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

Al-Azhar University

Status: Not yet enrolling

Conditions: Nasoalveolar Molding; Unilateral Cleft Lip

Treatments: Device: Naso Alveolar Mold; Device: Taping with nasal elevator:

Study type: Interventional

Funder types: Other

Identifiers

NCT05940389

Innovinity Medical Hub

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Infants with 0 (after birth) to 1 month of age
• Non-syndromic with no other medical conditions
• Unilateral complete cleft lip and palate
• Cleft width > 5 mm

Exclusion criteria

• Syndromic UCLP or bilateral cleft lip and palate
• Incomplete UCLP
• Cleft width ≤ 5 mm

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

24 participants in 2 patient groups

NAM appliance Group

Experimental group

Description:

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. The surgical lip repair technique involved will be done by one surgeon using the Delare technique without the blind dissection of the alar cartilage.

Treatment:

Device: Naso Alveolar Mold

Taping with nasal elevator:

Experimental group

Description:

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. The surgical lip repair technique involved will be done by one surgeon using the Delare technique without the blind dissection of the alar cartilage.

Treatment:

Device: Taping with nasal elevator: