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

NCT06589453 — Phase 1, Unknown, 20 participants, Cairo University

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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

Registry	NCT06589453, acronym D-NAM
Status	Unknown
Phase	Phase 1
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	20 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Cleft Lip and Cleft Palate
Interventions	Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants, Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants (Device)
Dates	start 2024-11-01 (estimated), primary completion 2026-03-30 (estimated), completion 2026-10-01 (estimated), first posted 2024-09-19, last updated 2024-10-17

-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 evaluate their effect on the nasolabial esthetics.

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+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 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.

+Arms and interventions

Arm	Type	Interventions	Description
Nasal stent with Digital Nasoalveolar molding	Active comparator	Device: Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants
Nasal elevator with Digital Nasoalveolar molding	Experimental	Device: Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants	Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants.

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

+Outcome measures

Primary outcomes

Nasolabial esthetics [4-6 months]: Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.

Secondary outcomes

Maxillary arch changes [4-6 months]: Maxillary arch changes will be assessed in millimeters using maxillary digital models.

+Eligibility

Sex: All, ages: 1 Day to 1 Month

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.