FAQ

FAQ – Frequently Asked Questions

How do I know the Dental Pain Eraser™ works?
  • The Dental Pain Eraser™ received FDA regulatory clearance (510k) for in clinic and home Rx use. The FDA clearance of medical devices for use on patients undergoes the most rigorous review and validation process in the world. The defined use of the Dental Pain Eraser is “for the reduction of pain in the oral cavity,” meaning it has broad application for many oral pain issues from tooth, to muscle/ligament, to soft tissue and bone pain related to ALL structures in the oral cavity.
  • In order for the Dental Pain Eraser™ to be on the market and used on patients, many successful, multi-site clinical validations were performed, demonstrating rapid (within 20 seconds) and lasting pain relief (up to 48 hours) with no side effects. Independent US University based, IRB double blind study peer reviewed validation, and additional independent fortune 500 company validation studies performed.
Why should I as a clinician (doctor, dentist, hygienist or nurse) use the Dental Pain Eraser™ in my day to day management of oral pain?

The Dental Pain Eraser™ can help reduce the fear of dental visits and increase dental office visits. Many clinicians are realizing the benefit of eliminating the anesthetic numbing of the patient during and after procedures, assisting in verifying tooth vitality, checking the correct bite with full tactile sensation present, and ease of use and delivery to the patient.

Additionally, because the Dental Pain Eraser™ works so quickly, it will allow dental professionals to perform procedures more quickly thereby freeing up dental chairs to make dental offices work more efficiently (reducing appointment times) and increase profitability.

Offering clinicians an alternative patient take home device that is safe and does not need an opioid or OTC pain prescription is another significant value-add the Dental Pain Eraser delivers. The office will also realize a cost savings and reduced need of multiple anesthetic delivery products.

 

Can the Dental Pain Eraser™ eliminate the need for a needle during dental or oral procedures?

The Dental Pain Eraser™ can help reduce the fear of dental visits and increase dental office visits. Many clinicians are realizing the benefit of eliminating the anesthetic numbing of the patient during and after procedures, assisting in verifying tooth vitality, checking the correct bite with full tactile sensation present, and ease of use and delivery to the patient.

Additionally, because the Dental Pain Eraser™ works so quickly, it will allow dental professionals to perform procedures more quickly thereby freeing up dental chairs to make dental offices work more efficiently (reducing appointment times) and increase profitability.

Offering clinicians an alternative patient take home device that is safe and does not need an opioid or OTC pain prescription is another significant value-add the Dental Pain Eraser delivers. The office will also realize a cost savings and reduced need of multiple anesthetic delivery products.

 

How long does the Dental Pain Eraser™ last? Is it rechargeable?

The Dental Pain Eraser™ clinical and take-home models have been programmed to shut off after a set time limit to ensure a maximum power and nerve blocking energy wave can be delivered to block the nerve pain signal. Current models are disposable and are not rechargeable and have the following time limitations of function:

  • The Dental Pain Eraser™ clinician model with replacement tips (Professional Chairside Kit, model C300) is programmed to last 330 minutes after which it is then discarded.
  • The Dental Pain Eraser™ patient Rx home model (Home Device, model T300) is programmed to last 100 minutes after which it is then discarded. During our introductory component of patient care, we will be allowing a slightly longer activation time to ensure that patients and offices can become more accustom to use.

Future models will be rechargeable via inductive charge and will have many varying applications on top of pain relief.

Is the Dental Pain Eraser™ safe for kids or only adults?

The Dental Pain Eraser™ has been cleared and approved for use of children and adults. Currently validation and use are for children age 10 and above with observation by an adult.

The Dental Pain Eraser™ is extremely safe with nearly zero possibility of adverse effects, allergic reaction, or harm to a patient.

The over the counter (OTC) unit which is in the approval process will be used for infants who are experiencing teething pain.

Did we receive clinicals on sensitivity relief?

Data on dental pain and sensitivity was utilized for FDA clearance. Dental pain and sensitivity  from an industry leading dental manufacturing and sales company performed their own independent internal study with 12 of their own selected Key Opinion Leaders (KOLs), validating the effectiveness of dental pain and sensitivity relief, especially in the use of de-bond orthodontic high speed polishing hypersensitivity.

Several key independent KOL’s from that study, including Dr. Chad Harrington, Dr. Mark Coreil, and many others have completely converted their private practice models to include the Dental Pain Eraser in the de-bond protocol for sensitivity relief.

Industry leading dental KOL, technology editor of Dental Products Magazine, and product evaluation expert, Dr. Paul Feuerstein, was selected for an independent review of the Dental Pain Eraser (DPE). He completed a nearly yearlong review of the product for sensitivity, aphthous ulcer pain relief, and dental pain, with validation and recommendation to several key product development avenues for further commercialization, distribution, and increased product awareness through education platforms.

How is the Dental Pain Eraser™ administered and how long does it take?

Administration is via 2 routes:

  1. Primary Route of Administration: Apply to buccal root surface (all the way up and down complete root surface) “erasing” vertical and lateral motion application for 30 seconds-this method “communicates” to the pulpal sensory complex via the lateral canal communication to the nerve, PDL neural complex, attached and mucosal neural complex and apical nerve communication.
  2. Secondary Route of Administration: Direct contact enamel/dentin applying for 30 seconds per tooth to continuous application dependent on the procedure being performed (evaluating variables such as restorations present, anatomic changes such as “pulpal capping/repair” from prior “trauma”). This administration route requires understanding of what technique is being utilized such as restorative removal of decay, blocking cold sensitivity during root exposure, and trauma to dentition to name a few examples.
How fast does the Dental Pain Eraser™ work?

Independent studies have verified the vast majority of pain relief is achieved in under 2 minutes for multiple areas/complex individual dental pain. In many independent tooth sensitivity aspects, and soft tissue pain such as canker sore relief it takes as little as 20 seconds per tooth or site.

What is Dental Pain Eraser™’s method of action (MOA)?

The simple answer is the research proven discovery and development of sub-sensory waves of electric energy that is delivered via a specialized probe to the area of nerve bundles blocks the electrical nerve signal from ever causing a pain signal in the brain. This is called neuro-modulation.

Advanced Pulswave Technology

More advanced description:

Pain sensory fibers in the periodontal complex (including supporting mucosal tissue, attached gingival, periodontal ligament, attachment fibers, dental structure including dentinal tubules with odontoblasts, pulpal tissue, and neural complex leading to ganglia) are blocked using sub-sensory High Frequency Kilohertz Alternating Current (HFKAC) used in the Dental Pain Eraser.

Blocking of pain fiber action firing, which also includes odontoblasts below relating to dental hypersensitivity, will also block the release of neurotransmitters and neuropeptide cascade pain response.

Blocking of neuropeptides such as Substance P can also reduce the vasodilation, mast cell activation (histamine response), and reduce swelling and inflammation in the area.

Another neuropeptide that is blocked or reduced is Calcitonin gene-realted peptide (CGRP). CGRP is a 37-amino acid peptide found primarily in the C and Aδ sensory fibers arising from the dorsal root and trigeminal ganglia, as well as the central nervous system. Calcitonin gene–related peptide was found to play important roles in cardio-vascular, and sensory functions. Although the vasodilatory properties of CGRP are well documented, it has been shown to modulate neuronal sensitization. CGRP plays a key role in the development of peripheral sensitization and the associated enhanced pain. Calcitonin gene–related peptide is implicated in the development of neurogenic inflammation and it is upregulated in conditions of inflammatory and neuropathic pain. It is most likely that CGRP facilitates nociceptive transmission and contributes to the development and maintenance of a sensitized, hyper-responsive state not only of the primary afferent sensory neurons but also of the second-order pain transmission neurons within the central nervous system, thus contributing to central sensitization as well.

Dentine hypersensitivity and pulpitis-associated pain are among the most common types of dental pain. Patients with these conditions feel pain upon exposure of the affected tooth to various external stimuli. Numerous ion channels and receptors localized in the dental primary afferent neurons (DPAs) and odontoblasts have been implicated in the transduction of dental pain, and functional expression of various polymodal transient receptor potential (TRP) channels has been detected in DPAs and odontoblasts. External stimuli-induced dentinal tubular fluid movement can activate TRP channels on DPAs and odontoblasts. Blockage of the ionic potential and firing of the “neuronal” properties of the odontoblasts with the DPE, can in turn block the DPAs by paracrine signaling through ATP and glutamate release.

In pulpitis, inflammatory mediators may sensitize the DPAs. DPE current delivery through dentinal tubules, lateral canal pulpal communication, can also block DPA sensitization. This will in turn block post-translational modifications of TRP channels, decrease increase trafficking of these channels to nerve terminals, and decrease the sensitivity of these channels to stimuli.

In our studies, we found that the pain relief from one single administration of DPE, providing pain relief relating to dental and periodontal pain for up to 48 hours. The main methods that this can occur are divided into peripheral and central mechanisms of pain reduction.

Peripheral system of pain reduction occurs by blocking the cascade effect of the neurotransmitter and neuropeptide response relating to sensory pain. This can occur directly through reduction of the firing of the above discussed odontoblastic method, and by direct block of pain fibers in the pulp directly.

The immediate block of pain when applying it directly to the tooth surface prior to a polishing (ionic air and pressure change in the tubule), tells us that the ionic potential on the odontoblast cell has been disrupted, preventing firing and sensitization of the polishing procedure that is to follow.

The central system of pain reduction occurs by communicating directly to ganglia and brain, causing a communication change in the process of pain response, signaling the central system to “shut down” pain response centers temporarily.

How often is the Dental Pain Eraser™ administered?

Please download the Clinical Guide to the Dental Pain Eraser Booklet for more information.

How do I use the Dental Pain Eraser™?

This video showcases simple instructions that will help you start using the Dental Pain Eraser today.

How do I clean the device at home? Can I put it under water?

There are care instructions in every T300 instructions, but cleaning the unit and tips after use is easy with light rinse with water, and sterilization with a cotton application of 70% alcohol of the probe tips, before re-application of protective cap. The Dental Pain Eraser is not designed to be submerged under water for any long period of time, but can be rinsed after use.

Can I apply the Dental Pain Eraser for too long a time? Is it safe to do this?

Though the packaging and instructions say do not exceed 10 minutes of application to any one area, it is extremely safe and applied to many tissue types for days and sometimes even years (implanted in the spine for lower back pain relief).

Are there any contraindications or conditions that make use risky?

The current contraindications:

  • Patients who are pregnant (though once again really safe in the category as we are nowhere near any biological cellular effect on child development)
  • Patients with seizures (no known cross effect to patients with seizures but would need to do too much cross testing on seizure patients to get clearance)
  • Patients with pacemakers (once again, this is a 1970’s issue and all new technology does not provide systemic energy that can affect cardiac function but once again, would need to do too much cross testing on cardiac patients to get clearance).
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