- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07690488
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
-
-
Bornova
-
Izmir, Bornova, Turkey (Türkiye), 35550
- Ege University
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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)
|
linear measurements were obtained directly using a flexible ruler marked in millimeters
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.
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
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
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
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)
December 1, 2025
Primary Completion (Actual)
March 1, 2026
Study Completion (Actual)
June 3, 2026
Study Registration Dates
First Submitted
July 2, 2026
First Submitted That Met QC Criteria
July 2, 2026
First Posted (Actual)
July 8, 2026
Study Record Updates
Last Update Posted (Actual)
July 8, 2026
Last Update Submitted That Met QC Criteria
July 2, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID 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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