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.

NCT06211205 | Unknown

• 1 other identifier: NCT26091993123
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cleft Lip and Palate

Outcome Measures

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

  3 months

Secondary Outcomes (1)

• Maxillary arch changes

  3 months

Study Arms (2)

Customized nostril retainer combined with lip taping

EXPERIMENTAL

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

Lip taping

ACTIVE COMPARATOR

Procedure: Lip taping

Interventions

Customized 3D printed nostril retainer combined with lip taping DEVICE

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

Customized nostril retainer combined with lip taping

Lip taping PROCEDURE

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

Lip taping

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Patients older than 30 days.
• Syndromic patients with other defects in addition to cleft lip and palate.
• Patients with bilateral cleft lip and palate.
• Incomplete cleft lip.
• Patient with previous surgical lip repair or adhesion.
• Patients with previous presurgical infant orthopedic treatment.
• Medically compromised patients.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, Cairo university

Cairo, Egypt

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Hana A Adawy

CONTACT

+201002061202; hana_adel@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: Hana Adawy, Principal Investigator

Study Record Dates

• First Submitted: December 24, 2023
• First Posted: January 18, 2024
• Study Start: January 30, 2024
• Primary Completion: December 30, 2024
• Study Completion: June 30, 2025
• Last Updated: January 18, 2024

Record last verified: 2024-01

Locations

EG (1)