Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

Not Applicable

Not yet recruiting

• Conditions: Cleft Lip and Palate; Cleft Lip
• Interventions: Device: Grape Design Nasal Stent

• Registration Number: NCT06411444
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-04-28
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-09
• Last Update Submitted: 2024-05-09
• Study First Posted: 2024-05-13
• Last Update Posted: 2024-05-13
• Study Start: 2024-05-15
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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Exclusion Criteria

• Syndromic patients.
• older than 30 days old.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kidney Shaped Nasal Stent	Grape Design Nasal Stent	Conventional NAM with kidney shaped nasal stent added to it.
Grape Design Nasal Stent	Grape Design Nasal Stent	Conventional NAM with grape shaped nasal stent added to it.

Primary Outcome Measures

Name	Time	Method
Nase and lip esthetics	Photos are planned to be taken before starting the treatment and right after finishing it.	Measuring linear measurements on 2D photos.

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Egypt