Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06306326
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-02-27
Brief Title:
3D Facial Scanning for Evaluating Autologous Fat Grafting in Craniofacial Deformities
Sponsor:
Peking University
Organization:
Peking University
Study Overview
Official Title:
Application of Three-dimensional Facial Scanning Images in Evaluating the Therapeutic Efficacy of Autologous Fat Grafting in the Treatment of Craniofacial Deformities
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None