Category Archives: NiteBite

NiteBite® Is Your First Stop on the Road to Stopping Clenching, Grinding

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Every day, dentists want to maximize on their return of time invested in treating their patients. Ever since the introduction of Keystone’s NiteBite® product, this has become a much more achievable accomplishment.

NiteBite helps patients treat their TMJ/TMD disorders, with a patented design that utilizes the most innovative technology on the market of night guards. The design stops users from the clenching and grinding that goes on while they sleep, and is the first FDA-cleared device to function within the freeway space. On top of this, NiteBite will cut out the headaches, tooth and jaw pain that some patients may have as well.

NiteBite can prevent bruxism, and help treat TMJ/TMD disorders.

NiteBite can prevent bruxism, and help treat TMJ/TMD disorders.

NiteBite is satisfying for both the patient and the applying dentist. With ease for both, there’s hardly any wait time, as it takes just a few quick minutes for the dentist to apply the guard, and it fits directly into the patient’s mouth without an impression, procedure, or return visit. The benefit of muscle relaxation and pain relief is provided almost immediately from NiteBite.

Now that you know a little bit about NiteBite, you may question why you should need this over any other competing night guard. Below are the compiled main features of this innovative product:

  • Stops bruxing and clenching
  • FDA cleared for use by dental professionals
  • Inserts, molds and fits in 5 minutes
  • No second patient visit
  • No lab time or expense
  • Custom fit for each user (in office)
  • Easy to fit and very comfortable to wear
  • Extremely safe and easy to use
  • Clinically proven to be effective
  • Most profitable occlusal appliance on the market
  • Little or no adjustment is needed
  • Prevents TMJ/TMD syndrome
  • Relieves chronic tension and pain within the head, jaw and neck neuromuscular system
  • Available through your distributor

You can get more information about NiteBite and plenty of other U.S. dental products on Keystone Industries website, or you can contact Keystone Industries directly toll-free at 1 (800) 333-3131 or fax (856) 663-0381. Socialize with us on Facebook, Twitter, Google+, and LinkedIn as well!

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The Ultimate Guide to Oral Health [INFOGRAPHIC]

In this infographic provided to us by the American Dental Association, the best practices to maintaining excellent oral health are explained as visually as possible. Everything from the gear you need to picking a dentists, this graphic has you covered.

You can find a lot of products to help keeping a good oral health lifestyle for yourself and patients at your dental practice on our website, keystoneind.com.

Do you have any specific or different daily routines related to keeping good oral health? Let us know in the comments below.

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NiteBite®: A testimonial

See how NiteBite® can help in this testimonial video from Dr. Kaminer.

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NiteBite® For Your Practice

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Your dental practice will be greatly enhanced when you pursue the preventive incentive with NiteBite®.  Many goals of minimally invasive, preventive oriented dental practices can be realized using the unique treatment advantages of NiteBite.  You ensure your patients’ dental health investment when you use NiteBite. The NiteBite’s ease of use and 5-minute fitting and insertion by you or your hygienist creates not only immediate relief for your patients but also creates an economical and profitable return for your practice.  NiteBite is a practice builder.

Using the NiteBite early in a treatment plan will immediately reduce TMJ/TMD symptoms.  Patients will appreciate instant comfort and relaxation as the NiteBite eliminates the damages of stress, tension and the parafunctional occlusal and muscle problems of grinding and clenching. The NiteBite will reduce pain in and around the head and neck; eliminating muscle spasms and nighttime clenching and grinding.  Bruxism is eliminated.

NiteBite can prevent bruxism, which increases effects from periodontal disease.

NiteBite can prevent bruxism, which increases effects from periodontal disease.

When a patient receives a NiteBite future treatments will be greatly reduced. The NiteBite is a preventive dental, minimally invasive device that operates as the jaws opening reflexes achieve a “non-contacting” intra-oral relationship. Wear facets and wear patterns, worn down and loose teeth, broken teeth and broken restorations are prevented as the NiteBite maintains the jaws at a fully rested, non parafunctional, relaxed and centric oriented relationship.

The success of periodontal treatment will improve as the NiteBite eliminates eccentric mandibular contact and the forces of bruxism. Post-operative stabilization is enhanced. The teeth will not touch at night as the jaw opening reflex is triggered by the NiteBite.

“Hot” or endodontically involved teeth are easily discluded with the aid of the NiteBite. Grinding and clenching at night is reduced and eliminated.

Post-operative final and temporized crown and bridge work is protected by preventing bruxism on new occlusions and materials.

All these reasons add up to “using the NiteBite first” in your prevention and treatment protocols.

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Examining, diagnosing and treating bruxism

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All new or recall patients coming to your office should be examined and observed for the signs and symptoms of bruxism. Oftentimes, a dental office’s duty is to educate home oral health care, yet education on bruxism lacks. Now’s the time to examine, diagnose and treat bruxism all while chairside.

During the late 1960s and 1970s, Dr. Robert Barkley of Macomb, Ill., shifted dental health responsibility to the patient through teaching home care, plaque and disease process control. He felt this was the only effective way to break the cycle of recurring dental disease  He taught “not practicing prevention by providing preventive training and plaque control techniques is similar to putting good wood (restorations) into a building with a fire in the basement (periodontal disease)”. Dentist offices have now become proficient in practicing the techniques and disciplines of Dr. Barkley by instructing patients in proper daily flossing and brushing techniques along with disease process education. Recall patients need to demonstrate a lack of bleeding gums and reduced caries by showing their commitment to home care and “bottom-up” preventive dentistry.

NiteBite can prevent bruxism, which increases effects from periodontal disease.

NiteBite can prevent bruxism, which increases effects from periodontal disease.

The damages and pain of bruxism must also be prevented and controlled by a dental team. This is true not only for the TMJ and neuro-muscular systems but for the anatomical and restored structures of the natural teeth. Life expectancy increased from 50 years in 1910 to over 75 years today. Dentistry is challenged to maintain teeth, oral structure and restorations techniques in light of the effects of time and stress. To help accomplish long-term health and function it’s necessary to reduce the amount of force and stress that the teeth encounter daily. The dentist must identify the signs and symptoms of wear, breakdown and parafunction and attempt to slow, stop or reverse the process. Using the NiteBite® first to prevent wear and eliminate the many effects of bruxism should be strongly considered.

To immediately identify bruxism and its effects, the following list of signs and symptoms will aid the dentist and hygienist to provide the necessary preventive services. Remember to try the NiteBite first to stop the bruxing pain and wear process. With the NiteBite in place, there is no tooth-to-tooth contact and the jaw muscles can relax.

BRUXISM CLINICAL CHECKLIST

 Limited jaw opening
•  Inability to open or close the jaw smoothly or evenly
•  Jaw moves to one side when opening
  Inability to find natural and comfortable way to close teeth together
•  Clicking or popping jaw joints
•  Sensitive teeth
•  Wear facets and wear patterns
•  Worn down and loose teeth
•  Broken teeth and restorations

BRUXISM SYMPTOMS CHECKLIST

•  Muscle spasms or pain around jaw joints
•  Pain around the face, eyes or head
•  Frequent headaches or jaw aches, especially in the morning
•  Clenching or grinding
•  Pain in cheek muscles
•  Neck, shoulder and upper back pain
•  Chipped incisal edges
•  Irritation of the cheeks and tongue (linea alba)
•  Pain in the muscles surrounding the temporomandibular joints
•  The jaw locking open or closed
•  Ringing in the ears, ear pain, and ear congestion
•  Insomnia

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NiteBite hits the floors of Yankee Dental 2014

Check out this video on NiteBite. More proof this is a game changer for practices across the world! Check out hashtag #stopthegrind and see what people are talking about NiteBite!

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Bruxism can increase the damage of periodontal disease

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Periodontal disease begins as gingivitis, which is a condition that is present in over 50% of the population in the U.S. Adult periodontitis, measured by the presence of periodontal pockets greater than or equal to 4mm, was found in about 30% of the population on an average of 3 to 4 teeth.1

Prevention of plaque buildup through daily brushing and flossing is the most effective means of controlling the loss of periodontal attachment and the deepening of pockets. If there is bleeding when flossing or brushing, gingivitis or advanced periodontal disease is present. In the presence of plaque buildup the inflammatory response of gingivitis will often occur and bruxism can contribute to the progression of periodontal disease.

Bruxism can create primary occlusal trauma leading to tooth mobility. Secondary occlusal trauma is a worsening of periodontal disease from the forces of bruxism. Prolonged grinding may result in the bone loss of advanced periodontal disease.

NiteBite can prevent bruxism, which increases effects from periodontal disease.

NiteBite can prevent bruxism, which increases effects of periodontal disease.

For a bruxer, treatment of the primary or secondary occlusal trauma could involve selective grinding or reconstruction of certain inter-arch tooth contacts. Employing a NiteBite® will protect the teeth from the greater than normal occlusal forces of the patient’s parafunctional habit. The bone loss or pocketing resulting from secondary occlusal trauma may require further treatment

When the NiteBite is installed in the patient’s mouth, parafunctional habits such as bruxism and clenching are effectively eliminated. When the NiteBite is in place during the night, the mandible comes to rest at the physiologic rest position as the result of the triggering of jaw opening reflex. At this position, none of the teeth are in contact with each other or the NiteBite. No occlusal trauma, primary or secondary, will occur at this time as there are no inter-occlusal forces on the teeth. The progression of periodontal disease caused by bruxing or clenching is ended.

  1. J Periodontology. 1998 Feb; 69(2):269-78. Periodontal disease in the United States Population

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NiteBite’s patent process and its journey onto the market

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After developing the form and function of the NiteBite® it became evident to us that we had a “better mousetrap”. It was obvious to us, but would it be evident to the Intellectual Property (IP) and legal world. Did we have a patentable device?

Patent searches were done to see if any bite devices were already patented, whether in use or not. If a device was patented or if its patent had expired and it spoke directly to our claims, we would have a difficult time in the United States Patent and Trademark Office (USPTO) obtaining patent coverage.

We studied each and every claim and patent found that came up in our searches. Since we could not find any previous language describing the unique form and function of the NiteBite, we decided to hire intellectual property attorneys and apply for a provisional patent.

No other bruxism device had been created that functioned only within the “freeway space”. No other device stimulated the jaw opening reflex allowing the mandible to return to the physiologic rest position. At the physiologic rest position, no anterior or posterior teeth would contact each other or the device. Bruxism would uniquely stop with the device in place during sleep.

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A computer aided design of the NiteBite. The finished product is white opaque in color.

The form and materials of the device would also have to be specified to show how the process of alleviating bruxism would occur. Uniquely reducing bruxism was the overall design and functional impact of our patent application.

There was a fixed time allowed by the USPTO to develop final application. Drawings with numbered references had to be produced consistent with the “patent-legalese” of the body and claims. Once the patent application was filed, there were a series of office actions, correspondences and interviews required honing down the language and intent of the application filing. There was much time and effort working with the PTO so that all aspects would be understandable to the patent examiners and that the uniqueness of the NiteBite would be evident.

Several claims allowances were ultimately issued. Indeed the NiteBite was declared by the USPTO to be a unique, patented device in its form and function. The NiteBite would help reduce TMJ/TMD distress and improve the health of the population.

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The two main functions of NiteBite®

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There are two main functions of NiteBite®:

1. To relax the jaw by using its natural physiologic processes.
2. To prevent bruxism and clenching by preventing the rear teeth from touching in centric or eccentric movements utilizing the jaw opening reflex.

The NiteBite functions using a thin rigid platform within the freeway space. As the lower anterior teeth approach the NiteBite, proprioception activates the jaw opening reflex and relaxes the jaw.

This proprioceptive activated reflex occurs during daytime chewing cycles as well and prevents the teeth from hitting each other during chewing cycles. This reflex allows the mandibular muscles to return the mandible to the physiologic rest position.

NiteBiteThe NiteBite platform creates an anterior vertical opening of about one millimeter, this distance being less than the average freeway space of about three to seven millimeters. The freeway space is the distance between physiologic rest and first contact of the anterior teeth in occlusion.

The NiteBite is NOT involved in the process of mastication or daytime chewing rhythms. It is worn only at night to prevent bruxism and clenching by activating the jaw opening reflex.

A brief survey of the literature indicates intra-oral jaw opening being innervated (jaw opening motion/reflex) by pressure stimulation to periodontal proprioceptor neural pathways. The jaw opening reflex movement is documented and recorded as active during the night and as moderated by sleep state sequences and levels.

Sleep movements are not masticatory movements although many of the muscles, nerves and pathways utilized are similar.

The NiteBite is functional during sleep with the mandible free to move within the freeway space. The mandible will only encounter the NiteBite’s thin anterio/palatal platform when the mandible attempts to close within the freeway space. Mandibular movement if allowed to create contact between mandibular and maxillary teeth is an initiator of parafunctional movements including bruxing. Most other devices are limited and block entry of the mandibular incisors into the freeway space and cannot activate the jaw opening relaxation reflex.

The NiteBite is patented for operating within the freeway space, functioning by using proprioception and jaw opening reflexes to bring muscles to a minimal isotonic state. This function will prevent the rear teeth from touching. Maintaining the mandible at physiologic rest prevents the initiation of parafunctional movements such as bruxism and clenching.

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NiteBite Clinical Case #2

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The next two weeks are examples of how bruxism is identified, diagnosed and treated. These are just a few examples of how NiteBite can quickly and easily treat many symptoms that affect many people. For more information read other NiteBite Blogs or go to the Keystone Industries website.

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A new patient presents at the dental office. Unlike the patient in NiteBite Clinical # 1, this patient’s clinical complaint is that she has noticed waking up in the night being aware of grinding her teeth. Her sleep mate tells her she makes a lot of noise at night as she grinds. Although her pain level is manageable she is concerned about the damage she may be doing to her teeth.

After a physical exam and X-rays to eliminate contributing conditions, the dentist recommends she try a simple appliance that, at the very least will protect her teeth from the effects of grinding by acting as a barrier between her upper and lower teeth. She has some considerable wear facets on her left working side cusps. He explains, however, that in the best case the appliance will trigger a jaw opening relaxation reflex to help relax the jaw muscles in addition to separating the posterior teeth. He explains that the muscles are in spasm and are likely initiating the grinding. He explains also that there are usually additional factors such as stress that help contribute to the grinding.

He recommends the NiteBite, explaining that she will be able to walk out of the office with the finished, custom fit appliance and begin wearing it that very night.

When there is an effective treatment, easily and instantly custom fit for the symptomatic patient, it should be the first option. There is a significant advantage to the patient and the dentist to quickly reduce symptoms. This treatment is valuable and worth a significant fee.

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NiteBite Clinical Case #1

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The next two weeks are examples of how bruxism is identified, diagnosed and treated. These are just a few examples of how NiteBite can quickly and easily treat many symptoms that affect many people. For more information read other NiteBite Blogs or go to the Keystone Industries website.

Mouth3This existing patient reports new symptoms to her dentist. She first mentions that she is under a lot of stress. Her husband has developed a serious illness and she’s found out her job is not as secure as she thought.

She tells the dentist she often wakes up in the morning with a headache and she has pain in her face, especially in front of her ears. Her face is tender to touch and her ear hurts to the touch.

The dentist notices that she has a furrowed brow. He checks the existing x-rays and does a clinical exam. The appearance of the intraoral soft tissue is normal, there is tenderness at the lateral pterygoid and there is no evidence of parotid or parotid duct involvement. He confirms the tenderness on the face, around the ear and at the temple and side of the head.

What should be the net step?  Do medications or appliances become the treatment of choice, or both?  With the ready availability of both medications and appliances, the dentist should consider the best way to offer rapid relief.  Anti-inflammatory medications, such as ibuprofen in combination with an appliance should offer the patient a degree of nearly instant relief.

The dentist has at his fingertips the NiteBite, an appliance that can be fitted in just a few minutes.  Its impact on the patient’s symptoms could be even more rapid then the effect of the ibuprofen.

He fabricates, adjusts and delivers the NiteBite and recommends that the patient take 400mg of ibuprofen every four hours for the next two days.  He will follow up with the patient in one week via a return visit to his office.

The combination of medications and the NiteBite should address the symptoms effectively reducing the inflammation and triggering the jaw opening reflex from within the freeway space to relax the muscles.

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How we forged NiteBite

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Once the requirements of the appliance were understood – see how we created NiteBite here – Dr. Marc Doctors and I began a four-year process of development. We knew NiteBite® had to be thin enough to fit within the space between the physiologic rest position and the first point of contact of the mandibular incisal edges with the lingual surface of the maxillary incisors. This is known as the freeway space. We knew that contact on the appliance within the freeway space would activate the jaw opening reflex allowing the mandible to physiologic rest.

We wanted a device that would be universal, i.e. properly fit in the oral cavity for 90%-95% of the adult population. We reviewed studies measuring the mesial -distal dimensions of the four maxillary incisors.  We observed arch radii and shapes from the distal of the right and left lateral incisors. We observed and measured heights of palatal vaults. We reviewed and measured incisor angles to the palate and the distances from incisal edges to crests buccal of curvature.

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NiteBite’s 3D rendering

We began to develop an overall peripheral shape of the device.  We knew it would have to be in the range of 1 to 1.5 mm-mm thick in order to fit next to the lingual aspect of the maxillary incisors within the freeway space. We also knew that the device needed to be made of two materials, a rigid outer surface where the mandibular incisors could have a reliable point of reference within the freeway space and a moldable material that could form buccally, lingually and palatally to the upper arch. It was decided that centric and lateral excursions of the mandibular incisors on the device avoid any contact of the posterior teeth. Also excursion onto the canines would be acceptable creating border stability with the mandibular condyles.  This range and envelope of motion would create a freeway space from where the mandible could return and reside at the physiologic rest position.

Prototypes were built using rigid plastic materials for the exterior surface and a moldable and secure thermoplastic for the tissue surface, i.e. a thermoplastic that would flow at less than the temperature of boiling water and become rigid and secure at body temperature.  Materials cleared for use by the FDA were selected and a CAD-CAM process was begun to develop working prototypes. Normalization of oral x-y-z axes were created by CAD-CAM software for transfer to machine tooling tolerances for manufacturing.

With the final shapes and materials determined, CAM programmed machine tooling processes were implemented for mass production and injection molding at ISO medical production facilities.

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What Makes Nitebite® Different From Other Devices

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Keystone Industries asked the creators of NiteBite® what makes their device so special? And this is what they had to say.

What makes NiteBite so special is that it triggers the jaw opening (relaxation) reflex.  This reflex occurs as the jaw closes and the incisor proprioceptors sense contact with the NiteBite. By triggering this reflex, the NiteBite stops clenching and grinding, resulting in relaxed muscles of the jaw, head, neck, and back. When muscles are relaxed, patients will sleep better and it is very common for patients to experience less headaches.

NiteBiteOther occlusal devices act as barriers between the upper and lower teeth and are too thick to function within the freeway space. They don’t eliminate grinding or clenching and therefore don’t reduce muscle activity or create muscle relaxation. These devices essentially prevent tooth-on-tooth contact with a barrier rather than stopping the problem.

Tooth wear stops when the NiteBite is worn because of this relaxation and the fact that the teeth don’t touch at all when the NiteBite is in place.

In addition, the NiteBite is very comfortable to wear.  Oftentimes, other appliances are very large and ridged, making it uncomfortable to sleep with. Patients can wear the NiteBite every night without feeling the need to remove it during sleep.

Getting fitted for a NiteBite only takes a few minutes in the dental office. No impressions, no lab wait time, no second appointment… All you need is 5 minutes!

The reduction in chair time and laboratory expense allows the practitioner to provide this occlusal service for the patient at a reduced cost, making more available to a greater number of patients.

NiteBite is truly a revolutionary product. How it works, how it’s implemented and how comfortable it is makes this device the most accessible sleep device in the world!

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How we invented NiteBite

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Dr. Marc Doctors and I, who have a combined 60 years of occlusal and clinical experience in observing treatments to control TMJD symptoms, decided to do a survey of occlusal devices and therapies that treat bruxism within the neuromuscular and occlusal systems of the head and neck. We were looking specifically at therapies that were effective and repeatable for the many clinical signs and symptoms related to jaw movement, function, dysfunction and disharmony.

Our survey led to a review of several therapeutic modalities:

1. Palliative treatment that is reversible utilizing medication, biofeedback, TENS, etc. for relief of pain or stress.

2.  Occlusal equilibration and/or restoration that considers centric relation, eccentric movements and vertical dimension through the cycles of functional movement.

3. Occlusal devices that attempt to dissipate and/or change forces on the teeth and periodontium through the placement of anterior or posterior inter-occlusal barriers.  These devices essentially attempt to lessen the damage to the teeth and TM joint with fabricated inter occlusal barriers. None of these devices prevent bruxism to the point where parafunction, stress and pain cease to occur.

In the survey, we included various posterior/anterior full or partial coverage splints to create disclusion while attempting to redistribute maxillary and mandibular forces on the teeth. Other devices also broadly included Hawley designs with or without canine guidance and barriers to allow posterior disclusion during centric or excursive movements.

As we studied occlusal and myofunctional movements, we observed that bringing the mandible to rest was the only physiologic solution to break the cycles of parafunction, in particular, bruxism.

NiteBiteIt became obvious that the best way to achieve bringing the mandible to rest at the Physiologic Rest Position was to create a device that prevented contact of the posterior teeth while not encroaching on the inter-occlusal freeway space.  Once these parameters were defined, the design of the NiteBite® evolved into a small, thin, anterior appliance that fit within the freeway space of all patients.  Should the patient close on the NiteBite centrically or eccentrically the posterior teeth are prevented from touching.

By building and designing the NiteBite to fit firmly over only the four upper anterior teeth, and to be as thin as possible at the incisal edge of these teeth, it was observed that the NiteBite triggered the jaw opening (relaxation) reflex, allowing the mandible to return to the Physiologic Rest Position and allowing relaxation of the jaw muscles.

Key NiteBite goals:
- We decided to focus on a device with these features that would fit the majority of patients with limited or no adjustments
- The device would not require a lab for delivery or fabrication and could be fit by a dentist, hygienist or trained auxiliary.
- The device would take only a few minutes (5-10) to fit for 90-95% of the patients without additional alteration.
- The device would take advantage of the best and latest FDA approved materials, computer aided design and manufacturing.
- The device would need to be inexpensive to produce while creating the best profit margins for practitioners attempting and/or being educated to treat TMJD

The NiteBite® was born from these considerations. The research and development cycle of design and manufacturing began.

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NiteBite is in the news

Have you heard about Nitebite, our revolutionary night guard product? Of course you have! But are you sold on the product yet? Well, if you need more evidence check out NiteBite in the news.

Click here to read about NiteBite’s biggest advocate

Click here to see NiteBite at Greater New York Dental Meeting 

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