Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

May 9, 2024 updated by: Mohamed Abd El-Ghafour, Cairo University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Syndromic patients.
  • older than 30 days old.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Kidney Shaped Nasal Stent
Conventional NAM with kidney shaped nasal stent added to it.
Device: Grape Design Nasal Stent
Grape Design Nasal Stent
Experimental: Grape Design Nasal Stent
Conventional NAM with grape shaped nasal stent added to it.
Device: Grape Design Nasal Stent
Grape Design Nasal Stent

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2024

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

April 15, 2025

Study Registration Dates

First Submitted

April 28, 2024

First Submitted That Met QC Criteria

May 9, 2024

First Posted (Actual)

May 13, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2024

Last Update Submitted That Met QC Criteria

May 9, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 001 (NavyGHB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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