Lidar-based Scanning of Fascial Edema (FE) (FE)

July 2, 2026 updated by: Gözde Işık, Ege University

Handheld vs Mechanically-assisted Scanning of Fascial Edema Following Impacted Third Molar Surgery

This study compared handheld and mechanically assisted scanning to evaluate fascial edema after third molar extraction. The flexible ruler served as the reference. Linear measurements were taken from the tragus to the pogonion, from the tragus to the corner of the mouth, and from the lateral corner of the eye to the angle of the mandible.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

This study compared Lidar-based scanning methods for evaluating fascial edema after third molar extraction. The three methods assessed were flexible ruler measurement, handheld scanning, and mechanically assisted scanning. Lidar-based scanning was performed using a mobile device and a dedicated application. Linear measurements were obtained from the tragus to the pogonion, from the tragus to the corner of the mouth, and from the lateral canthus to the angle of the mandible. The study objectives were to compare scanning methods, evaluate acquisition time and the number of repeated scans required for mobile scanning, and assess patient-related outcomes using a questionnaire.

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.
Observational

Enrollment (Actual)

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.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

20 healthy patients enrolled with bilateral or unilateral impacted mandibular third molars. Impaction classification was Pell and Gregory Level B and Winter Class II (vertical position).

Description

Inclusion Criteria:

  • Presence of at least one impacted mandibular third molar,
  • Complete root development of the impacted tooth,
  • Impaction classified as Pell and Gregory Level B and Winter Class II (vertical position)

Exclusion Criteria:

  • Pregnancy or lactation;
  • Neurological, endocrine, or psychiatric disorders associated with tremor or hereditary disorders affecting motor function,
  • Facial asymmetry, facial deformity, or facial hair that could interfere with facial contour assessment;
  • Current or planned use of medications that may influence postoperative facial edema, such as corticosteroids;
  • Presence of chronic conditions that could mimic facial edema or a history of complications such as hematoma or subcutaneous emphysema.

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
20 patients extracted impacted mandibular third molars
20 patients extracted unilaterally ot bilaterally mandibular third molars. Impaction classified as Pell and Gregory Level B and Winter Class II (vertical position)
Procedure: Measurement with flexible ruler
linear measurements were obtained directly using a flexible ruler marked in millimeters
Procedure: Measurement with handheld scanning
Face image of patients were collected using a LiDAR-equipped mobile device and the three dimensional scanning application. A researcher was manually moved around the participant's head along a horizontal trajectory until complete facial coverage and adequate mesh reconstruction.
Procedure: Measurement with mechanically assisted scanning
Face image of patients were collected using a LiDAR-equipped mobile device and the three dimensional scanning application. For recording, the device is positioned on a mechanism.

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
Collect fascial anthropometric measurement
Time Frame: At postoperative first week
The measurement of the distances between the tragus and pogonion, the tragus and labial commissure, and the angle of mandible and lateral canthus with the use of a flexible ruler, handheld scanning, and mechanically assisted scanning.
At postoperative first week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Collect of image acquisition time
Time Frame: At postoperative first week
The duration required to complete facial recordings using both handheld scanning and mechanically assisted scanning.
At postoperative first week
Collect of the number of repeated scans
Time Frame: At postoperative first week
Required repetitions for capturing facial recordings using handheld scanning or mechanically assisted scanning.
At postoperative first week
Collect of patient reported outcomes
Time Frame: At postoperative 7th day
A questionnaire was used to assess patient's perception to measurement methods
At postoperative 7th day

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.
Ege University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Scientific and Technological Research Council of Turkey

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)

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.
December 1, 2025

Primary Completion (Actual)

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.
March 1, 2026

Study Completion (Actual)

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.
June 3, 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).
July 2, 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.
July 2, 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.
July 8, 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.
July 8, 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.
July 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.
July 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.
  • 325S877
  • 324S877 (Other Identifier: Tübitak 1002-A)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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