Provider FAQs

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Is the Clench Relief® Pro Rx Mouthpiece cleared by the FDA?

Clench Relief® is FDA 510k cleared for short-term treatment of TMD pain and associated headache and bruxism, and for relief of muscle tension in the head and neck. Clench Relief® is patented.

What makes Clench Relief® Pro Rx Mouthpiece different from other TMJ treatment devices?

Clench Relief® Pro Rx Mouthpiece offers a unique combination of rapid fabrication and effective symptom relief without the need for a lab or extended turnaround times. Unlike traditional splints or nightguards, Clench Relief® Pro Rx Mouthpiece can be fabricated chairside within minutes, allowing for immediate patient relief without delays. Compared to QuickSplint, which is designed as a temporary anterior bite guard, Clench Relief® Pro Rx Mouthpiece provides a custom-fitted, full-arch stabilization that maintains the mandible in an optimal resting position for extended wear.

While other treatments like Botox, physical therapy, and surgical intervention have their place in TMD management, Clench Relief® Pro Rx Mouthpiece serves as a conservative first-line approach that is non-invasive, cost-effective, and easy to integrate into treatment protocols. Its design promotes muscle relaxation and joint decompression, making it a valuable tool for both acute symptom management and long-term stabilization.

What certifications does Clench Relief® have?

Clench Relief® Pro Rx Mouthpiece is FDA 510(k) cleared, confirming its safety and effectiveness as a prescribed oral appliance for TMD management. Additionally, Clench Relief® Pro Rx Mouthpiece Inc. has submitted payment to be formally listed in the FDA database as a registered selling entity, ensuring full regulatory compliance for distribution.

What evidence supports the effectiveness of this device?

While no formal clinical studies have been conducted yet, Clench Relief® Pro Rx Mouthpiece has been successfully prescribed by doctors to dozens of patients, demonstrating consistent reductions in pain and muscle tension. In qualitative testing, patients reported an average reduction in pain from a 7 to a 3 on a 0-10 scale, reinforcing its effectiveness as a conservative TMD therapy.

The design is rooted in biomechanical principles that promote neuromuscular relaxation, joint decompression, and occlusal stability, aligning with standard approaches to TMJ disorder management. As clinical use expands, further data collection will continue to refine and validate its efficacy.

Does the Clench Relief® Pro Rx Mouthpiece cover the lower or upper posterior teeth?

It's seated on the lower posterior teeth.

What allows the patients to achieve a bite in the “Zone of Comfort” with the Clench Relief® Pro Rx Mouthpiece?

Creating a balanced posterior occlusion with no anterior contact with the lower jaw in a forward-centered position can indeed be beneficial for certain dental conditions or treatments. Here’s why it works!

1. Balanced Posterior Occlusion:
This refers to achieving an even distribution of forces on the back teeth (posterior teeth) when the jaws come together. This balance helps in keep the muscles calm and relaxed and minimizes stress on the jaw joints.

2. No Anterior Contact with the Lower Jaw and centered over the wear patterns of the teeth:
This means that when the jaws are in a closed position, there is no contact or pressure on the front teeth (anterior teeth) of the lower jaw since its purposely suspended and centered above the wear facets. This can be important in cases where there are issues with tooth wear, jaw misalignment, or temporomandibular joint (TMJ) problems since the muscles have created these wear patterns over time.  The Clench Relief® Alignment Guide is beneficial in allowing the patient to end up in this corrective physiologic position!

3. Forward-Centered Position:
The lower jaw (mandible) is positioned forward from its usual biting position as the muscles can relax more. This forward positioning can be beneficial in situations by improving airflow during sleep and patients can wake up without muscle soreness or tension.

4. Clench Relief® Fit Material:
The Polyvinyl siloxane fit material is beneficial in the fitting process as it engages into the spaces of the upper and lower posterior teeth while the patients is closed onto the anterior alignment guide. This process is designed to help maintain the relaxed and centered position of the lower jaw as guided by the alignment guide while the fit material hardens over the next ten minutes.

Overall, the goal of using these tools and techniques is to optimize jaw alignment, reduce strain on the teeth and jaw joints, and possibly alleviate head-aches, neck and muscle pain and certain dental or sleep-related issues. It's important for these procedures to be carried out by qualified dental professionals who can assess the individual's specific needs and tailor the treatment accordingly.

How long should a patient wear the Clench Relief® Pro Rx Mouthpiece?

The Clench Relief® Pro Rx Mouthpiece is designed for short-term use, typically up to 3 months. However, it can be worn for longer periods if necessary, but it's recommended to check both the patient and the mouthpiece every 3 months. This ensures that the mouth guard continues to provide the desired relief and remains in good condition. The PVS (Polyvinyl siloxane) material used in the mouth guard can be switched out at these intervals to maintain hygiene and functionality. If the Clench Relief® Pro Rx Mouthpiece has been effective for the patient and they wish to continue wearing a mouth guard for long-term use, the dentist can then consider transitioning the patient to a long-term lab-generated orthotic that holds the patient in a similar jaw position The dentist will assess the patient's needs and recommend the appropriate course of action for continued TMD treatment and management. Regular follow-ups and adjustments may also be necessary to ensure the orthotic continues to meet the patient's requirements.

Can I can take a bite registration for my lab with Clench Relief® Mouthpiece Frame and alignment guide for restorative prosthodontics?

Yes, you can take a bite registration using the Clench Relief® Pro Rx Mouthpiece. Whether you choose to use the frame with or without the alignment guide depends on the specific needs of the patient and the type of restorative or comprehensive dental treatment being planned.

Using the Frame with Alignment Guide:
1. If the patient has any history of  clenching, grinding, or TMJ issues, then the Clench Relief® Alignment Guide is integral to achieving the desired jaw position and comfort, you can use the mouthpiece with the alignment guide to take a bite registration. We advise doing a phase 1 fixed “trial bite” orthotic first in this bite position and allowing the patient to “test drive” it before going to final porcelain restorations. This will ensure that the new bite location is comfortable with muscles and joint are in the optimum position.

Using the Frame without Alignment Guide:
1.
If the patient's focus is on restorative or comprehensive dental treatment, and the specific jaw position enforced by the alignment guide is not required for the procedure, you can use the Clench Relief® Pro Rx Mouthpiece Frame without the alignment guide to take a bite registration.

2. You can also remove or cut some of the plastic lattices in-between the molar pads of the frame so that the patient can touch their own teeth together and remain in correct occlusion during the bite registration.

It's important to communicate with the patient and understand their treatment goals and dental concerns before deciding whether to use the alignment guide during the bite registration process. Additionally, consulting with the restorative dentist or prosthodontist who will be performing the comprehensive dental treatment can help in determining the most appropriate approach for taking the bite registration with the Clench Relief® Pro Rx Mouthpiece.

Does insurance cover the Clench Relief® Pro Rx Mouthpiece since its an FDA cleared RX prescription only mouthpiece for TMJ?

Yes! The Clench Relief® Pro Rx Mouthpiece is is an FDA cleared medical device for TMJ, head aches and muscle tension and can be billed to dental insurance companies for reimbursement.

How do I keep the Clench Relief® Pro Rx Mouthpiece clean?

We recommend cleaning the Clench Relief® Pro Rx Mouthpiece with just water and a tooth brush. Just gently brush the entire mouth piece. and thats it. After 3 months, you can swap out the Clench Relief® Fit Material and replace with a fresh new set.

Does the Clench Relief® Pro Rx Mouthpiece cover the lower or upper posterior teeth?

Clench Relief® Pro Rx Mouthpiece is designed to fit over the lower posterior teeth. The upper teeth are indexed into the fit material for patient comfort since the PVS will flow through the lattices of the mouth piece.

How do I order in bulk?

Ordering in bulk is straightforward. Simply visit our shop and choose the "Bulk Kit" variant. Each Bulk Kit allows you to produce 10 Clench Relief® Pro Rx Mouthpieces, ensuring you have the quantity you need for your practice.

What support do you provide for patients?

We do not provide direct patient support for those who have received Clench Relief® Pro Rx Mouthpiece through their provider. Patients should first consult with their prescribing provider for any questions or concerns. If further assistance is needed, providers are welcome to reach out to us directly for guidance.

How does the pricing strcuture work (wholesale vs. retail)?

Our pricing is wholesale for providers.

What training materials are available for my team?

We're actively developing a range of training resources tailored for our provider partners. In the meantime, if you’d like to request training for your team, please submit your request via our [Contact Us page], and we’ll be happy to assist.

General Payment & Order Information

What are my options for a refund or exchange?

We have a 30-day return policy, which means you have 30 days after receiving your item to request a return. For detailed information on refunds and exchanges, please refer to our [Refund Policy page]. If you have any further questions or need additional assistance, our team is here to help.

Can I update my shipping address after I order?

We understand that plans can change. If you need to update your shipping address, please contact us as soon as possible and we'll do our best to accommodate your request.

What happens if I have issues with payment?

If you experience any payment issues, please contact us right away. We'll work diligently to address your concerns and resolve any problems as quickly as possible.

How long do orders take to process and ship?

We aim to process and package orders within one business day, though hand-packaging may occasionally require a bit more time. Once shipped via USPS, orders typically arrive within 2 to 7 days, with expedited overnight or 2-day shipping options available. Please refer to our [Shipping Policy page]. If you have any questions or need additional assistance, our team is here to help.