Status:

NOT_YET_RECRUITING

Evaluation of Nasal Elevator Versus Grayson's Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants

Lead Sponsor:

Cairo University

Conditions:

Cleft Lip and Cleft Palate

Eligibility:

All Genders

1-1 years

Phase:

PHASE1

Brief Summary

Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to ...

Detailed Description

The aim of this trial is to evaluate and compare the short-term effect of nasal elevator with Grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages T1 (Before NAM...

Eligibility Criteria

Inclusion

  • Non-syndromic Infants with complete BCLP infants
  • Infants less than 1 month of age.
  • Males and females.
  • Infants with displaced premaxilla
  • Patients whose parents provided written consent for the study.

Exclusion

  • Patients above 1 month of age.
  • Syndromic and systemically ill infants.
  • Patients with unilateral cleft lip and palate.
  • Incomplete Cleft lip or Simonart band (soft tissue bridge at the cleft side).
  • Medically compromised patients
  • Patien parents/guardians who will be unwilling to go through the Naso-alveolar molding (NAM) therapy.

Key Trial Info

Start Date :

November 1 2024

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

October 1 2026

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT06589453

Start Date

November 1 2024

End Date

October 1 2026

Last Update

October 17 2024

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