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

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 1

Conditions: Cleft Lip and Cleft Palate

Treatments: 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

Study type: Interventional

Funder types: Other

Identifiers

NCT06589453

D-NAM 2024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Nasal stent with Digital Nasoalveolar molding

Active Comparator group

Treatment:

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

Nasal elevator with Digital Nasoalveolar molding

Experimental group

Description:

Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants.

Treatment:

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