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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT04331379

Collaborator

(none)

Enrollment

Location

Arms

17.7

Actual Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cleft Lip and Palate	Device: Nasal Elevator Device: Taping Alone	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

32 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 9, 2020

Actual Primary Completion Date :

Dec 30, 2021

Actual Study Completion Date :

Dec 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Nasal Elevator	Device: Nasal Elevator A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.
Active Comparator: Taping Alone	Device: Taping Alone Horizontal tape alone.

Arm

Intervention/Treatment

Experimental: Nasal Elevator

Device: Nasal Elevator

A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.

Active Comparator: Taping Alone

Device: Taping Alone

Horizontal tape alone.

Outcome Measures

Primary Outcome Measures

Nasal Esthetics [3 months]
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.
Maxillary arch changes [3 months]
Different maxillary arch dimensions (e.g. cleft and arch widths and symmetry) will be measured virtually on digital models in mm using 3shape software.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 30 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry	Giza		Egypt	00202

Sponsors and Collaborators

Cairo University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Abd El-Ghafour, Lecturer of Orthodontics, Cairo University

ClinicalTrials.gov Identifier:

NCT04331379

Other Study ID Numbers:

First Posted:

Apr 2, 2020

Last Update Posted:

Mar 10, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cleft Lip

Study Results

No Results Posted as of Mar 10, 2022