NCT07557212

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
May 2026Nov 2026

First Submitted

Initial submission to the registry

April 23, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 29, 2026

Completed
3 days until next milestone

Study Start

First participant enrolled

May 2, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

April 23, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

face scanning

Outcome Measures

Primary Outcomes (1)

  • accuracy measurement

    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

Study Arms (3)

Handheld scanner

EXPERIMENTAL

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

stationery scanner

EXPERIMENTAL

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

Mobile face scanning application

EXPERIMENTAL

A tablet stand will be used for stability.

Procedure: mobile app scanning

Interventions

face scanning will be made using a portable face scanner

Handheld scanner

ace scanning will be made using a stationery face scanner

stationery scanner

ace scanning will be made using a mobile face scanning app

Mobile face scanning application

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Those who completed growth

You may not qualify if:

  • Men with beards.
  • Those with maxillofacial deformity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Facial Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasms

Study Officials

  • Ahmed Mohamed, MD

    Faculty of dentistry, ain shams university

    PRINCIPAL INVESTIGATOR

Central Study Contacts

ahmed Mostafa Mohamed, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Single blinding will be done for the outcome assessor.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Participants will be divided into three groups;(I),(II) and(III).In all groups; 14 landmarks will be taken as reference points. 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).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).Group II: Desktop scanner (RAYFace v2.0; Ray Co., Korea).Group III: Mobile face scanning (Heges; Marek Simonik) (iPad Pro X, Apple Inc., Cupertino, CA) .A tablet stand will be used for stability. An experienced single calibrated operator is going to do all the scans for each technique.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Oral and Maxillofacial prosthodontics-Faculty of Dentistry- Ain Shams university

Study Record Dates

First Submitted

April 23, 2026

First Posted

April 29, 2026

Study Start

May 2, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

May 7, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
6 months