LumiCare™ Caries Detection Rinse

LumiCare™ Caries Detection Rinse is currently pending 510(k) Clearance by the FDA. We hope to serve our communities as soon as possible, but we cannot sell or take purchase orders until we have FDA Clearance. Thank you for your patience.

GreenMark Biomedical Inc. is a Michigan-based, minimally invasive healthcare company founded in 2016. In partnership with collaborators at the University of Michigan, GreenMark has developed LumiCare™ Caries Detection Rinse, an aqueous oral rinse that uses proprietary nanoparticles to illuminate early carious lesions in teeth using a simple dental curing lamp. It is designed to enable dentists to preserve teeth through early detection and treatment. GreenMark’s mission is to expand upon this nanotechnology platform, further applying it to dentistry and medicine.

The Problem

Caries is the world’s most prevalent chronic disease, affecting over 95% of Americans. Detecting small carious lesions can be a challenge using common methods: visual/tactile inspection and X-Ray radiography. The visual exam misses lesions, particularly early non-cavitated carious lesions, and the sharp metal dental explorer can cause damage (cavitation), while with X-Rays we cannot see lesions in our teeth until they are well advanced. While several alternative methods have been developed, they require additional equipment, are expensive, and do not offer significant additional benefit over traditional methods. Therefore, these alternative methods have not been widely adopted by dental clinics.

Detecting the Early Stages of Caries

LumiCare™ Caries Detection Rinse represents the avant-garde of preventative dental care. The LumiCare™ rinse is a water-based solution containing patented fluorescent sub-micron starch particles that have been functionalized to target and adhere to the subsurface of early-stage carious lesions after penetrating through surface porosities. Carious lesions are illuminated with the use of a suitable blue light and can be seen using an orange filter that enhances visualization of the lesions.


Early Lesions Illuminated with Dental Curing Lamp Tooth viewed through orange glasses using a standard dental curing light, after a 30 second application of LumiCare™ Caries Detection Rinse, followed by a 10 second rinse with water; thus, only subsurface carious lesions illuminate quickly identifying porous pre-cavities.


The starch particles in the LumiCare™ rinse specifically target caries, including white spots and porous sub-surface lesions in enamel, illuminating them well before cavities form. The LumiCare™ rinse is applied via a 30 second mouth rinse, followed by a 10 second water rinse and a quick air-dry using the air nozzle. The positively charged starch particles in the LumiCare™ rinse are attracted through electrostatic driving forces into the patient’s porous enamel, which our research has shown is negatively charged. These particles are activated by blue light, using a dental curing light, and dental professionals can then discern between healthy and affected/diseased enamel by viewing the oral cavity through an orange colored lens.

See the Instructions-For-Use (IFU) for further details Using the LumiCare™ rinse, dental professionals can identify dental decay like never before. As a result, dental professionals can recommend improved dental care, use dental fortification products, and actively track patient oral health. LumiCare™ Caries Detection Rinse is made from starch grown by US corn farmers, and it is safely degraded by natural enzymes in our saliva by the time the patient leaves the dental clinic.

LumiCare™ Caries Detection Rinse Provides:

For Patients:

  • Quick and inexpensive access to preventative care
  • Improved dental experience

For Dental Professionals:

  • Greater patient satisfaction
  • More organic referrals
  • Higher case acceptance rates

For the Dental Industry:

  • Continued emphasis and development of preventative and non-invasive care
  • Potential to activate huge market of patients who do not currently see the dentist (~200 million Americans in 2017)

Minimally Invasive Dentistry and Why

Did you know that the American Dental Association (ADA) reported approximately 200 million Americans did not see a dentist in the past year? (Read more information here) The Primary Reasons: Cost and Dentophobia. Minimally invasive dental care is a sea change movement in dentistry, which addresses these two issues while also providing superior patient care.

Minimally Invasive Dentistry is a philosophy and practice that oral disease does not always need to be treated by surgical means. GreenMark is helping dental clinics become less invasive through its development of detection and treatment product, and can facilitate non-invasive care regimens.

Better hygiene practices, preventive techniques and non-invasive products lead to better long-term patient health outcomes. The need for this has been featured in prominent trade journals and academic papers (see references below).

Minimally Invasive Dentistry is enabled when oral healthcare professionals focus on early disease detection, treating the disease while it is still in its infancy, and curing the disease instead of merely addressing symptoms. This represents dentistry of the 21st Century and will help drive more patients to those dental clinics that embrace it.

LumiCare™ Caries Detection Rinse is a key enabler for the minimally invasive dental practice regimen that is centered on:

  • Early disease detection (well before cavities are formed)
  • Non-invasive treatment strategies
  • Usage of preventative products and techniques
  • Patient first practitioner mindsets & technological advancement

References

  1. Gomez, J. Detection and diagnosis of the early caries lesion. BMC Oral Health 2015; 15 Suppl 1: S3.
  2. Zero, D.T., et al., The biology, prevention, diagnosis and treatment of dental caries: scientific advances in the United States. J Am Dent Assoc, 2009. 140 Suppl 1: p. 25S-34S.
  3. Fontana, M., Zero, D.T., Assessing patients’ caries risk. JADA 2006; 137(9): pg 1231-1239.
  4. To help manage illuminated carious lesions as deemed clinically appropriate, applicable clinical practice guidelines have been published by the ADA. Slayton, et al., “Evidence-based clinical practice guideline on nonrestorative treatments for carious lesions” JADA. 2018, 149 (10): 837-849.
  5. Fontana, M., et al., “Non-Restorative treatment …” see image below.

Pipeline Products

Enamel treatment:

  • This Rx product utilizes the same targeting mechanism as the LumiCare™ rinse, but instead delivers fluoride and the essential minerals, calcium and phosphate, that are depleted as a result of dental caries into the porous sub-surface lesion. This product would deliver these minerals directly to the tooth for cosmetic, restorative, and therapeutic applications.

Saliva detection:

  • GreenMark Biomedical Inc. has partnered with Fishburne-May LLC to develop and provide access to the Fishburne™ Saliva Detection Tab. These tabs are an elegant and much-needed improvement in the ability to detect a patient’s ambient saliva volume throughout the day.
  • Xerostomia, also known as dry mouth, is insidious and when left untreated it can lead to caries, gingivitis, periodontal disease, infections and restoration & treatment failures.
  • An oral exam can reveal symptoms, but by the time a patient presents, damage may already have incurred.
  • Many patients with dry mouth report they feel fine, as about 50% of saliva must be lost to perceive dryness, but damage begins much earlier.
  • Dry mouth is one of the leading causes of dental caries in the elderly. Without the restorative properties of natural saliva, people with dry mouth suffer from an increased propensity for dental decay. This problem is growing as medication becomes more prevalent in our society, especially as the average age of the global population increases, with one third of commonly prescribed medications causing dry mouth.
  • The Fishburne™ Saliva Detection Tabs are inexpensive and provide quick & easy real-time readings.
  • The current standard for diagnosing dry mouth includes drool cups and salivary gland cell biopsy, neither of which are a pleasant experience for the patient. The Fishburne™ Saliva Detection Tab provides diagnosis that is quicker and much more patient friendly than current standards.

Xerostomia treatment:

  • This patent-pending Rx product utilizes the same starch nanoparticle platform technology, but instead is being developed to provides moisture, pH buffering and optionally to deliver medicaments directly to the salivary glands.

Targeted anti-cancer drug delivery:

  • This longer-term patented Rx product is being developed with a unique targeting mechanism, designed to deliver much lower therapeutic doses of anti-cancer drugs directly to the site of cancerous cells. This technology represents a potential breakthrough in the capability to deliver anti-cancer medicaments to cancerous cells with lower therapeutic dosing and reduced side effects.