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

NCT ID: NCT04331379

Last Updated: 2022-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-09

Study Completion Date

2021-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cleft Lip and Palate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Nasal Elevator

Group Type EXPERIMENTAL

Nasal Elevator

Intervention Type DEVICE

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

Taping Alone

Group Type ACTIVE_COMPARATOR

Taping Alone

Intervention Type DEVICE

Horizontal tape alone.

Interventions

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Nasal Elevator

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

Intervention Type DEVICE

Taping Alone

Horizontal tape alone.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Day

Maximum Eligible Age

30 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Abd El-Ghafour

Lecturer of Orthodontics

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Faculty of Dentistry

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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111

Identifier Type: -

Identifier Source: org_study_id

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