Cleft lip Genetic Diseases
Conditions
Interventions
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 (
Sponsors
Damascus University
University Hospital Oldenburg
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Syria
Contacts
Public ContactFatima Elmi
Outcome results
None listed