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

Unilateral Cleft Lip Clinical Trial

Official title: Nasolabial Soft Tissue Esthetics and Maxillary Changes in Unilateral Cleft Lip and Palate Using PreSurgical Infant Orthopedics With Different Approaches: A Parallel-arm Randomized Clinical Trial

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

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. The cleft width along with the nasal deformity and collapse in the nasal cartilage could affect the outcome of the surgical lip closure with the cleft width as a major factor affecting the tension produced in the closure and future collapse of the nose. There is a striking diversity in the literature regarding treatment protocols for UCLP, with no standardized management protocols . Clinical decision-making based on evidence is lacking due to the few randomized clinical trials comparing the effectiveness of different approaches. A recent systematic review conducted a comprehensive search aiming at identifying the different treatment protocols and effectiveness of using pre-surgical infant orthopedics (PSIO) and recommended the need for further well-designed and high-quality randomized clinical trials (RCTs) in this area due to the unstandardized protocols with high diversity. Various studies supported the positive effect of naso-alveolar molding (NAM) appliance therapy on nasal symmetry in UCLP treatment. The NAM therapy decreases the severity of the initial cleft deformity and repositions deformed nasal cartilage and alveolar process, which has many beneficial results in the surgery outcome. Taping has been assessed in infants with UCLP and was deemed successful as well by a few studies. To our knowledge, no RCTs are comparing the use of NAM therapy to taping with the use of nasal elevators on UCLP patients. ;

Related Conditions & MeSH terms

• Cleft Lip
• Unilateral Cleft Lip

• NCT number: NCT05940389
• Study type: Interventional
• Source: Al-Azhar University
• Contact: Abdallah Bahaa, M.Sc.
• Phone: 01114084090
• Email: abdallahbahaa000@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2023
• Completion date: April 1, 2025