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NCT06411444 Clinical Trial

Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

Cleft Lip and Palate Clinical Trial

Official title:
Effectiveness of Kidney Shaped Versus Grape Design Nasal Stents in Conjunction With Nasoalveolar Molding Appliance on Nasolabial Esthetics in Infants With Complete Unilateral Cleft Lip and Palate: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06411444
Other study ID # 001
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 15, 2024
Est. completion date April 15, 2025

Study information
Verified date May 2024
Source Cairo University
Contact Mohamed Abd-El-Ghafour, PhD
Phone 01007433288
Email m.abdelghafour@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 28
Est. completion date April 15, 2025
Est. primary completion date April 15, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 0 Days to 30 Days
Eligibility Inclusion Criteria: - Complete unilateral cleft lip and palate. - younger than 30 day old Exclusion Criteria: - Syndromic patients. - older than 30 days old.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Grape Design Nasal Stent
Grape Design Nasal Stent

Locations
Country Name City State
Egypt Faculty of Dentistry Cairo

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nase and lip esthetics Measuring linear measurements on 2D photos. Photos are planned to be taken before starting the treatment and right after finishing it.
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