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 University (CU)

Status: Completed

Conditions: Cleft Lip and Palate

Treatments: Device: Taping Alone; Device: Nasal Elevator

Study type: Interventional

Funder types: Other

Identifiers

NCT04331379

111

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 1 to 30 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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32 participants in 2 patient groups

Nasal Elevator

Experimental group

Treatment:

Device: Nasal Elevator

Taping Alone

Active Comparator group

Treatment:

Device: Taping Alone