3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities

NCT06306326 | Not Yet Recruiting DMC

• 1 other identifier: pkussfatgrafting
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Adipocytes; Autografts; Imaging, Three-Dimensional / Methods

Keywords

Autologous Fat Grafting; 3dMD

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks postoperative and 1 year postoperative.

Secondary Outcomes (1)

• Patient Satisfaction

  4 weeks postoperative and 1 year postoperative.

Study Arms (1)

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.

Diagnostic Test: 3dMD technology

Interventions

3dMD technology DIAGNOSTIC_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.

3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities

Eligibility Criteria

• Age: 3 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Officials

• Xi Gong, Dr

  Peking University School and Hospital of Stomatology

  STUDY DIRECTOR

Central Study Contacts

Xi Gong, Dr

CONTACT

+86-15201304426; 15201304426@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: March 12, 2024
• Study Start: April 15, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: April 18, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share