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

Sponsor

Cairo University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04511598

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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"	N/A

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

Study Type:

Interventional

Anticipated 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 :

Mar 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2021

Anticipated Study Completion Date :

Aug 1, 2021

Arms and Interventions

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.

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

Primary Outcome Measures

Precision [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

Reproducibility [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

Criteria

Ages Eligible for Study:

18 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

Craniofacial anomalies.
Obvious skeletal shifts.
Patients with incompetent lips.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of dentistry	Cairo	Giza	Egypt	12511

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Aug 13, 2020

Last Update Posted:

Aug 13, 2020

Last Verified:

Aug 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Facies

Study Results

No Results Posted as of Aug 13, 2020