Edema FaceFENCT07690488
Lidar-based Scanning of Fascial Edema (FE)
An observational study of Edema Face and Scanning Devices, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Edema Face, Scanning Devices
- What is being tested?
- Measurement with flexible ruler, Measurement with handheld scanning and Measurement with mechanically assisted scanning
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 3 Jun 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Edema Face, Scanning Devices
- Being tested
- Measurement with flexible ruler, Measurement with handheld scanning, Measurement with mechanically assisted scanning
- Keywords
- Fascial edema, Lidar-based scanning, mobile device, mechanically assisted, handheld, flexible ruler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement with flexible rulerProcedure or surgery
linear measurements were obtained directly using a flexible ruler marked in millimeters
Measurement with handheld scanningProcedure or surgery
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.
Measurement with mechanically assisted scanningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Procedure: Measurement with flexible ruler; Procedure: Measurement with handheld scanning; Procedure: Measurement with mechanically assisted scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect fascial anthropometric measurement
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.
Measured: At postoperative first week
Secondary outcomes (3)
Collect of image acquisition time
The duration required to complete facial recordings using both handheld scanning and mechanically assisted scanning.
Measured: At postoperative first week
Collect of the number of repeated scans
Required repetitions for capturing facial recordings using handheld scanning or mechanically assisted scanning.
Measured: At postoperative first week
Collect of patient reported outcomes
A questionnaire was used to assess patient's perception to measurement methods
Measured: At postoperative 7th day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start1 Dec 2025
- Primary completion1 Mar 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edema FaceStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Responsible party
- Principal investigator, Gözde Işık, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07690488
- Sponsor's protocol ID
- 325S877
- Other IDs
- 324S877
- Acronym
- FE
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Handheld vs Mechanically-assisted Scanning of Fascial Edema Following Impacted Third Molar Surgery
- ClinicalTrials.gov ID
- NCT07690488
- Acronym / sponsor ID
- FE / 325S877
- Conditions
- Edema Face, Scanning Devices
- Keywords
- Fascial edema, Lidar-based scanning, mobile device, mechanically assisted, handheld, flexible ruler
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- The Scientific and Technological Research Council of Turkey
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 20 patients extracted impacted mandibular third molars | – | Procedure: Measurement with flexible ruler, Procedure: Measurement with handheld scanning, Procedure: Measurement with mechanically assisted scanning20 patients extracted unilaterally ot bilaterally mandibular third molars. Impaction classified as Pell and Gregory Level B and Winter Class II (vertical position) |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement with flexible rulerlinear measurements were obtained directly using a flexible ruler marked in millimeters | Procedure or surgery | 20 patients extracted impacted mandibular third molars |
| Measurement with handheld scanningFace 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 or surgery | 20 patients extracted impacted mandibular third molars |
| Measurement with mechanically assisted scanningFace 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. | Procedure or surgery | 20 patients extracted impacted mandibular third molars |
Primary outcome
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.
3 secondary outcomes
Collect of image acquisition time
Time frame: At postoperative first week
Collect of the number of repeated scans
Time frame: At postoperative first week
Collect of patient reported outcomes
Time frame: At postoperative 7th day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edema Face and Scanning Devices, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect fascial anthropometric measurement (time frame: At postoperative first week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.