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NCT06637488

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

Completed NA Last updated 26 October 2024
What this trial tests

NA trial testing cleft lip repair using fisher technique in Unilateral Cleft Lip in 14 participants. Completed in 1 September 2024.

Timeline
1 January 2024
Primary endpoint
1 June 2024
1 September 2024

Quick facts

Lead sponsorMahmoud Akram
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment14
Start date1 January 2024
Primary completion1 June 2024
Estimated completion1 September 2024
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Mahmoud Akram

Who can join

Adults 10 Weeks to 24 Weeks, any sex, with Unilateral Cleft Lip. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Digital fabrication of customized nasal conformers for unilateral cleft lip repair: a pilot randomized controlled trial.
    Khodir MA, Osman SM, Ragab HR, AboulHassan MA, et al · · 2026 · PMID 41987134 · DOI 10.1186/s12903-026-08274-x
  2. Assessment of symmetry and parental satisfaction after use of customized nasal conformers in unilateral cleft lip repair: a randomized controlled clinical trial.
    Khodir MA, Osman SM, Ragab HR, AboulHassan MA, et al · · 2025 · PMID 40751267 · DOI 10.1186/s13005-025-00533-6

Verify or expand the search:

Other recruiting trials for Unilateral Cleft Lip

Currently open trials in the same condition.

Other Mahmoud Akram trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06637488.

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