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)

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

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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