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

Not Applicable

Completed

• Conditions: Unilateral Cleft Lip

• Registration Number: NCT06637488
• Lead Sponsor: Mahmoud Akram

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-01
• Primary Completion: 2024-06-01
• Study Completion: 2024-09-01
• Status Verified: 2024-10
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-09
• Study First Posted: 2024-10-15
• Last Update Submitted: 2024-10-23
• Last Update Posted: 2024-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

1. Patients of both sexes with unilateral cleft lip.
2. Age range 10 - 24 weeks.
3. Hemoglobin more than 10 gm/dl .
4. Weight more than 10 lbs.

Exclusion Criteria

1. Syndromic patients.
2. Patients with conditions contradicting operation.
3. Patients with Bilateral cleft lip.
4. Patients with previous surgeries in lip and nose.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Nostril height	6 months	The greatest vertical distance of the nostril in millimeters .
Nostril width	6 months	This measure was defined as the greatest horizontal distance between the inner medial and lateral borders of the nostril aperture in millimeters.
Columellar Deviation Angle	6 months	The midline columellar deviation from the vertical reference line was measured in degrees.
Nasolabial Groove Angle	6 months	To assess the flare of the nasal alar base, the angle between a line tangential to the outer alar basepoint and the horizontal reference line was measured in degrees.

Trial Locations

Locations (1)

faculty of dentistry, Alexandria university; 🇪🇬 Alexandria, Egypt