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Precision of 3 Dimensional Facial Analysis Using Bellus 3D Face Camera Pro Versus Planmeca ProMax 3D Proface: A Diagnostic Accuracy Study

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ClinicalTrials.gov Identifier: NCT04511598
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Sally Faisal Mahmoud Fouad Abdallah, Cairo University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
3 Dimensional Soft Tissue Facial Analysis Device: "Bellus 3D Face Camera" Device: "Planmeca ProMax 3D Proface" Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Precision of 3 Dimensional Facial Analysis Using Bellus 3D Face Camera Pro Versus Planmeca ProMax 3D Proface: A Diagnostic Accuracy Study
Actual Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021
Arms and Interventions
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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.
 Device: "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: "Planmeca ProMax 3D Proface"
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.
 Device: "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: "Planmeca ProMax 3D Proface"
The lasers scan the facial geometry and the digital cameras capture the color texture of the face.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age range from 18-35 years.
  2. Normal balanced facial proportions.

Exclusion Criteria:

  1. Craniofacial anomalies.
  2. Obvious skeletal shifts.
  3. Patients with incompetent lips.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511598


Contacts
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Contact: Sally Faisal Mahmoud Fouad Abdallah +2 01061152623 sallyfaisalmira@gmail.com

Locations
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Egypt
Faculty of dentistry Recruiting
Cairo, Giza, Egypt, 12511
Contact: Sally Faisal Mahmoud Fouad Abdallah    +201061152623    sallyfaisalmira@gmail.com   
Sponsors and Collaborators
Cairo University
More Information
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Responsible Party: Sally Faisal Mahmoud Fouad Abdallah, Masters Degree Student, Cairo University
ClinicalTrials.gov Identifier: NCT04511598    
Other Study ID Numbers: ORTH 7-1-2
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Facies
Disease Attributes
Pathologic Processes