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

NCT ID: NCT06637488

Last Updated: 2024-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2024-09-01

Brief Summary

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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

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Conditions

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Unilateral Cleft Lip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Unilateral cleft lip repair using customized nasal conformer

Group Type EXPERIMENTAL

cleft lip repair using fisher technique

Intervention Type 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 without using customized nasal conformer

Group Type ACTIVE_COMPARATOR

cleft lip repair using fisher technique

Intervention Type 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. No nasal conformers used in this group

Interventions

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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

Intervention Type 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

10 Weeks

Maximum Eligible Age

24 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahmoud Akram

OTHER

Sponsor Role lead

Responsible Party

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Mahmoud Akram

Assistant lecturer of Oral and Maxillofacial surgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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faculty of dentistry, Alexandria university

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type DERIVED
PMID: 40751267 (View on PubMed)

Other Identifiers

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Nasal conformer in cleft lip

Identifier Type: -

Identifier Source: org_study_id

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