Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

NCT ID: NCT06411444

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-15

Study Completion Date

2025-04-15

Brief Summary

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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

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Conditions

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Cleft Lip Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Kidney Shaped Nasal Stent

Conventional NAM with kidney shaped nasal stent added to it.

Group Type ACTIVE_COMPARATOR

Grape Design Nasal Stent

Intervention Type DEVICE

Grape Design Nasal Stent

Grape Design Nasal Stent

Conventional NAM with grape shaped nasal stent added to it.

Group Type EXPERIMENTAL

Grape Design Nasal Stent

Intervention Type DEVICE

Grape Design Nasal Stent

Interventions

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Grape Design Nasal Stent

Grape Design Nasal Stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Syndromic patients.
* older than 30 days old.
Minimum Eligible Age

0 Days

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abd El-Ghafour

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Cairo, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mohamed Abd-El-Ghafour, PhD

Role: CONTACT

01007433288

Facility Contacts

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Mohamed Abd-El-Ghafour, PhD

Role: primary

+2 01007433288

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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