Clinical trial NCT06306326: 3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities
Official title: Application of Three-dimensional Facial Scanning Images in Evaluating the Therapeutic Efficacy of Autologous Fat Grafting in the Treatment of Craniofacial Deformities
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Adipocytes
Autografts
Imaging, Three-Dimensional / Methods
Keywords: Autologous Fat Grafting
3dMD
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Fat Retention Rate
timeFrame: 4 weeks postoperative and 1 year postoperative.
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 4 weeks postoperative and 1 year postoperative.
Other outcomes:
Locations:
Study officials:
affiliation: Peking University School and Hospital of Stomatology
name: Xi Gong, Dr
role: STUDY_DIRECTOR
References: