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

Cairo University32 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cleft Lip and Palate

Interventions

Nasal ElevatorDEVICE

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

Taping AloneDEVICE

Horizontal tape alone.

Eligibility

Sex: ALLMin age: 1 DayMax age: 30 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Faculty of Dentistry

Giza, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 3 months

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.

Time frame: 3 months

Data from ClinicalTrials.gov

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