Cleft Lip, NoseAlign, CleftAlign

The goal of PLANA therapy is to reduce the initial cleft severity before the primary surgery of the lip and nose by

1) Approximating the displaced cleft lip segments

2) Approximating the displaced alveolar segments in infants with unilateral cleft and the displaced premaxilla in infants with bilateral cleft

3) Approximating the displaced external nose structures

PLANA uses a NoseAlign©-cleft nose approximation device in combination with Lipalign medical adhesive tapes to achieve these goals.

Eliminates the necessity for lip adhesion surgery to narrow the cleft before undergoing definitive reconstructive surgery.

Approximating the cleft lips before surgery will reduce the tension in the lips during the healing, reducing the hypertrophic scar formation (Papathanasiou, Trotman et al. 2017).

Approximating the nasal cartilage during the first three months of life improves the long-term stability of the nasal form (Matsuo and Hirose 1988).

Approximating the displaced alveolar segments, brings the overlying soft tissues closer together, thereby facilitating the closure of the lip and reconstruction of the nose during primary reconstructive surgery.

PLANA with NoseAlign is an innovative therapy that provides high-value pre-surgical care by effectively reducing the severity of the cleft before primary reconstructive surgery. Here's why it excels:

⏱️ Efficiency and Convenience: Streamlining the treatment process with significantly fewer office visits and empowering caregivers with a user-friendly approach, enhancing compliance with the treatment protocol.

💡 Prefabricated Design: NoseAlign devices are prefabricated with medical-grade silicone, eliminating the need for a dental laboratory or a technician to fabricate and adjust custom appliances

PLANA employs LipAlign- lip tape to approximate the displaced upper lip before primary surgery in infants diagnosed with clefts. When the lip tape is applied to the lip with careful tension, its elastic nature causes the lip segments to be pulled together, resulting in a gradual reduction of the gap in the cleft. Taping is applied continuously and periodically changed to accommodate the infant's growth. The duration of use depends on the specific needs of the infant and the timing of the planned surgical intervention. By narrowing the cleft and improving the lip alignment, lip taping can make the subsequent surgical repair easier and more effective. It is of utmost importance to highlight that lip taping is typically conducted under the supervision of healthcare professionals, such as cleft teams or specialized cleft care experts, to ensure accurate application and monitoring.

The combined action of the LipAlign lip tapes and the NoseAlign device helps to reduce the gap in the alveolar ridge by gradually bringing the alveolar segments closer together. The horizontal lip band of the NoseAlign device, along with the tension from the orthodontic elastic and Steri-Strip tapes supporting the device, provides gentle extraoral pressure to approximate the alveolar segments.

Asymmetric elastic tension is typically recommended to approximate the greater alveolar segment towards the lesser segment for infants with unilateral cleft. In infants with bilateral clefts and an asymmetric premaxilla, this method can also be used to center the premaxilla.

Additionally, the tension from the LipAlign lip tapes further assists in the overall approximation of the alveolar segments. The precise elastic force and tension in the lip tape and orthodontics elastics are determined by the supervising specialist on the multidisciplinary cleft team.

The NoseAlign device, inserted in the nostril and secured by orthodontic elastics and medical adhesive tapes, provides gentle support to the soft tissue of the nose displaced by the cleft. Specifically, the tubular portion of the NoseAlign device supports the collapsed upper and lower nasal cartilages, the displaced columella, and the deviated nasal septum prior to primary surgery.

In infants with a unilateral cleft, the NoseAlign device can be used to center the deviated nose using asymmetric elastic tension. For infants with bilateral cleft, the NoseAlign device can also help center the premaxilla and control its vertical position by adjusting the vector of the supporting tapes and elastics.

The NoseAlign device is available in three different sizes. The treating cleft team specialist starts with NoseAlign size #1 and may transition to sizes #2 and #3 in the second and third months, respectively, based on the infant's progress and growth.