We understand how overwhelming it can be to navigate treatment options for your baby with a cleft lip with or without palate involvement. PLANA therapy is an innovative approach that offers effective presurgical results while prioritizing simplicity and caregiver support. Here’s everything you need to know about PLANA therapy and how it can benefit your baby.

What is PLANA therapy?

PLANA (Presurgical Lip, Alveolus, and Nose Approximation) therapy is a specialized presurgical treatment designed to improve the alignment of the lip, gums, and nose in infants with cleft lip. Using innovative devices, such as the NoseAlign device and LipAlign tape, PLANA therapy prepares your baby for surgery by reducing the severity of the cleft.

How Does PLANA Therapy Work?

PLANA therapy uses a combination of LipAlign tape and a NoseAlign device to approximate the displaced lip and nose structures caused by the cleft lip.

1) LipAlign Tape:

• A hydrocolloid adhesive tape is applied to the baby’s lip to bring the cleft lip edges closer together.
• Comes in three different sizes to accommodate the baby's progress.
• Easy to use and gentle on your baby’s delicate skin.

2) NoseAlign Device:

• A prefabricated, medical-grade silicone device that supports the displaced nose structures.
• Comes in three different sizes to accommodate the baby's growth.
• User-friendly and requires fewer office visits compared to traditional methods.

Together, these devices help to approximate the displaced nasolabial structures, making the surgical repair more straightforward and effective. 

Can PLANA Therapy Bring the Gums Closer Together?

Yes, PLANA therapy helps move the displaced gums closer together by applying gentle external pressure through the LipAlign tape and NoseAlign device. Research, including Randomized Controlled Trials (RCTs), has shown that lip taping alone can effectively reduce the gap between gum segments before surgery. With PLANA Therapy, all patients experience a significant reduction in the gum gap, contributing to improved presurgical positioning of the gums.

For more details click this link to read the RCT research study on PubMed

Benefits of PLANA therapy

1) Fewer Office Visits: PLANA therapy requires 60% fewer appointments compared to traditional methods like NAM, reducing the burden on families.

2) Gentle and Non-Invasive: Designed to be easy for caregivers to manage at home.

3) Simpler Surgical Reconstruction: Helps reduce the size of the cleft, align displaced nasolabial tissues, and improve facial symmetry, making surgical reconstruction simpler for the cleft surgeon.

Who Can Benefit from PLANA therapy?

PLANA Therapy is suitable for most infants born with cleft lip with displaced nasolabial structures. It is particularly beneficial for families looking for an effective alternative to more invasive or time-intensive therapies.

Do I need to get a dental mold for my newborn baby to start PLANA Therapy?

A: No, a dental mold is not required to start PLANA Therapy. Unlike other presurgical options like NAM, PLANA Therapy uses prefabricated devices such as the NoseAlign Device and LipAlign Tape, which do not rely on custom-fitted mold. This makes the process simpler, more accessible, and less invasive for your baby.

How to Get Started ?

1) Consult Your Cleft Team: Talk to your baby’s cleft team specialist or cleft surgeon to see if PLANA therapy is the right fit for your baby.

2) Enroll in the Program: Once recommended, you’ll receive training from your cleft team on how to use the  NoseAlign device and LipAlign tape effectively.

3) Follow Your Baby’s Progress: Regular check-ins with your cleft team specialist will ensure your baby is on track for surgery.

Q: When should we start PLANA therapy?
A: Starting within the first two weeks after birth is ideal. Early intervention helps take advantage of your baby’s natural tissue flexibility, leading to better alignment of the lip and nose before surgery. Starting later may still offer benefits but might not achieve the same level of presurgical improvement.

Q: Does the NoseAlign Device hurt my baby?
A: No, the NoseAlign Device is designed with your baby’s comfort in mind. Made from soft, medical-grade silicone, it gently supports the displaced nasal cartilages without causing pain or irritation. Most babies adapt to wearing the device quickly, and your cleft team specialist team will guide you on how to insert the NoseAlign device. Please contact your cleft team specialist if your baby shows signs of discomfort.

Q: How often do I need to change the LipAlign Tape?
A: LipAlign Tape should be replaced every 24 hours to ensure it maintains its effectiveness and adhesion. A consistent routine also helps avoid skin irritation and ensures the tape continues to provide a gentle but effective approximation of the cleft lip.

Q: What makes PLANA Therapy different from other presurgical options?
A: Unlike traditional methods like NAM, PLANA therapy is less invasive and requires fewer office visits, making it more convenient for families. The NoseAlign device and LipAlign tape are user-friendly and can be managed at home with minimal stress. This therapy focuses on simplicity without compromising the quality of outcomes.

Q: Will PLANA Therapy interfere with my baby’s feeding?
A: The NoseAlign device does not go into the mouth, so it doesn’t interfere with feeding. The LipAlign tape is placed externally, which also has no impact on feeding. If your baby uses a special feeding bottle due to their cleft, you can continue to do so without issues.

Q: How long will my baby need to continue PLANA therapy?
A: The duration depends on the severity of your baby’s cleft and their progress, but most infants continue PLANA therapy until the time of their primary surgery, which is typically between 3-4 months of age. Your cleft care team will monitor progress and adjust the therapy as needed.

Q: What if my baby has a bilateral cleft? Can PLANA therapy still help?
A: Yes, PLANA Therapy is effective for both unilateral and bilateral clefts. The NoseAlign Device and LipAlign Tape are universal tools that can be adapted to suit your baby’s specific needs, ensuring optimal presurgical preparation for bilateral cleft repairs.

Q: Are there any risks or side effects with PLANA therapy?
A: PLANA Therapy is designed to be safe and non-invasive. While rare, some babies may experience minor skin irritation from the NoseAlign device or LipAlign tape. Using the device and tape as directed by your provider and following recommended skin care routines can help prevent irritation. If you notice persistent redness or discomfort, contact your cleft care provider as soon as possible.

Q: What if I have trouble applying the NoseAlign Device or LipAlign tape?
A: We understand that learning to use these devices may take time. That’s why your cleft team specialist will provide step-by-step demonstrations and personalized support to help you feel confident. Your cleft team specialist will be available to answer your questions and troubleshoot any issues.

Q: Is PLANA therapy covered by insurance?
A: Coverage varies depending on your insurance provider and policy. It’s a good idea to contact your provider to discuss your plan’s coverage for cleft-related therapies. Your cleft team can assist with documentation and provide guidance to help with the reimbursement process.

Q: How can I track my baby’s progress with PLANA therapy?
A: Regular photos and check-ins with your cleft care team will help monitor progress. Many families find it helpful to take weekly pictures to document changes in their baby’s lip and nose shape. This also allows your care team to make real-time adjustments to the application of the NoseAlign device or LipAlign tape if needed.

Q: Can PLANA therapy prevent surgery?
A: No, PLANA therapy is not a substitute for surgery. Instead, it prepares your baby for surgery by reducing the size of the cleft, aligning tissues, and improving facial symmetry, which helps ensure better surgical outcomes and reduces the risk of complications. However, PLANA therapy can avoid the lip adhesion surgery sometimes performed to reduce the cleft severity before the definitive reconstructive surgery.

Q: How often do I remove the NoseAlign device?
A: The NoseAlign Device must be removed at least once daily for cleaning and during bath time. This also gives you an opportunity to check your baby’s skin for any signs of irritation or discomfort. It’s essential to ensure the device is reapplied promptly to maintain consistent progress.

Q: How do I clean the NoseAlign device?
A: Clean the NoseAlign Device daily using cold water or saline or mild, baby-safe soap. Gently scrub the inside of the device tube with a fine-tip brush, rinse thoroughly, and allow it to air dry before reapplying it to your baby. Avoid using harsh chemicals or abrasive materials to ensure the device remains safe for your baby’s delicate skin.

Q: How do I determine which size of the NoseAlign device I should use?
A: The NoseAlign Device comes in multiple sizes to accommodate your baby’s growth and the severity of the cleft. Your cleft care team specialist will assess your baby’s needs and recommend the appropriate size during the initial fitting. As your baby grows or progresses with therapy, the size may need to be adjusted. Regular check-ins with your care team specialist will help ensure the right fit.

Q: Can I reuse the LipAlign tape?
A: No, LipAlign tape is designed for single-use and should be replaced every 24 hours. Reusing the tape may reduce its adhesive strength and effectiveness and could increase the risk of skin irritation or infection. Each box includes a sufficient supply to ensure you have a fresh tape for daily use.