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    333 E 30th Street, New York, NY 10016

    Email: info@cleftalign.com

WELCOME TO INNOVATIVE PRESURGICAL THERAPY FOR PATIENTS WITH CLEFTS

 

 

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Current PSIO Methods Challenges Include 

  1. • Complex appliance design requiring specialized training.

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  3. • Requires a dental impression within one week of birth to fabricate a custom appliance.

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  5. • Infants undergo an adaptation period to the custom appliance for feeding, with the potential for intraoral cheek and gum irritation.

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  7. • Involves multiple office visits for appliance adjustments, leading to longer in-office appointments.

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  9. • Therapy duration extends from 4 to 6 months.

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  11. • Poses a potential risk of causing a mega nostril.

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Advantages of PLANA therapy using LipAlignTM Tapes and  NoseAlign® Devices 

  • Infants adapt quickly to the NoseAlign®  device.
  • Easy for the caregiver to use.
  • No intraoral plate, so no interference with the feeding. 
  • No potential for developing intraoral sores.
  • No risk of creating mega nostril.
  • Reduces the number of office visits (4-5), therefore ideal for patients living far from the cleft centers. 
  • Therapy duration 11 to 12 weeks of NoseAlign® use
  • Shorter in-office visit duration.
  • No dental impression is needed as the device is prefabricated.
  • No need for a dental laboratory for the device adjustment.
  • NoseAlign® device supports the displaced soft tissue nasal structures within the first 2 weeks to take advantage of the plasticity of the nasal soft tissue and the cartilage (Matsuo and Hirose 1988).
  • NoseAlign© device is universal and can be used for infants with unilateral and bilateral clefts (complete and incomplete).

 

 

Matsuo, K. and T. Hirose (1988). "Nonsurgical correction of cleft lip nasal deformity in the early neonate." Ann Acad Med Singap 17(3): 358-365.

 

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INNOVATIVE SOLUTION FOR PRE-SURGICAL THERAPY -PLANA

Presurgical Lip,  Alveolus, and Nose  Approximation (PLANA) is an innovative solution for infants with cleft lip and palate that uses NoseAlign®  devices and LipAlignTM medical adhesive tapes to approximate displaced nasolabial structures. The NoseAlign® device is simple to use in patients with incomplete and complete unilateral or bilateral clefts in conjunction with OTC medical adhesive tapes and orthodontic elastics. The device is prescribed and supervised by a treating physician or a dentist. 

The NoseAlign® device can be used daily for 20-22 hours and the device must be removed for cleaning at least twice a day. The device is available in 3 different sizes and the prescribing physician/dentist will usually start with lip tape and NoseAlign® device size # 1. Each device is used for up to 3-4 weeks, and the device size needs to be changed to keep up with the growth of the face. The decision to transition to the next size of the device is determined by the treating physician or dentist. Generally, the three different sizes of NoseAlign® devices are employed for a total of 9 to 12 weeks, and they are discontinued immediately after the primary reconstructive surgery of the cleft lip.