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Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06411444
Enrollment
28
Registered
2024-05-13
Start date
2024-05-15
Completion date
2025-04-15
Last updated
2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleft Lip, Cleft Lip and Palate

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.

Interventions

DEVICEGrape Design Nasal Stent

Grape Design Nasal Stent

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
0 Days to 30 Days
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* Syndromic patients. * older than 30 days old.

Design outcomes

Primary

MeasureTime frameDescription
Nase and lip estheticsPhotos are planned to be taken before starting the treatment and right after finishing it.Measuring linear measurements on 2D photos.

Countries

Egypt

Contacts

Primary ContactMohamed Abd-El-Ghafour, PhD
m.abdelghafour@dentistry.cu.edu.eg01007433288

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026