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Completed

NCT Number: NCT06637488

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

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.

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Key information

Conditions

Unilateral Cleft Lip

Age range

10 week–24 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of dentistry, Alexandria university

Alexandria, 21715, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Nostril height

    Time frame: 6 months

    The greatest vertical distance of the nostril in millimeters .

  2. 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.

  3. Columellar Deviation Angle

    Time frame: 6 months

    The midline columellar deviation from the vertical reference line was measured in degrees.

  4. 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.

Sponsors and collaborators

Lead sponsor

Mahmoud Akram

Other

Registry information

Official study title

Correction of Cleft Nasal Deformity Using Customized Milled Nasal Conformer in Unilateral Cleft Lip Repair (a Randomized Controlled Clinical Trial )

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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