Evaluation of Nasal Elevator Versus Grayson's Nasal Stent with D-NAM Appliance on Nasolabial Esthetics in Bilateral Cleft Lip and Palate Infants (D-NAM)

October 16, 2024 updated by: : Donia Ayman Ahmed Ezzeldin ElSayed, Cairo University

Evaluation of Nasal Elevator Versus Grayson's Nasal Stent in Conjunction with Digital Nasoalveolar Molding (D-NAM) Appliance on Nasolabial Esthetics in Infants with Bilateral Cleft Lip and Palate: a Randomized Clinical Trial

Newborns with bilateral cleft lip/ palate will be treated pre-surgically by either nasal elevator or Grayson nasal stent in conjunction with digital nasoalveolar molding (D-NAM) appliance in order to evaluate their effect on the nasolabial esthetics.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of this trial is to evaluate and compare the short-term effect of nasal elevator with Grayson nasal stent in conjunction with digital nasoalveolar molding appliances at 2 stages T1 (Before NAM therapy), and T2 (After NAM therapy) as regards nasolabial esthetics and maxillary arch changes.

Newborns with Bilateral cleft lip/ palate will be allocated randomly into two groups: the first group will receive nasal elevator with digital nasoalveolar molding appliance while the second group will receive Grayson nasal stent with digital nasoalveolar molding appliance. The follow-up period will be 4-6 months till surgical lip closure. The nasolabial esthetics will be assessed using facial scans and 2D photographs, while changes in the maxillary arch will be assessed by digital maxillary models.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 1

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 Contact Backup

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

No

Description

Inclusion Criteria:

  • Non-syndromic Infants with complete BCLP infants
  • Infants less than 1 month of age.
  • Males and females.
  • Infants with displaced premaxilla
  • Patients whose parents provided written consent for the study.

Exclusion Criteria:

  • Patients above 1 month of age.
  • Syndromic and systemically ill infants.
  • Patients with unilateral cleft lip and palate.
  • Incomplete Cleft lip or Simonart band (soft tissue bridge at the cleft side).
  • Medically compromised patients
  • Patien parents/guardians who will be unwilling to go through the Naso-alveolar molding (NAM) therapy.

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: Nasal stent with Digital Nasoalveolar molding
Device: Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants
Nasal stent that is used in conjunction with digital nasoalveolar molding in bilateral cleft lip and palate infants
Experimental: Nasal elevator with Digital Nasoalveolar molding
Nasal elevator will be used in conjunction with digital nasoalveolar molding appliance to improve nasolabial esthetics in bilateral cleft lip and palate infants.
Device: Nasal elevator with digital nasoalveolar molding in bilateral cleft lip and palate infants
This is a unique nasal elevator aiming to improve nasolabial esthetics in conjunction with digital nasoalveolar molding appliance when used in bilateral cleft lip and palate infants.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nasolabial esthetics
Time Frame: 4-6 months
Columellar length is to be measured in millimeters digitally using facial scans before and after Nasoalveolar Molding therapy.
4-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maxillary arch changes
Time Frame: 4-6 months
Maxillary arch changes will be assessed in millimeters using maxillary digital models.
4-6 months

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)

November 1, 2024

Primary Completion (Estimated)

March 30, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 9, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

October 17, 2024

Last Update Submitted That Met QC Criteria

October 16, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-NAM 2024

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

product manufactured in and exported from the U.S.

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.

Clinical Trials on Cleft Lip and Cleft Palate

Clinical Trials on Nasal stent with digital nasoalveolar molding in bilateral cleft lip and palate infants

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kuwait

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe