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Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches

NCT05940389 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2023-07-11

No results posted yet for this study

Summary

The nasal deformity is an abnormality in the appearance and structure of the nose in cleft patients having unilateral cleft lip and palate (UCLP). It involves the displacement of the lower lateral nasal cartilage, oblique and short columella, depressed dome, overhanging nostril apex, and deviated septum. Difficulty in breathing and smelling are the main problems of this deformity. Rhinoplasty for CLP patients is very complicated due to the complex nature of this type of deformity, especially in wide and bilateral cleft patients it is quite challenging.

Conditions

  • Unilateral Cleft Lip
  • Nasoalveolar Molding

Interventions

DEVICE

Naso Alveolar Mold

The NAM appliance is constructed according to the Grayson technique \[8\] with the nasal stent added from the start. The adhesive paste is used to hold the alveolar plate in place and labial taping is used. Patients are followed each 2 to 3 weeks for the appliance to be relined and selectively ground to modify the pressure as needed.

DEVICE

Taping with nasal elevator:

For the lip approximation, Airoplast tape is used which is water resistant transparent and coated with hypoallergic adhesive on one side. The nasal elevator is 3D printed from the design inspired by the Dynacleft nasal elevator. Patients will be followed each 2 to 3 weeks for any modifications or adjustments.

Sponsors & Collaborators

  • Innovinity medical hub

    collaborator UNKNOWN

  • Smile train

    collaborator UNKNOWN

  • Al-Azhar University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-01
Primary Completion
2025-03-01
Completion
2025-04-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05940389 on ClinicalTrials.gov