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 )

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.

Study Overview

• Status: Completed
• Conditions: Unilateral Cleft Lip
• Intervention / Treatment: Procedure: cleft lip repair using fisher technique; Procedure: cleft lip repair using fisher technique

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21715
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Unilateral cleft lip repair using customized nasal conformer	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
Active Comparator: Unilateral cleft lip repair without using customized nasal conformer	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nostril height	The greatest vertical distance of the nostril in millimeters .	6 months
Nostril width	This measure was defined as the greatest horizontal distance between the inner medial and lateral borders of the nostril aperture in millimeters.	6 months
Columellar Deviation Angle	The midline columellar deviation from the vertical reference line was measured in degrees.	6 months
Nasolabial Groove Angle	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.	6 months

Collaborators and Investigators

• Sponsor: Mahmoud Akram

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2024
• Primary Completion (Actual): June 1, 2024
• Study Completion (Actual): September 1, 2024

Study Registration Dates

• First Submitted: October 1, 2024
• First Submitted That Met QC Criteria: October 9, 2024
• First Posted (Actual): October 15, 2024

Study Record Updates

• Last Update Posted (Actual): October 26, 2024
• Last Update Submitted That Met QC Criteria: October 23, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Lip Diseases; Mouth Abnormalities; Cleft Lip
• Other Study ID Numbers: Nasal conformer in cleft lip

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No