AdipocytesNCT06306326
3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities
A study testing 3dMD technology in people with Adipocytes and Autografts, run by Peking University at 1 site in China.
Trial summary
Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. Read more about this study
- Who is it for?
- Ages 3 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Adipocytes, Autografts, Imaging, Three-Dimensional / Methods
- What is being tested?
- 3dMD technology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 27 Apr 2024to 15 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Facial soft tissue volume deficiency deformity caused by congenital/acquired factors, meeting the indications for autologous fat grafting surgery.
- Good physical health, without severe systemic diseases or infectious diseases.
- Not pregnant and without plans for pregnancy.
- Signed informed consent form.
Who cannot join
- Contraindications to general anesthesia.
- Patient refusal to participate in this study.
- Significant contour changes in non-filled facial areas during follow-up period leading to inability to register data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University School and Hospital of Stomatology
Beijing, Beijing Municipality, 100081
Gong X Xi Gong, DDS, +86-15201304426, gongx31480528@163.com
About this study
Official title: Application of Three-dimensional Facial Scanning Images in Evaluating the Therapeutic Efficacy of Autologous Fat Grafting in the Treatment of Craniofacial Deformities
Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis.
Read the detailed description
Craniofacial deformities are common facial abnormalities that can significantly affect patients' appearance and oral function, leading to profound impacts on their psychological and quality of life. Autologous fat grafting has been used since the early 20th century for facial filling, offering advantages such as using the patient's own tissues, minimal risk of rejection, and providing a natural appearance. Therefore, it has become a popular method in plastic surgery and widely used to treat various types of facial deformities. However, the technique also presents clinical challenges, as the transplanted fat cells need sufficient blood supply in the new location to survive and maintain their volume. During the process, a portion of the transplanted fat tissue without blood supply will be absorbed. Generally, the absorption rate of transplanted fat tissue varies from 30% to 70% depending on factors such as location, surgical technique, time, and individual differences, leading to unstable outcomes. Factors affecting the survival rate of fat particles after transplantation include infection, poor blood supply in the recipient area, age, physique, nutrition, mental state, and the duration of the deformity. Shallow depressions have a lower absorption rate, while deeper ones have a higher absorption rate. Postoperative immobilization of the transplanted fat area is necessary to rebuild blood circulation. However, there is no literature reporting the exact impact of these factors on the absorption rate of fat grafts. Therefore, it is suggested that autologous fat grafting should be performed using the "small amount multiple times" method for timely correction.
In addition to being influenced by surgical techniques and individual differences, a more significant issue is the lack of accuracy in assessing the effectiveness of this technique. Previous evaluation methods include subjective assessment and objective evaluation methods such as cephalometric measurements. However, these methods have various degrees of inaccuracy in evaluating soft tissue volume changes. The emergence of the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology is expected to solve this problem. 3dMD technology, full name 3D facial scanning imaging technology, uses binocular vision principles to rapidly capture three-dimensional data of the face, providing high-precision facial morphology information. It is accurate, fast, and radiation-free, and literature suggests it is the preferred method for evaluating the results of facial soft tissue volume recovery surgery. The application of 3dMD technology can help achieve precise measurements of facial volume before and after fat grafting, providing a powerful tool for studying fat absorption rates.
This study is an observational study that will use 3dMD technology to accurately measure changes in facial volume before and after autologous fat grafting by scanning the patient's face in three dimensions. This will provide accurate fat absorption or retention rates and study the impact of individual factors on treatment outcomes through regression analysis. This will help better understand the effectiveness of autologous fat grafting technology and provide a scientific basis for the treatment of craniofacial deformities.
- Conditions
- Adipocytes, Autografts, Imaging, Three-Dimensional / Methods
- Being tested
- 3dMD technology
- Keywords
- Autologous Fat Grafting, 3dMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3dMD technologyDiagnostic test
By taking photos using 3dMD, we obtained preoperative, immediate postoperative, and long-term postoperative three-dimensional data of patients. The software automatically fused the data to obtain the volume difference of facial volume at different time points, and then divided it to obtain the objective data of facial volume improvement rate. To improve the reliability of the measurements, two researchers measured independently and took the average value.
| Study group | Role | What they receive |
|---|---|---|
| 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities | Experimental | By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis. Receives: Diagnostic Test: 3dMD technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fat Retention Rate
Using 3dMD technology, facial profiles were captured preoperatively and postoperatively. The postoperative profiles were matched with the preoperative ones and processed using Boolean operations to obtain the volume difference, which represents the volume of grafted fat. The fat retention rate was calculated by dividing the volume of grafted fat obtained at 1 year postoperatively by the volume obtained at 1 month postoperatively.
Measured: 4 weeks postoperative and 1 year postoperative.
Secondary outcomes (1)
Patient Satisfaction
Patient satisfaction with the improvement in facial appearance was assessed using a Visual Analog Scale (VAS).
Measured: 4 weeks postoperative and 1 year postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start27 Apr 2024
- Primary completion27 May 2028 (estimated)
- Study completion15 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdipocytesStudies of the same condition, open and under way.
- More trials run by Peking 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xi Gong, Dr, Study director, Peking University School and Hospital of Stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306326
- Sponsor's protocol ID
- pkussfatgrafting
- Status last verified
- Jun 2026
- First submitted
- 27 Feb 2024
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Three-dimensional Facial Scanning Images in Evaluating the Therapeutic Efficacy of Autologous Fat Grafting in the Treatment of Craniofacial Deformities
- ClinicalTrials.gov ID
- NCT06306326
- Acronym / sponsor ID
- pkussfatgrafting
- Conditions
- Adipocytes, Autografts, Imaging, Three-Dimensional / Methods
- Keywords
- Autologous Fat Grafting, 3dMD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 27 Apr 2024 (actual)
- Primary completion
- 27 May 2028 (estimated)
- Study completion
- 15 Apr 2029 (estimated)
- First posted
- 12 Mar 2024 (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.
Treatment of craniofacial deformities is a significant topic in oral and maxillofacial surgery, and autologous fat grafting has become one of the main methods for treating facial concave deformities. However, the instability of its treatment effect has always been a bottleneck in this field, mainly due to the uncertain absorption rate of transplanted fat. This project aims to use advanced the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology to precisely measure the facial volume changes before and after autologous fat grafting to address this issue. By performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis.
Detailed description
Craniofacial deformities are common facial abnormalities that can significantly affect patients' appearance and oral function, leading to profound impacts on their psychological and quality of life. Autologous fat grafting has been used since the early 20th century for facial filling, offering advantages such as using the patient's own tissues, minimal risk of rejection, and providing a natural appearance. Therefore, it has become a popular method in plastic surgery and widely used to treat various types of facial deformities. However, the technique also presents clinical challenges, as the transplanted fat cells need sufficient blood supply in the new location to survive and maintain their volume. During the process, a portion of the transplanted fat tissue without blood supply will be absorbed. Generally, the absorption rate of transplanted fat tissue varies from 30% to 70% depending on factors such as location, surgical technique, time, and individual differences, leading to unstable outcomes. Factors affecting the survival rate of fat particles after transplantation include infection, poor blood supply in the recipient area, age, physique, nutrition, mental state, and the duration of the deformity. Shallow depressions have a lower absorption rate, while deeper ones have a higher absorption rate. Postoperative immobilization of the transplanted fat area is necessary to rebuild blood circulation. However, there is no literature reporting the exact impact of these factors on the absorption rate of fat grafts. Therefore, it is suggested that autologous fat grafting should be performed using the "small amount multiple times" method for timely correction.
In addition to being influenced by surgical techniques and individual differences, a more significant issue is the lack of accuracy in assessing the effectiveness of this technique. Previous evaluation methods include subjective assessment and objective evaluation methods such as cephalometric measurements. However, these methods have various degrees of inaccuracy in evaluating soft tissue volume changes. The emergence of the 3dMD face system (3dMD) (3dMD Inc, Atlanta, Ga) technology is expected to solve this problem. 3dMD technology, full name 3D facial scanning imaging technology, uses binocular vision principles to rapidly capture three-dimensional data of the face, providing high-precision facial morphology information. It is accurate, fast, and radiation-free, and literature suggests it is the preferred method for evaluating the results of facial soft tissue volume recovery surgery. The application of 3dMD technology can help achieve precise measurements of facial volume before and after fat grafting, providing a powerful tool for studying fat absorption rates.
This study is an observational study that will use 3dMD technology to accurately measure changes in facial volume before and after autologous fat grafting by scanning the patient's face in three dimensions. This will provide accurate fat absorption or retention rates and study the impact of individual factors on treatment outcomes through regression analysis. This will help better understand the effectiveness of autologous fat grafting technology and provide a scientific basis for the treatment of craniofacial deformities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities | Experimental | Diagnostic Test: 3dMD technologyBy performing autologous fat grafting surgery on 100 patients with craniofacial deformities that meet the research criteria, 3dMD technology will be used for facial three-dimensional scanning preoperatively, immediately postoperatively, and at six months postoperatively to obtain facial volume data. Then, through precise data analysis, we will calculate the fat absorption rate and study the effects of individual factors on treatment outcomes through correlation regression analysis. |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Facial soft tissue volume deficiency deformity caused by congenital/acquired factors, meeting the indications for autologous fat grafting surgery.
- Good physical health, without severe systemic diseases or infectious diseases.
- Not pregnant and without plans for pregnancy.
- Signed informed consent form.
Key exclusion criteria (3 listed)
- Contraindications to general anesthesia.
- Patient refusal to participate in this study.
- Significant contour changes in non-filled facial areas during follow-up period leading to inability to register data.
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 |
|---|---|---|
| 3dMD technologyBy taking photos using 3dMD, we obtained preoperative, immediate postoperative, and long-term postoperative three-dimensional data of patients. The software automatically fused the data to obtain the volume difference of facial volume at different time points, and then divided it to obtain the objective data of facial volume improvement rate. To improve the reliability of the measurements, two researchers measured independently and took the average value. | Diagnostic test | 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities |
Primary outcome
Fat Retention Rate
Time frame: 4 weeks postoperative and 1 year postoperative.
Using 3dMD technology, facial profiles were captured preoperatively and postoperatively. The postoperative profiles were matched with the preoperative ones and processed using Boolean operations to obtain the volume difference, which represents the volume of grafted fat. The fat retention rate was calculated by dividing the volume of grafted fat obtained at 1 year postoperatively by the volume obtained at 1 month postoperatively.
1 secondary outcome
Patient Satisfaction
Time frame: 4 weeks postoperative and 1 year postoperative.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 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.
Xi Gong, Dr study director
Peking University School and Hospital of Stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3dMD technology in people with Adipocytes and Autografts, run by Peking University at 1 site in China.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Jun 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xi Gong, Dr (+86-15201304426, 15201304426@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fat Retention Rate (time frame: 4 weeks postoperative and 1 year postoperative.). 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 9 Jun 2026.