Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

Cairo University (CU)

Status: Not yet enrolling

Conditions: Cleft Lip; Cleft Lip and Palate

Treatments: Device: Grape Design Nasal Stent

Study type: Interventional

Funder types: Other

Identifiers

NCT06411444

001

Details and patient eligibility

About

This study is designed to compare 2 different designs of nasal stents in conjunction with nasoalveolar molding appliance regarding the changes in nose and lip esthetics in infants with cleft lip and palate.

Enrollment: 28 estimated patients

Sex: All

Ages: Under 30 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Complete unilateral cleft lip and palate.
• younger than 30 day old

Exclusion criteria

• Syndromic patients.
• older than 30 days old.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 2 patient groups

Kidney Shaped Nasal Stent

Active Comparator group

Description:

Conventional NAM with kidney shaped nasal stent added to it.

Treatment:

Device: Grape Design Nasal Stent

Grape Design Nasal Stent

Experimental group

Description:

Conventional NAM with grape shaped nasal stent added to it.

Treatment:

Device: Grape Design Nasal Stent