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Not yet recruitingNCT06411444Updated May 13, 2024

Effect of Different Nasal Stent Designs With Nasoalveolar Molding Appliance

An interventional study of Grape Design Nasal Stent in Cleft Lip and Cleft Lip and Palate, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged 0 Days to 30 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-13.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 6 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
0 Days to 30 Days
Sex
All
01

Study 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.

02

Conditions studied

  • Cleft Lip
  • Cleft Lip and Palate

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03

In context

Cleft Lip

168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.

This study's planned enrollment of 28 is close to the median of 30 across 116 interventional studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Browse Cairo University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Days to 30 Days
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Syndromic patients.
  • older than 30 days old.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
28 participants (estimated)

Study arms

  • Active comparator
    Kidney Shaped Nasal Stent

    Conventional NAM with kidney shaped nasal stent added to it.

    Device: Grape Design Nasal Stent

  • Experimental
    Grape Design Nasal Stent

    Conventional NAM with grape shaped nasal stent added to it.

    Device: Grape Design Nasal Stent

Interventions

  • DeviceGrape Design Nasal Stent

    Grape Design Nasal Stent

06

What researchers measure

Primary outcomes

  1. Nase and lip esthetics

    Measuring linear measurements on 2D photos.

    Time frame: Photos are planned to be taken before starting the treatment and right after finishing it.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for May 2024; primary completion for Apr 2025, 11 months later.

Of 64 non-industry interventional studies with no phase under Cleft Lip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 33. This study's planned 11 months is below that.

Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 15 and three quarters within 33.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2024
First posted
May 13, 2024
StartEst.
May 15, 2024
Primary completionEst.
Apr 15, 2025
CompletionEst.
Apr 15, 2025
Last update
May 13, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06411444
Lead sponsor
Cairo University
Responsible party
Mohamed Abd El-Ghafour (Lecturer, Cairo University) — Principal investigator
First posted
May 13, 2024
Start date
May 15, 2024 (estimated)
Primary completion
Apr 15, 2025 (estimated)
Completion
Apr 15, 2025 (estimated)
Last update
May 13, 2024

Study contacts

Mohamed Abd-El-Ghafour, PhD
Contact
m.abdelghafour@dentistry.cu.edu.eg
01007433288

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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