Effectiveness of Nasal-alar Elevator Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate

Cleft Lip and Palate Clinical Trial

Official title:

Effectiveness of Nasal-alar Elevator (NE) Combined With Taping Vs. Taping Alone on Improving the Nose Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04331379
• Other study ID #: 111
• Status: Completed
• Phase: N/A
• Start date: July 9, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized trial is designed to assess the effectiveness of nasal elevator as a presurgical infant orthopedics on improvement of nose esthetics vs taping alone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 30 Days

Eligibility

Inclusion Criteria:

• Infants with age range from 1-30 days.
• Unilateral complete cleft lip and alveolus.
• Medically free subjects.
• Both males and females.
• Cleft gap more than 10 mm.

Exclusion Criteria:

• 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.
• Cleft gap distance less than 10mm

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Device:
• Nasal Elevator
A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.
• Taping Alone
Horizontal tape alone.

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal Esthetics	Nasal esthetics will be following Dr Farkas' measurements and it will be carried out as linear and angular measurements on standardized photographs. it will be measured using photoshop software.	3 months
Primary	Maxillary arch changes	Different maxillary arch dimensions (e.g. cleft and arch widths and symmetry) will be measured virtually on digital models in mm using 3shape software.	3 months