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

Not Applicable

Completed

• Conditions: Cleft Lip and Palate
• Interventions: Device: Nasal Elevator; Device: Taping Alone

• Registration Number: NCT04331379
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-30
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-02
• Study Start: 2020-07-09
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal Elevator	Nasal Elevator	-
Taping Alone	Taping Alone	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Giza, Egypt