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

NCT06637488 | Completed DMC

• 1 other identifier: Nasal conformer in cleft lip
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Cleft Lip

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Unilateral cleft lip repair using customized nasal conformer

EXPERIMENTAL

Procedure: cleft lip repair using fisher technique

Unilateral cleft lip repair without using customized nasal conformer

ACTIVE COMPARATOR

Procedure: cleft lip repair using fisher technique

Interventions

cleft lip repair using fisher technique PROCEDURE

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

Unilateral cleft lip repair using customized nasal conformer

Eligibility Criteria

• Age: 10 Weeks - 24 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Syndromic patients.
• Patients with conditions contradicting operation.
• Patients with Bilateral cleft lip.
• Patients with previous surgeries in lip and nose.

Sponsors & Collaborators

• Mahmoud Akram: lead

Study Sites (1)

faculty of dentistry, Alexandria university

Alexandria, 21715, Egypt

Location

Related Publications (1)

• Khodir MA, Osman SM, Ragab HR, AboulHassan MA, Oraby MS. Assessment of symmetry and parental satisfaction after use of customized nasal conformers in unilateral cleft lip repair: a randomized controlled clinical trial. Head Face Med. 2025 Aug 1;21(1):55. doi: 10.1186/s13005-025-00533-6.

  PMID: 40751267 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant lecturer of Oral and Maxillofacial surgery

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 15, 2024
• Study Start: January 1, 2024
• Primary Completion: June 1, 2024
• Study Completion: September 1, 2024
• Last Updated: October 26, 2024

Record last verified: 2024-10

Locations

EG (1)