NCT06637488

Using Customized Nasal Conformer in Correction of Cleft Nasal Deformity in Patients with Unilateral Cleft Lip

Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair (a Randomized Controlled Clinical Trial )

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Mahmoud Akram · Academic / Other
• Sex: All
• Age: 10 Weeks – 24 Weeks
• Healthy volunteers: Not accepted

Summary

The goal of the study is to compare the cleft lip repair with and without the usage of customized milled nasal conformers in unilateral cleft lip patients on nostril size , alar cartilage and proportion of symmetry to the normal side . * Comparing anthropometric measurements similarity between cleft and normal sides such as; nostril width and height , columellar deviation and nasolabial angle. * Evaluation of degree of similarity using esthetic scales at six months postoperative. Participants will receive nasal conformers intraoperative with follow up of 6 months.

Conditions

• Unilateral Cleft Lip

Interventions

Type	Name	Description
PROCEDURE	cleft lip repair using fisher technique	Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. suturing the nasal conformer in the cleft side
PROCEDURE	cleft lip repair using fisher technique	Disinfection of the field using Betadine , marking for the incision lines on the lip and vermilion on skin and mucosa , doing incisions as described by Fisher sub anatomic unit repair in 2005 , suturing using vicryl and prolene sutures. No nasal conformers used in this group

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-06-01
• Completion: 2024-09-01
• First posted: 2024-10-15
• Last updated: 2024-10-26

Locations

1 site across 1 country: Egypt