Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair (a Randomized Controlled Clinical Trial )
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unilateral Cleft Lip
- Sponsor
- Mahmoud Akram
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Nasolabial Groove Angle
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Mahmoud Akram
Assistant lecturer of Oral and Maxillofacial surgery
Alexandria University
Eligibility Criteria
Inclusion Criteria
- •Patients of both sexes with unilateral cleft lip.
- •Age range 10 - 24 weeks.
- •Hemoglobin more than 10 gm/dl .
- •Weight more than 10 lbs.
Exclusion Criteria
- •Syndromic patients.
- •Patients with conditions contradicting operation.
- •Patients with Bilateral cleft lip.
- •Patients with previous surgeries in lip and nose.
Outcomes
Primary Outcomes
Nasolabial Groove Angle
Time Frame: 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.
Nostril height
Time Frame: 6 months
The greatest vertical distance of the nostril in millimeters .
Nostril width
Time Frame: 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
Time Frame: 6 months
The midline columellar deviation from the vertical reference line was measured in degrees.