Nasoalveolar Molding, Unilateral Cleft Lip
Conditions
Keywords
NAM, UCLP, pre-surgical orthopedics, DynaCleft
Brief 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.
Detailed 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.
Interventions
DEVICENaso 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.
DEVICETaping 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
Innovinity medical hub
Smile train
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The study will be single-blinded. The outcome assessors will be blinded as the measurements will be done on laser-scanned casts and 3D facial images. The operator and the patient's parent cannot be blinded due to the nature of the intervention.
Intervention model description
A randomized clinical trial, parallel arm, superiority framework with 1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the height of the cleft lip | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in nasal tip projection | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| change in Columella height | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in projection alar length | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in width of the nostril | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in nasal basal width | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in the angle of the columella | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in cleft lip segment | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in the height of the non-cleft lip | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in the alveolar cleft width | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in arch perimeter | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in greater segment perimeter | T0= before Intervention, T1= after 1 month, T2= after 6 months, T3=after 1 year | 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) |
| Change in lesser segment perimeter | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in posterior width of the palatal cleft | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in arch width at the anterior region | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in greater segment rotation | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in lesser segment rotation | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
| Change in arch width at the posterior region | T0= before Intervention, T1=immediately before surgery, T2 1 month after surgery, T3= 6 months after surgery, T4= 1 year after surgery | 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) |
Contacts
Primary ContactAbdallah Bahaa, M.Sc.
Outcome results
None listed