NCT06411444

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

May 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2025

Completed
Last Updated

May 13, 2024

Status Verified

May 1, 2024

Enrollment Period

11 months

First QC Date

April 28, 2024

Last Update Submit

May 9, 2024

Conditions

Cleft LipCleft Lip and Palate

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Kidney Shaped Nasal Stent

ACTIVE COMPARATOR

Conventional NAM with kidney shaped nasal stent added to it.

Device: Grape Design Nasal Stent

Grape Design Nasal Stent

EXPERIMENTAL

Conventional NAM with grape shaped nasal stent added to it.

Device: Grape Design Nasal Stent

Interventions

Grape Design Nasal StentDEVICE

Grape Design Nasal Stent

Grape Design Nasal StentKidney Shaped Nasal Stent

Eligibility Criteria

Age0 Days - 30 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Syndromic patients.
  • older than 30 days old.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry

Cairo, 00202, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Mohamed Abd-El-Ghafour, PhD

CONTACT

01007433288m.abdelghafour@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

April 28, 2024

First Posted

May 13, 2024

Study Start

May 15, 2024

Primary Completion

April 15, 2025

Study Completion

April 15, 2025

Last Updated

May 13, 2024

Record last verified: 2024-05

Locations

EG(1)