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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Unilateral Cleft Lip, Nasoalveolar Molding

Intervention / Treatment
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* Device: Naso Alveolar Mold
* Device: Taping with nasal elevator:


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Day
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized clinical trial, parallel arm, superiority framework with 1:1 allocation ratio.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NAM appliance Group<br>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. | Device: Naso Alveolar Mold<br>* 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.<br>* Other names: NAM;|
| Experimental: Taping with nasal elevator:<br>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. | Device: Taping with nasal elevator:<br>* 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.<br>* Other names: DYNA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nasal tip projection | Observing the change in the nasolabial angle by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| change in Columella height | observing the change in the linear distance (mm) from the subnasal point to the labral superiors point by the superimposition of the 3D facial scans at different time points (T0, T1, T2,T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in projection alar length | Observing the change in the linear distance (mm) from the most anterior point of the affected nasal ala to the deepest point at the base of the nose by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in width of the nostril | Observing the change in the linear distance (mm) from the most lateral point of the affected nasal ala to the most medial point of the affected ala by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in nasal basal width | Observing the change in the linear distance (mm) from the most lateral point of the affected nasal ala to the most medial point of the affected ala at the level of the nasal base by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in the angle of the columella | Observing the change in the columella-labial angle by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in cleft lip segment | Observing the change in the width (mm) of the labial cleft segment from the most lateral point to the most medial point at the widest area of the labial cleft by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in the height of the non-cleft lip | Observing the change in the non-affected lip height (mm) from the subnasal point to the labral superior point by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in the height of the cleft lip | Observing the change in the affected lip height (mm) from the subnasal point to the labral superior point by the superimposition of the 3D facial scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the alveolar cleft width | Observing the change in the alveolar cleft width (mm) from the most lateral to the most medial points at cleft edges by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in arch perimeter | Observing the change in the arch perimeter (mm) from the most left and right posterior points by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in greater segment perimeter | observing the change in the greater segment perimeter (mm) from the most posterior point to the most anterior point at the cleft edge by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1= after 1 month, T2= after 6 months, T3=after 1 year | 
| Change in lesser segment perimeter | observing the change in the lesser segment perimeter (mm) from the most posterior point to the most anterior point at the cleft edge by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in posterior width of the palatal cleft | observing the change in the posterior cleft width (mm) at the primary molars' gum pads by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in arch width at the anterior region | observing the change in the anterior arch width (mm) at the primary canine gum pads by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in greater segment rotation | observing the change in the angle between the greater segment and midsagittal plane by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2,T3 and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in lesser segment rotation | observing the change in the angle between the lesser segment and midsagittal plane by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 
| Change in arch width at the posterior region | observing the change in the posterior arch width (mm) at the primary molars' gum pads by the superimposition of the 3D occlusal scans at different time points (T0, T1, T2, T3, and T4) | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NAM, UCLP, pre-surgical orthopedics, DynaCleft