A Comparison of Accuracy Between Different Facial Scanning Techniques

May 2, 2026 updated by: Ahmed Mostafa Abdelfatah, Ain Shams University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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)

  1. 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.

  2. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Those who completed growth

Exclusion Criteria:

  • Men with beards.
  • Those with maxillofacial deformity

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Handheld scanner
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.
Procedure: portable scanning
face scanning will be made using a portable face scanner
Experimental: stationery scanner
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.
Procedure: stationery scanning
ace scanning will be made using a stationery face scanner
Experimental: Mobile face scanning application
A tablet stand will be used for stability.
Procedure: mobile app scanning
ace scanning will be made using a mobile face scanning app

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ain Shams University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ahmed Mohamed, MD, Faculty of Dentistry, Ain Shams University

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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDASU-REC IR/M 122503

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be provided once being available upon reasonable request from the principal investigator

IPD Sharing Time Frame

6 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

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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