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.

Cleft Lip and Palate Clinical Trial

Official title:

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: A Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06211205
• Other study ID #: NCT26091993123
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 30, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: Cairo University
• Contact: Hana A Adawy
• Phone: +201002061202
• Email: hana_adel[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Device:
• Customized 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

Procedure:
• Lip taping
the infants will receive lip tape to approximate the labial and alveolar segments

Locations

Country	Name	City	State
Egypt	Department of Orthodontics, Faculty of Dentistry, Cairo university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maxillary arch changes	Interalveolar gap will be measured in mm through an intraoral scan for the infants at 2 time points	3 months