Effectiveness of a Customized 3D Printed Nostril Retainer Combined With Taping Vs.Taping Only on Enhancing the Nasolabial Esthetics and Maxillary Arch Dimensions in Infants With Unilateral Complete Cleft Lip and Palate.

Not Applicable

Not yet recruiting

• Conditions: Cleft Lip and Palate
• Interventions: Device: Customized 3D printed nostril retainer combined with lip taping; Procedure: Lip taping

• Registration Number: NCT06211205
• Lead Sponsor: Cairo University

Brief Summary

Lip taping was proven as simple, handy technique of PSIO for alveolar molding yielding enhanced maxillary arch dimensions in UCCLP infants.

The approach behind this study is to combine this simple step with a digitally designed 3D printed customized nasal molding device to enhance the naslolabial esthetics and maxillary arch dimensions in infants with unilateral complete cleft lip and palate, employing full digital workflow.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-24
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18
• Study Start: 2024-01-30
• Primary Completion: 2024-12-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Infants with age range from 1-30 days.
2. Unilateral complete cleft lip and palate
3. Medically free subjects.
4. Both males and females.

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Exclusion Criteria

1. Patients older than 30 days.
2. Syndromic patients with other defects in addition to cleft lip and palate.
3. Patients with bilateral cleft lip and palate.
4. Incomplete cleft lip.
5. Patient with previous surgical lip repair or adhesion.
6. Patients with previous presurgical infant orthopedic treatment.
7. Medically compromised patients.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Customized nostril retainer combined with lip taping	Customized 3D printed nostril retainer combined with lip taping	-
Lip taping	Lip taping	-

Primary Outcome Measures

Name	Time	Method
Nasolabial esthetics	3 months	Nasal basal width, Collumella Length, Defetcted Nostril width and height, Interlabial gap will be measured in mm at 2 time points to evaluate the effect of the intervention.; This will be performed on a 3D scan for the infants and through calibrated photographs

Secondary Outcome Measures

Name	Time	Method
Maxillary arch changes	3 months	Interalveolar gap will be measured in mm through an intraoral scan for the infants at 2 time points

Trial Locations

Locations (1)

Department of Orthodontics, Faculty of Dentistry, Cairo university; 🇪🇬 Cairo, Egypt