A multicenter randomized clinical study of using a three-dimensional printed patient personalized titanium plate in jaw surgery
| ISRCTN | ISRCTN11838566 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11838566 |
| Secondary identifying numbers | LCYJ2020-YF-1, ChiCTR2200060289 |
- Submission date
- 21/05/2022
- Registration date
- 06/06/2022
- Last edited
- 26/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
Background and study aims
Jaw surgeries commonly use a titanium alloy for bone fixation for many characteristics such as its light weight, high strength, corrosion resistance and good biocompatibility. The most commonly used plates for bone fixation are commercially available and are produced and casted according to the fixed shape of the mold, but the irregular shapes of jaw bone surfaces make these commercially available plates unable to completely fit to the contour of different bone surfaces and need bending to get an appropriate approximation between the bone parts. Plate bending wastes operation time, increases the operation risk and sheds off the protective surface of the titanium plate. Therefore, the construction of 3D-printed patient personalized titanium plates will overcome such problems in bone fixation. The aim of this study is to assess using a 3D-printed patient personalized titanium plate in jaw surgery.
Who can participate?
Patients aged 18-45 years with dentofacial (teeth/face) deformities requiring jaw surgery
What does the study involve?
The patients are randomly divided into the 3D printed personalized titanium plate group and the commercial titanium plate group. The follow-up for the treatment is 6 months after the jaw correction surgery and at the end of the sixth month the patients will be admitted for the removal of the titanium plates.
What are the possible benefits and risks of participating?
There is evidence that 3D-printed personalized titanium plates can improve the accuracy of jaw surgery, reduces the operation time and minimizes risks during the operation. The participants' condition may or may not improve moreover or there may be the following risks and discomfort. Although the titanium alloy material in this study has been tested in animals to ensure the safety of the product before its use in a clinical trial, uncertainty still exists regarding its clinical effects. Risks associated with the surgery include swelling, general rejection, local infection and inflammation, and wound dehiscence (separation of the edges of a surgical wound).
Where is the study run from?
West China Hospital of Stomatology, Sichuan University (China)
When is the study starting and how long is it expected to run for?
January 2020 to June 2024
Who is funding the study?
West China Hospital of Stomatology, Sichuan University (China)
Who is the main contact?
Dr Wael Telha
doctorzhu@scu.edu.cn
Contact information
Principal Investigator
No. 14, Section 3
Ren Min Nan Road
Chengdu
610041
China
| Phone | +86 (0)19182163717 |
|---|---|
| doctorzhu@scu.edu.cn |
Study information
| Study design | Prospective randomized multi-center interventional clinical trial study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | 41803_PIS_V3_ChineseVersion.pdf |
| Scientific title | A prospective, multicenter, randomized, clinical controlled trial of using a three-dimensional printed patient personalized titanium plate in orthognathic surgery |
| Study objectives | This study is designed to compare the effect of using a 3D printed personalized titanium plate and commercially available titanium plates in orthognathic surgery on the operation time and the accuracy of post-operative bone positioning. |
| Ethics approval(s) | Approved 24/06/2020, Medical Ethics Committee, West China Hospital of stomatology, Sichuan University (Hospital Management Office, West China Medical Center, Building 1, West China East Campus, no. 28 South Telecom Street, Wuhou District, Chengdu, China; +86 (0)28-85503401; yxglc@scu.edu.cn), ref: not provided |
| Health condition(s) or problem(s) studied | Management of dentofacial deformities through an orthognathic surgical intervention |
| Intervention | A prospective, randomized multi-center clinical trial study planned to compare the accuracy of bone positioning following orthognathic surgery between 3D printed personalized titanium plates patient group and traditionally available titanium plates. The patients are randomly divided into the 3D printed personalized titanium plate group and the commercial titanium plate group. This study could not be blinded to surgeons, but the participants and evaluators are blinded. The follow-up for the treatment is 6 months after the jaw correction surgery and at the end of the sixth month the patients will be admitted for the removal of the titanium plates. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | 3D-printed personalized titanium plates |
| Primary outcome measure | The accuracy of using 3D printed titanium plates through evaluation of the post-operative CT scan with the pre-operative 3D planning using a 3D Slicer software program |
| Secondary outcome measures | Current secondary outcome measures as of 05/06/2024: Long-term stability of the 3d printed personalized plates used in orthognathic surgery Any abnormalities related to the use of 3D plating were assessed using a blood sample before and after the surgery _____ Previous secondary outcome measures: Any abnormalities related to the use of 3D plating assessed using a blood sample before and after the surgery |
| Overall study start date | 01/01/2020 |
| Completion date | 30/06/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Both |
| Target number of participants | 100 |
| Key inclusion criteria | 1. Patients with dentofacial malformations requiring orthognathic surgery 2. Aged 18-45 years 3. Willing to participate in the clinical study and sign informed consent of meeting the above-mentioned criteria |
| Key exclusion criteria | 1. Patient with maxillofacial deformities secondary to cleft lip and palate, tumor, trauma and other congenital factors 2. Patients with syndromes such as hemifacial microsomia, first and second arch syndrome, etc 3. Patients who had undergone previous jaw surgery |
| Date of first enrolment | 20/07/2022 |
| Date of final enrolment | 20/01/2024 |
Locations
Countries of recruitment
- China
Study participating centres
Ren Min Nan Road
Chengdu
610041
China
Chaoyang District
Changchun
130021
China
Shenzhen
518055
China
Sponsor information
Hospital/treatment centre
No. 14, Section 3
Ren Min Nan Road
Chengdu
610041
China
| Phone | +86 (0)28 85503401 |
|---|---|
| hxkqdean@scu.edu.cn | |
| Website | https://hxkq.org/Html/News/Main/220.html |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | The team of this project is planning to publish the results in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 3 | 31/05/2022 | No | Yes | |
| Participant information sheet | version 3 | 31/05/2022 | No | Yes | |
| Protocol file | 31/05/2022 | No | No | ||
| Statistical Analysis Plan | 06/06/2024 | No | No | ||
| Basic results | Primary outcome measure | 26/06/2024 | No | No | |
| Dataset | Primary outcome measure | 26/06/2024 | No | No |
Additional files
Editorial Notes
26/06/2024: The following changes were made to the trial record:
1. The basic results have been uploaded as an additional file.
2. A dataset was uploaded as an additional file.
17/06/2024: The study participating centre Guiyang Hospital of Stomatology was removed.
06/06/2024: The statistical analysis plan was uploaded as an additional file.
05/06/2024: The following changes were made to the trial record:
1. The secondary outcome measures were changed.
2. The study participating centre Southern Medical University Hospital of Stomatology (Guangdong Stomatology Hospital) was removed and Shenzhen University Affiliated Shenzhen Stomatological Hospital
was added.
31/05/2022: Trial's existence confirmed by the Medical Ethics Committee, West China Hospital of Stomatology, Sichuan University.
