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

Phase 1

Not yet recruiting

• Conditions: Cleft Lip and Cleft Palate
• Interventions: Device: Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants; Device: Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants

• Registration Number: NCT06589453
• Lead Sponsor: Cairo University

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 evaluate their effect on the nasolabial esthetics.

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.

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-02
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-17
• Study Start: 2024-11-01
• Primary Completion: 2026-03-30
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal stent with Digital Nasoalveolar molding	Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants	-
Nasal elevator with Digital Nasoalveolar molding	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Maxillary arch changes	4-6 months	Maxillary arch changes will be assessed in millimeters using maxillary digital models.