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Not yet recruitingNCT06211205Updated Jan 18, 2024

Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.

An interventional study of Customized 3D printed nostril retainer combined with lip taping and Lip taping in Cleft Lip and Palate, sponsored by Cairo University. Not yet recruiting at 1 site in Egypt. Open to participants aged Up to 30 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-18.

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

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
Up to 30 Days
Sex
All
01

Study summary

Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.

The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.

02

Conditions studied

  • 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 30 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.

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

04

Who can participate

Ages eligible
Up 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

  1. Infants with age range from 1-30 days.
  2. Unilateral complete cleft lip and palate
  3. Medically free subjects.
  4. Both males and females.

Exclusion criteria

Exclusion Criteria:

  1. Patients older than 30 days.
  2. Syndromic patients with other defects in addition to cleft lip and palate.
  3. Patients with bilateral cleft lip and palate.
  4. Incomplete cleft lip.
  5. Patient with previous surgical lip repair or adhesion.
  6. Patients with previous presurgical infant orthopedic treatment.
  7. Medically compromised patients.
05

Study design

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

Study arms

  • Experimental
    Customized nostril retainer combined with lip taping

    Device: Customized 3D printed nostril retainer combined with lip taping

  • Active comparator
    Lip taping

    Procedure: Lip taping

Interventions

  • DeviceCustomized 3D printed nostril retainer combined with lip taping

    the infants will receive a customised nostril retainer appliance to enhance the nasal esthetics combined with lip tape to approximate the labial and alveolar segments

  • ProcedureLip taping

    the infants will receive lip tape to approximate the labial and alveolar segments

06

What researchers measure

Primary outcomes

  1. Nasolabial esthetics

    Nasal basal width, Collumella Length, Defetcted Nostril width and height, Interlabial gap will be measured in mm at 2 time points to evaluate the effect of the intervention. This will be performed on a 3D scan for the infants and through calibrated photographs

    Time frame: 3 months

Secondary outcomes

  1. Maxillary arch changes

    Interalveolar gap will be measured in mm through an intraoral scan for the infants at 2 time points

    Time frame: 3 months

07

Study locations

1 site
  • Department of Orthodontics, Faculty of Dentistry, Cairo university
    Cairo, Egypt
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06211205
Lead sponsor
Cairo University
Responsible party
Hana Adel Adawy (Hana Adawy, Principal Investigator, Cairo University) — Principal investigator
First posted
Jan 18, 2024
Start date
Jan 30, 2024 (estimated)
Primary completion
Dec 30, 2024 (estimated)
Completion
Jun 30, 2025 (estimated)
Last update
Jan 18, 2024

Study contacts

Hana A Adawy
Contact
hana_adel@dentistry.cu.edu.eg
+201002061202

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 Jan 2024. You cannot join it, but the record below documents what was studied.

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