A comparison between traditional surgical technology and implant technology manufactured through 3D printing for nasal repair in patients with cleft lip
| ISRCTN | ISRCTN97129635 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN97129635 |
| Secondary identifying numbers | 0000 |
- Submission date
- 16/06/2024
- Registration date
- 21/06/2024
- Last edited
- 21/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Genetic Diseases
Plain English summary of protocol
Background and study aims
A cleft lip is one of the most common congenital clefts in the facial area. The nasal deformity following bilateral lip clefts has a severe and direct impact on the patient’s appearance and psychological health. Many severe deformities may hinder the patient’s breathing and speech, and many post-cleft nasal repair surgeries have chosen to cut cartilage grafts from the ribs (costal cartilaginous graft) because it has proven effective in obtaining excellent surgical results. In this study, the researchers attempt to avoid the disadvantages of traditional open-technique surgery in nasal repair by shortening the time and avoiding a second surgery for the donor area by using 3D printing and designing customized biocompatible silicone implants. This study will be the world's first controlled, randomized, two-group study that will compare the traditional surgical approach (rhinoplasty) with costal cartilaginous grafts and implants manufactured for nasal repair in patients with cleft lip.
Who can participate?
Patients aged 18 years and over undergoing cleft lip closure and needing nasal repair
What does the study involve?
Participants are randomly allocated to one of two groups. Patients in the control group will undergo rhinoplasty and receive a costal cartilaginous graft. Patients in the experimental group will undergo rhinoplasty and receive 3D-printed biocompatible silicone implants.
What are the possible benefits and risks of participating?
Possible benefits are restoring aesthetic, speech and breathing function for patients. Possible risks are on the same level as any surgical operation or procedure.
Where is the study run from?
Al-Assad Hospital (Syria)
When is the study starting and how long is it expected to run for?
January 2024 to April 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Dr Fatima Elmi, fatimaelmi14@gmail.com
2. Prof. Dr Bassel Brad, bassel.brad@damascusuniversity.edu.sy
3. PD Dr Dr Lie Li
Contact information
Public, Scientific, Principal Investigator
Mazzeh Highway
Damascus University
Damascus
0000
Syria
 ORCID ID |
0000-0002-3528-2779 |
|---|---|
| Phone | +963 (0)937371462 |
| fatimaelmi14@gmail.com |
Scientific
Mezzeh Highway
Damascus
0000
Syria
| ORCID ID |
0000-0002-2428-5499 |
|---|---|
| Phone | +963 (0)955873388 |
| bassel.brad@damascusuniversity.edu.sy |
Study information
| Study design | Multicenter interventional randomized clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Other, Quality of life, Treatment, Safety |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Comparison between the conventional surgical technique and implants manufactured by 3D printing regarding cleft lip rhinoplasty patients |
| Study objectives | Null hypothesis: The studied groups are equal, and there is no significant difference in nasal repair between the traditional surgical technique and implants manufactured by 3D printing in the research variables studied among cleft lip patients. Alternative hypothesis: The groups studied are not equal, and there is a significant difference in nasal repair between the traditional surgical technique and implants manufactured by 3D printing in the research variables studied among cleft lip patients. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | Approved 14/05/2024, the medical research committee at Damascus University faculty of dental medicine, +963 (0)944703131, +963 (0)940404840, +963 (0)966195484; abeer79.aljoujou@damascusuniversity.edu.sy, Mohammad.hajeer@damascusuniversity.edu.dy, khaldoun.darwich@damascusuniversity.edu.sy), ref: DN-290424-232 |
| Health condition(s) or problem(s) studied | Cleft lip |
| Intervention | Following sample enrollment and recruitment, the sample is randomly divided into two groups for this investigation via https://randomizer.org/. Patients in the control group will undergo rhinoplasty (open technique) and receive a costal cartilaginous graft. Patients in the experimental group will undergo rhinoplasty (open technique) and receive 3D-printed biocompatible silicone implants. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Symmetry measured using geometric morphometrics-based Holistic Facial Asymmetry Score (HFAS) at baseline, preoperative, 1 week and 4 months postoperatively 2. Pain following surgical intervention is measured using the visual analogue score (VAS) at baseline, 24, 48 and 72 hours |
| Secondary outcome measures | 1. Surgical operation time: the duration of each surgery will be calculated in minutes by subtracting the time of leaving the OR from the time of entering the OR. Based on the scheduled duration, the calculated durations were categorized as either overestimation or underestimation. Finally, each independent variable was categorized and coded for analysis (one timepoint - intraoperative). 2. Patient satisfaction measured using the Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) at three timepoints: baseline, 24 and 72 hours 3. Bioreceptivity – bioacceptance measured by examining the following: 3.1. Implant's biological function: by accurately assessing the implant's biological function, one can determine how well the implant interacts with the surrounding tissue. Measured at 1 week, 1 month and 3 months postoperatively. 3.2. Biodegradation analysis: entails assessing how a biological system interacts with the body by examining the processes of biodegradation and tissue integration. Measured at 1 week, 1 month and 3 months postoperatively. 3.3. Evaluation of swelling and inflammation: the degree of swelling and inflammation can be quantified as a measure of implant acceptability. Measured at 1 week, 1 month and 3 months postoperatively. 3.4. Cell distribution study: the distribution and kinds of cells surrounding and inside the implant can be examined to determine its biological acceptability. Measured at 1 week, 1 month and 3 months postoperatively. |
| Overall study start date | 30/01/2024 |
| Completion date | 14/04/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 45 Years |
| Sex | Male |
| Target number of participants | 18 |
| Total final enrolment | 20 |
| Key inclusion criteria | 1. Older than 17 years old 2. The patient must not have a history of syndrome or any atrophy in the middle third of the face affecting the nasal structures 4. The patient must not have had a previous nose repair operation 5. The lip closure process should be performed using similar techniques 6. There is no case of pregnancy if the patient is female 7. There is no maxillofacial pain in the target area 8. There is no compensation or metal instrument in the body that may interfere with the resonator's magnetic field |
| Key exclusion criteria | 1. Younger than 18 years old 2. The patient has a history of syndrome 3. There is atrophy in the middle third of the face, which affects the nasal structures 4. There is any compensator or metal instrument in the body that may interfere with the field of the PCI magnet resonator |
| Date of first enrolment | 20/05/2024 |
| Date of final enrolment | 20/02/2025 |
Locations
Countries of recruitment
- Syria
Study participating centre
Damascus
000
Syria
Sponsor information
University/education
Faculty of Dental Medicine
Oral and Maxillofacial Surgery Department
Mazzeh
Damascus
0000
Syria
| Phone | +963 (0)112232152 |
|---|---|
| damasuniv@net.sy | |
| Website | http://www.damascusuniversity.edu.sy |
"ROR" |
https://ror.org/03m098d13 |
Hospital/treatment centre
Department of Adult and Pediatric Oral, Maxillofacial Surgery and Facial Plastic Surgery
Neue Donnerschweer Str. 30
Oldenburg
26123
Germany
| Phone | +49 (0)4412489225 |
|---|---|
| kieferchirurgie@klinikum-oldenburg.de |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/02/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
17/06/2024: Study's existence confirmed by the medical research committee at Damascus University faculty of dental medicine.
