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Professional News Articles : : ON PRACTICE MANAGEMENT by Janyce Hamilton : Caries mouth spray part of new cavity risk assessment and treatment system

Caries mouth spray part of new cavity risk assessment and treatment system

November 5, 2007

“Cruising at 35,000 feet, and she’s fighting cavities” is the caption next to a photo of an attractive woman and a new product, CariFree Boost Antimicrobial Moistening Mouth Spray (Oral BioTech, Albany, OR). The four-color ad card is clever because few people are comfortable in airplane lavatories, so tooth brushing isn’t an option. But, since I had never heard of the spray, it was time to check out who makes it, why it supposedly works, who sells it, and what to tell your patients, should they ask about it.

I decided to interview V. Kim Kutsch, DMD, the CEO of Oral Biotech and CDM Dental, and in private practice in Albany, OR (Kutsch & Renyer), and then also a private practice dentist in the Chicagoland area who is offering it to his patients, Dino Mantis, of Wilmette.

The Interview

Janyce Hamilton (JH): What is CariFree?

Dr. Kutsch, Oral Biotech: CariFree is a new system developed to incorporate the minimally invasive principles of caries risk assessment into a complete system that offers dentists and their patients the ability to treat the biofilm disease that causes cavities. The traditional approach of just drilling and filling cavities reduces pain and restores the teeth to function, but it does nothing to treat and stop the disease process. Consequently, many patients experience a never ending cycle of decay. The CariFree system includes patient education materials, a caries risk assessment form, a biofilm screening test, a biofilm culture, short term Treatment Rinse and longer term Maintenance Rinse, a pH elevating Boost oral spray and a Fluoride Varnish.

Dr. Mantis, private practitioner: To a new patient, I say that CariFree is a proactive method for cavity prevention. On one hand, it’s a test that assesses a patient’s proclivity for cavities. So I tell them the risk level. If they read below 1,500 on the bacteria count, I say they don’t have to worry as much. If it’s over 3,000, that’s in the red territory. Most people don’t know that acid-producing bacteria are genetic, so you can take very good care of your teeth and it won’t stop the cavities. You need to reverse the affects of the bad bacteria, and that’s the second aspect.

On the other hand, CariFree is a mouthwash, so it’s not hard to use, and it’s on the upper end of the pH scale. I tell them, ’you can floss and brush and rinse, and eat healthy, but nothing is going to prevent cavities like this.’ Then, I sit them down and ask how important their teeth are to them. If they say ’very,’ I say, ’then you’ll want to have this product in your cabinet.’

JH: When/how was it discovered/developed, and what kind of patient will try it?

Dr. Kutsch: The CariFree system was first developed in 2003 with the direction of two clinicians, (myself) and Graeme Milicich of Hamilton, NZ, and a dental school professor, Doug Young from the University of the Pacific in San Francisco. It has been market cleared by the FDA and available for sale for two years. The system was designed based on the growing body of oral biofilm research that has been reported over the past two decades. The principle developers studied the available science and designed a system of products based on the best science. Then they spent a good deal of time creating a system that could easily and successfully be integrated into daily practice, meeting the changing standard of care needs of the dentists and providing predictable treatment outcomes for patients.

Dr. Mantis: The typical patient who’s most interested in CariFree is the person who eats well, brushes twice a day, and follows all the rules; yet, they’re still getting cavities. It’s one thing they haven’t tried, so they’re more willing to give it a shot. When they see it works, I don’t have to convince them anymore. But in reality, every patient wants this. They say, ’you mean to tell me there’s a way to prevent cavities and all I’ve got to do is swish it around in my mouth?’ Yes, that’s it; and it’s $80 for a treatment kit. Compare that to multiple visits to an office for fillings.

JH: What is the science behind it, and how quick are the results?

Dr. Kutsch: Currently major scientific studies on the CariFree system are underway at Oregon Health and Science University (OHSU), Portland, and Griffith University in Australia. At OHSU, the study being conducted is measuring the accuracy of the CariFree CariScreen ATP test, and its correlation to bacterial load, cariogenic bacterial levels, and the patient’s caries risk level. This study (“Measurement of ATP Bioluminescence from Oral Bacteria Contained in Dental Plaque: Basic Sciences and Clinical Assessments for Testing of Caries Risk” by Drs. R. Sauerwein, J. Kimmell, T. Finlayson, S. Fazilat, P. Pellegrini, I. Kasimi, D. Covell, P. Gagneja, J. Engle, K. Kutsch, T. Maier, and C.A. Machida , representing [not in corresponding order], Department of Integrative Biosciences, Academic DMD Program and OCTRI Research Fellowship Program, Department of Pediatric Dentistry, and Department of Orthodontics, School of Dentistry, Oregon Health & Science University, Portland, and Oral Biotech) was recently recognized by OHSU for its Innovative Showcase of top research projects at the university, and the only one picked from the dental school. The study being conducted at Griffith University in Australia is a 500 patient clinical trial of the effectiveness of the CariFree rinse products on cavity reduction. This study is currently underway and being conducted under the direction of Kerro Hallett, Associate Professor of Paediatric Dentistry at the University. Griffith University is located in Gold Coast, Queensland Australia.

Dr. Mantis: The system works right away at combating tooth decay. The moment I apply the treatment at the office, it goes to work against the acid-producing bacteria. All patients have to do is stick to the daily maintenance wash to keep the bacteria away. The system also includes an after-meal spray that reverses the affects of food immediately after consumption. Let’s say you have a soda and sandwich for lunch; you spray the CariFree right away and you don’t have to worry about the bacteria festering in your mouth for hours.

JH: Which dental schools are trying it, and what do they think of its formal caries risk assessment concept?

Dr. Kutsch: Currently we have a number of dental schools in different stages of integrating the CariFree system into their clinics. These schools include: UOP, OHSU, Ohio State, Loma Linda, and UCSF. In addition we currently have trials started with DentiCal and also the Indian Health Services.

Caries risk assessment is both an index, or score, to measure the patient’s current caries risk status and also includes their history of cavity development over time. Caries risk assessment is recognized as standard of care in almost all U.S. dental schools, the ADA Council of Scientific Affairs has established the caries risk profile guidelines, and the caries risk form that CariFree uses was developed by Dr. John Featherstone, an internationally recognized leader on the subject, and he validated the questions on the form in two clinical trials.

Caries risk assessment is rapidly becoming standard of care. Almost all dental schools now teach it as standard of care. It is recognized and recommended buy the ADA, is being incorporated into the Western Regional Board Exam. The ADEA has also created a caries risk assessment committee which, if it exists for three continuous years, will become a section and will be a required part of accredited curriculum for U.S. dental schools. The marketing for this philosophy of care and the CariFree system in particular is progressing slowly, while the information and requests for information are growing rapidly. One of the largest dental journals is considering reformatting their journal to reflect this rapidly growing topic. Currently there are hundreds of U.S. dentists and hundreds of foreign dentists performing caries risk assessment and using the CariFree system, and this number is growing.

JH: Why can’t I just keep using the six-month fluoride gel my dentist gives me after prophylaxis?

Dr. Mantis: For one, the CariFree treatment is designed to be supplemented with daily maintenance. Fluoride gel, when applied after prophylaxis, is a noble attempt to fight dental caries (which cause cavities), but it doesn’t go the extra mile. What CariFree does is first recognize the problem (by taking a bacteria measurement), apply an immediate solution (via treatment in the office), and continue to fight the bad bacteria (at home, every day). One advantage of fluoride is that it promotes the remineralization of your teeth, but it doesn’t continually fight the bacteria like CariFree. In general, if you don’t want cavities, fluoride gel isn’t enough—it’s a start, but CariFree is the finish.

Dr. Kutsch: The fluoride treatment you receive every six months is designed primarily for remineralization and protection of the enamel from decay, but it really isn’t directed at treating the biofilm disease. They are generally acidic applications designed on science to drive fluoride atoms into the enamel by demineralizing a little enamel. This doesn’t really address the bacterial make up of the biofilm. In addition, current recommendations from both the ADA Council on Scientific Affairs and the California Dental Association include using a much stronger Fluoride Varnish at the end of the prophy appointment, and there are scientific studies that demonstrate an increased benefit up to four times per year from this procedure. Current scientific studies are also very clear that the cavity causing biofilm disease is not a result from sugar, but rather from the acid produced by the sugar. The extended periods of acidic or low pH conditions in the mouth result in a shift from healthy bacteria in the biofilm, to primarily cavity causing bacteria. The CariFree products are designed to be antimicrobial, attacking the cavity causing bacteria, and also to improve the pH back to normal levels and enable the healthy bacteria to return to control of the biofilm, and also have fluoride for remineralization effects.

JH: Dr. Mantis, what results are you seeing in patients to whom you have prescribed CariFree?

Dr. Mantis: I measure the bacteria levels in my patients at each visit. For patients that adhere to the daily routine, the caries rate is consistently lower. I’ll know if someone isn’t using the Maintenance Rinse every day if their levels persist. I’ll know, too, since they always have a guilty look on their face when I ask them if they’ve been rinsing every day.

As always, I’m excited about employing the latest research and technologies for the betterment of my patients. I continue to learn and teach from the greatest dentists of our time and love to bring that knowledge to the patient chair. As my practice continues to grow, I plan on taking preventative dentistry to the next level, where two trips a year to the dentist are all that patients need. Using the latest products and devices, such as CariFree and Diagnodent (a laser that detects cavities with 90 percent precision - better than X-rays), I think I can accomplish this.

JH: Will CariFree over be OTC product or only dentist-dispensed/place product?

Dr. Kutsch: Technically the oral care portion products in the Carifree system qualify for OTC products, but we feel strongly that patients need to be educated, and monitored during any caries treatment. So we have made a corporate decision to keep CariFree products as only dentist dispensed.

JH: Well, last question is for Dr. Mantis. Do patients ever complain or refer?

Dr. Mantis: Overwhelmingly, the response is positive. The only complaint I’ve ever received from people is that the taste of the A&B two-week program rinse is less than desirable. As for the results, nobody has complained. Before they try it, you have your skeptics who aren’t used to preventive dentistry. They only believe it once a drill goes through their teeth. They may question the effectiveness of a swab and mouthwash, but when they see it works, everybody’s happy. I’ve gotten a number of referrals from patients; some who aren’t in the Chicago-area but scramble to find other dentists who administer CariFree. Though you still have to have good dental hygiene, I find the system to be very effective in generating positive word-of-mouth. As long as patients exercise awareness in diet and hygiene while using CariFree, the word-of-mouth popularity will continue to grow.

Conclusions

The idea of microbial homeostasis in the plaque/oral biofilm-including raising the pH above the 5.5 “demineralization zone” is not new, but few manufacturers have tried such a comprehensive approach to managing the oral environment to discourage bad bugs from ruling.

Watch the studies as they emerge to see where this is going.

Oral Biotech offers a starter kit to dentists (under $3,000 the CariScreen Caries Susceptibility Testing Meter, testing swabs, Fluoride Varnish, Treatment Rinse, Maintenance Rinse, Boost mouth spray, brochures, Caries Risk Assessment and Corrective Action forms for screening 100 patients and treating 24). For information 1-866-928-4445 or www.CariFree.com.

Janyce Hamilton is an award-winning Chicagoland freelance dental writer and editor. Send suggestions for topics to be covered, or any comments on this column, to review@cds.org.

Copyright 2007, Chicago Dental Society