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.

Cairo University (CU) logo

Cairo University (CU)

Status

Not yet enrolling

Conditions

Cleft Lip and Palate

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT06211205
NCT26091993123

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

Under 30 days old

Volunteers

Accepts Healthy Volunteers

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

  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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Customized nostril retainer combined with lip taping
Experimental group
Treatment:
Device: Customized 3D printed nostril retainer combined with lip taping
Lip taping
Active Comparator group
Treatment:
Procedure: Lip taping

Trial contacts and locations

1

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Central trial contact

Hana A Adawy

Data sourced from clinicaltrials.gov

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