A comparison between traditional surgical technology and implant technology manufactured through 3D printing for nasal repair in patients with cleft lip

Not Applicable

• Conditions: Cleft lip; Genetic Diseases

• Registration Number: ISRCTN97129635
• Lead Sponsor: Damascus University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-21
• Last Update Posted: 8 July 2024
• Study Completion: 2025-04-14

Recruitment & Eligibility

• Status: Ongoing
• Sex: Male
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Symmetry measured using geometric morphometrics-based Holistic Facial Asymmetry Score (HFAS)<br>at baseline, preoperative, 1 week and 4 months postoperatively<br>2. Pain following surgical intervention is measured using the visual analogue score (VAS) at baseline, 24, 48 and 72 hours<br>