
- Email: sallyfaisalmira@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age range from 18-35 years.
- Normal balanced facial proportions.
Exclusion Criteria:
- Craniofacial anomalies.
- Obvious skeletal shifts.
- Patients with incompetent lips.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bellus 3D Face Camera Pro
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.
|
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.
The lasers scan the facial geometry and the digital cameras capture the color texture of the face.
|
Experimental: 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.
|
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.
The lasers scan the facial geometry and the digital cameras capture the color texture of the face.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reproducibility
Time Frame: 1 Month
|
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.
|
1 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2020
Primary Completion (Anticipated)
March 1, 2021
Study Completion (Anticipated)
August 1, 2021
Study Registration Dates
First Submitted
August 9, 2020
First Submitted That Met QC Criteria
August 11, 2020
First Posted (Actual)
August 13, 2020
Study Record Updates
Last Update Posted (Actual)
August 13, 2020
Last Update Submitted That Met QC Criteria
August 11, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTH 7-1-2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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