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

Mahmoud Akram

Status: Completed

Conditions: Unilateral Cleft Lip

Treatments: Procedure: cleft lip repair using fisher technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06637488

Nasal conformer in cleft lip

Details and patient eligibility

About

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.

Enrollment: 14 patients

Sex: All

Ages: 10 to 24 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

Unilateral cleft lip repair using customized nasal conformer

Experimental group

Treatment:

Procedure: cleft lip repair using fisher technique

Procedure: cleft lip repair using fisher technique

Unilateral cleft lip repair without using customized nasal conformer

Active Comparator group

Treatment:

Procedure: cleft lip repair using fisher technique

Procedure: cleft lip repair using fisher technique