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NCT Number: NCT06589453

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

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 evaluate their effect on the nasolabial esthetics.

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Key information

About this study

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 therapy), and T2 (After NAM therapy) as regards nasolabial esthetics and maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive Grayson nasal stent with digital nasoalveolar molding appliance. The follow-up period will be 4-6 months till surgical lip closure. The nasolabial esthetics will be assessed using facial scans and 2D photographs, while changes in the maxillary arch will be assessed by digital maxillary models.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants

Device

This is a unique nasal elevator aiming to improve nasolabial esthetics in conjunction with digital nasoalveolar molding appliance when used in bilateral cleft lip and palate infants.

Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants

Device

Nasal stent that is used in conjunction with digital nasoalveolar molding in bilateral cleft lip and palate infants

Primary outcomes

  1. Nasolabial esthetics

    Time frame: 4-6 months

    Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.

Secondary outcomes

  1. Maxillary arch changes

    Time frame: 4-6 months

    Maxillary arch changes will be assessed in millimeters using maxillary digital models.

Study contacts

Contact information is provided by the study sponsor or research team.

Donia Ayman Ahmed Ezzeldin, PhD

CONTACT

[email protected]

00201001200089

Mohamed Abd-El-Ghafour Omar

CONTACT

[email protected]

00201007433288

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

Evaluation of Nasal Elevator Versus Grayson's Nasal Stent in Conjunction with Digital Nasoalveolar Molding (D-NAM) Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate: a Randomized Clinical Trial

Acronym: D-NAM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Oct 17, 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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