Transcribed by Albert Cheng 9/12/14

[DOD Cariology] [Lecture 31] – Selection of Dental Materials for the Management of Caries by Dr. Wolff

Slide 1: Strategies for Preventing DecayThank you for coming down and listening to the presentation. An interesting thing struck me around this time yesterday. I was in New Delhi actually giving a lecture on Arginine toothpaste and changing/modifying the flora. The thing that was most remarkable to me was that we had over a thousand people in the room at the time coming in to listen to what I considered a much worse lecture than I spend time giving you folks. They travel from around the world to attend the meeting. They paid very big money to see me do the presentation…not quite as much as you guys pay but for the rest of you that are doing this from home…I don’t get it…not having the opportunity to ask questions not listening to the presentation live. Take a home correspondence course. This is for people listening. You people…thank you very much for attending. As a result of that you have 6 more minutes to download the presentation. Presentation comes down in the next 6 minutes. Download them…otherwise they’re just hanging out. They are copyrighted items, you’re not allowed to distribute them. If I find out a student distributed them, I will be all grumpy and aggravated and you don’t want to see me grumpy and aggravated. If you happen to be in attendance and not have your computer with you, feel free to email me…I’ll do it on a personal basis. So there’s two items we’re going to talk about today. I changed my presentation today because Billy he asked a question of me and I sent him five journals and it was very interesting to me that for some reason some people in the class are sitting there and questioning whether fluoride varnish is an effective mechanism for controlling tooth decay because somebody discusses in a case presentation (SAPL) article that said fluoride varnish doesn’t work. So I’ll post the same five articles that I sent to Billy. One is the most recent Cochrane review…one is the ADA review and what these articles are are not expert opinion article…they’re actually review of the literatures and studies. So when you reread this, you realize that you know several tens of thousands people have been studied in caries management using fluoride varnish as an intervention. It’s not rumored that it works…it actually works. Billy asked an interesting question, “what’s the school policy on fluoride”. And I responded quickly, there is no school policy on it. But if you’re asking what we teach and what we do in the clinical environment, youll hear from me and you’ll hear more from Dr. Allen later on next week…discussions about how we manage high caries risk patients with fluoride varnish, take home fluoride and that management. I’ll tell you that a fluoride prophylaxis paste does nothing but a fluoride varnish/gel is better than no fluoride at all. Fluoride varnish today has climbed to the king of the mountain as far as dentist applied preventive increment management. We’ll talk about that today. Then we’re going to be talking about something that’s very important to me and that’s managing oral health in an aging population. It’s important to me because one of you may be stuck taking care of me in my geriatric life. I need you to understand how to do that well because that day is coming. On the other hand, I do have someone genetically that I put responsible for taking care of my teeth when that day comes. Taking care of old teeth isn’t the same as taking care of young teeth. We have to make ugly decisions. You have to decide to restore or don’t restore this tooth. What do

you do with somebody when they were 55…they were the king of Wall St and put 25 units of crowns/bridges in their mouth…now they’re 85 years of age and they’re starting to get recurrent caries around the outside of it. How are you going to manage that patient? They don’t have another 100k to throw at their mouth at that time. You have to come up with good appropriate strategies for managing that and we’ll speak about those. We’ll talk about strategies for managing decay.

Slide 2 – Graph (Age-Specific Mean DMFS in Three National US Surveys)This is a really neat graph. 1971, you were looking at 15 surfaces of caries in the average 16 year old. Today, you’re looking at something just over 5. And the big event that took place was in the 1950s, fluoride toothpaste came out…fluoride showed up in our environment in terms of a water supply and we saw a change in the way we approach tooth decay. It went from inevitable that you were going to get it to a manageable item. And the inevitability came out of actually the fact that every time we counseled you to eat less sugar, it never worked because you could never eat enough sugars to stop tooth decay. You happen to be chewing on xylitol containing lollipop. Each lollipop contains 2mg of xylitol. You need to get between 8-10 mg of xylitol a day to get an anti-caries effect. You get to 20-25 mg a day…you have a diarrhea effect. So don’t get addicted to these things. But this all goes towards a management strategy. Can I prevent decay on a patient that’s not getting decay? So if I am a low risk patient, no matter what I do, I can’t reduce the risks of caries. And that’s the reason why they took fluoride treatment away from adults as a paid benefit on most insurance. Because dentists do some things by rote, we take a young child…they come into the office…they never had a cavity and we say to them…ok we’re going to polish your teeth which by the way does nothing in the long term…it may take off some stain but does nothing…we can give you OHI…we can check for caries but that prophy…48-72 hours later…sorry no difference and then we do a fluoride treatment on that child. Now that child doesn’t have fully formed teeth…has moderately controlled diet and has been relatively untested. We can make the good case that they’re at some risk levels greater than zero. But when you got 35 years of experience and you come into my office, I sit you down in the chair and you’ve never had any cavities in your mouth, the question is can I reduce the likelihood of you getting decay by putting fluoride varnish on your teeth 2,3,4 times a year? You weren’t getting decay before, I can’t make you get less decay than no decay. So for that reason and the fact that dentist were not doing this on a risk assessment basis, they said take this benefit away. We can make the case that a 16-17 year old child has risk…we’re having trouble making the same risk for the adult. I’ll tenured to you that even in the young child if we did a better job of risk management we could reduce the expenditure on fluoride there and increase the fluoride level on somebody who’s getting radiation therapy for instance. To me it’s a crime, we can’t get paid by Medicaid…you’re getting head and neck radiation, you’re on drugs that cause xerostomia…your risk is super high of getting caries and there’s no way of us getting compensated for it…that’s a real problem. So we need to learn to control that. And today there are some states that are just starting now (California) to pay dentists for doing risk based management. We’ll pay for adult caries if you do a caries risk assessment. And what they say is prove it to me. So if you want to do a periodontal scaling on an adult, your insurance company says send me the probing depths and we’ll let you do a SRP. Well now in California, they’re hoping that they’re

going to say send me the caries reisk assessment. You’re going to say the patient is taking xerostomic drugs…they’re getting head and neck radiation…they have Sjogren’s syndrome…any of the things that we taught you about that elevate your risk. That’s why we’re teaching risk assessment to you so carefully at this moment. So tell me about sugar consumption at the same time. Between 1950 and today, what’s happened with sugar consumption? It continues to rise. So the sugar industry has actually used this exact same graph and say you see sugar doensn’t cause caries. Sugar consumption has nearly doubled when we take high fructose corn syrup and sucrose and put it together as a category. If we take that category and melt it together and go look at this caries risk stuff, they say you’re consuming more and you don’t get caries. What they didn’t take into account is that we went from no fluoride in the national equation during 1955 to virtually 80%...almost 90% of the population uses a fluoride toothpaste. 60% of the population lives in fluoridated water areas. Fluoride has entered our equation here. It becomes a different discussion as to whether or not as a public measure…do I need you drinking fluoridated water? [student answers….No]Probably not on a couple of reasons. Tell me why he probably doesn’t need it. He’s educated, we can talk to him, he brushes with fluoride toothpaste. What’s interesting about fluoride as a public health item in the water is it’s targeted at population that not everybody needs it. Not everybody needs a polio vaccination. When we look at it as a whole as a society, we see benefits to it. So the very young, aged, and underaccessed group all get benefits from using fluoridated water. So all of us end up drinking it as a part of the process. And that’s an interesting item. So when people say to me do we have to fluoridate the water? The technical answer is we don’t have to but it serves a positive incremental benefit

Slide 3 – Fluoride is the 13 th … Let’s talk about fluoride. 13th most abundant element. Fluoride is an element that’s been always will be a part of the Earth’s crust. It’s found in certain rocks at very high concentrations. As a result of that, what we need to know about fluoride is that it’s found in saltwater and certain waters that run over these rocks that have high levels of fluoride in it…those water wind up with very high fluoride levels. So as we go to certain areas of the country particularly the American Southwest, northern Mexico, parts of India/Asia…they have very high concentrations of fluoride…that’s actually where fluoride came from.

Slide 4- Fluoride Reduces Caries by:[Wolff] – Fluoride reduces caries by a couple of ways. It’s incorporated into the tooth as it forms, causing fluoroapatite to be formed. We talked about that. It reduces solubility. Its biggest effect turns out, it’s probably incorporated into the outside of the tooth or into our plaque. As we brush, it stays there and causes these fluoride containing moieties, probably not fluoroapatite, but a less soluble fluoride moiety in the outer surface of the tooth that reduces the tooth from getting decay. The last is the one that Dr. Caufeld loves to address – this is the inhibition of the S. mutans amylase reaction by fluoride which unfortunately require a high level of fluoride which by the way if we look at plaque and if you have lots of fluoride on the surface of the tooth and you get an acid attack, we get certain amount of hydrofluoric acid made that negatively affects those bacteria and we

see the amylase reaction interfered with also. Certainly, when we place fluoride varnish on the surface and we repeat it, we do see some antibacterial effect.

Slide 5-Fluoride (1930’s)Fluoride was an accidental discovery. His name was Robertson (he couldn’t remember and rambled on)…he was a wonderful epidemiologist in Colorado that actually saw people with ugly brown mottled stained disgusting teeth in the 1930s. What he noticed at the moment was that none of them had decay. These were ugly puppies in there but they weren’t getting cavities. And when he started looking around, the one thing that showed up all the time to him was high concentration of natural endemic fluoride. So these patients had fluorosis and we’ll go through what fluorosis is in a moment. These patients had fluorosis but didn’t get decay, it dawned on him. He started looking at fluoride levels in the water supply and started looking where tooth decay was occurring. He never found fluorosis when fluoride levels were 1ppm and that became the magic number. All of the sudden, everybody said let’s go with 1ppm. That’s going to be the public fluoride level and we’ll see reductions in tooth decay. The study was never done to see whether we get as much tooth decay in 0.5 ppm as we do in 1 ppm. The actual fluoride levels…I took those slides out…are determined by how much we actually drink. So in warmer areas, you have lower fluoride levels so your per day exposure remains the same. When you’re further North in the latitude and you’re cooler, you drink less water which are suppose to be at higher concentrations. It’s a very interesting concept and it was all a guess! None of it was actually in a real scienctific realm in terms of does this work better than this. So we came to 1ppm and today the recommendation has dropped to 7.7ppm. And that has been done purely as a method of reducing the untold effect of fluorosis. The untold effect of fluorosis is not the ugly mottled tooth that I was talking about. It’s a very light white haze on the tooth. We’ll go over it in a moment.

Slide 6- Fluoride (Grand Rapids)So Grand Rapids in 1945 ran its first study. They decided that they were going to optimize at 1ppm. Today 62% of the population is in fluoridated communities with 10 million in naturally fluoridated. High fluoride concentration is very hard to get out of the water. So in those areas that have naturally occurring water at much higher concentrations, they do a lot of thing including blend non-fluoridated water in it. It’s very hard to get out of the water in that respect. Fluoride still becomes a controversy. You see it all the time. In recent years, people have said yes more frequently than take it out but as a public health thing, we asks our dentists to be very conscious of understanding that there’s still today a giant population that needs fluoride in the water. Now there’s a lot of anti-fluoridation stuff. If you look up fluoride on the internet, it’s going to show up and it’s going to show that it concentrates in the pineal gland. Nobody’s ever seen any negativities out of it…that it’s associated with osteosarcoma. Great Harvard study on osteosarcoma looking at concentrations ranging from those very high concentrations in the Southeast to very low or no fluoride in water, the rates of osteosarcoma and arthritis are the same. Every study that actually looked at this subjectively has been unable to find anything related to the public fluoridation concept. So there are still people that still do not vaccinate their children and do not go through that public health measures of prevention because they feel that there’s something. But the truth is we have to come

back to the science and ask is there real science that shows that we’re causing any problems by putting into the water supply. There’s just nothing in the science that pops out

Slide 7 - Community FluorideSo what’s really interesting is that I come from Long Island and I can’t find it, I meant to get it to put it in but Newsday didn’t exist. It was the local newspaper in the 1950s that was talking about doing water fluoridation in the LI community. The headline was “Communist plot to put fluoride in the public water supply” and I thank them because it keeps my practice running really well…that very wealthy people who don’t put their children on fluoride supplement vitamins and things like that which we don’t do here in the city but we do in suburbia where there’s no fluoride. If we don’t supplement the kids with fluoride, they get cavities. I see it at my practice all the time – lower fluoride rates, higher income rate for me.

Slide 9 – Water FluoridationWater fluoridation depending upon who you read, 40-60%. So in a population that’s actually brushing with fluoride containing toothpaste, I need you to understand the nuance that it’s probably not nearly as high as a result of the water fluoridation. Cause fluoride toothpaste has a tremendous increment of tooth decay. I can’t take toothpaste which gives you 40% and water which gives you 40% and put them two together and say 80%.

Slide 10 – FluorosisFluorosis is this condition of excess fluoride. Excess fluoride has been described all along as this event that causes fluorosis and it’s a very interesting discussion. While I was in India, I met with corporate president and the minister of health from the Philippines who they brought to the meeting and we’re going to do the Grenada plan in the Philippines…they signed off on it while we were there yesterday. It was a very productive day for NYU…but back to where we were. One of the big discussion that took place in Grenada was how are you taking these kids and letting them swallow the toothpaste. What happens when they get fluorosis? So can you get fluorosis when you’re 17 years old by taking too much fluoride. You said no very quickly…it’s correct. Give me a reason. Fluorosis causes the crystals not to form properly. High concentrations of of fluoride, you cant get the HAP crystals to line up properly. It causes this mottling inside so we get this malformed tooth that takes place. I cant get fluorosis on a senior citizen that I’m giving fluoride varnish to once a week to prevent decay. It’s not gonna happen. So that’s the first thing you gotta dispel. When you’re 6 years old, you’re done getting fluorosis…maybe the gingival margin of the canine is still forming enamel but the tips of the canine are all formed. So the concept of fluorosis from over fluoride exposure…my nephew has this white mottling on his teeth…he’s now getting ready for medical school and my sister who’s very bright…who knows more about medicine and dentistry than any dentist could possibly know…she just reads this stuff and learns it. She comes to me and says why does Jonathan have these white spots on his teeth. I said he’s probably eating his fluoride toothpaste. And she’s a highly defensive mother, her son is perfect in every way. So she looks at me and say it can’t be that…he wouldn’t eat the toothpaste. Jonathan was 13-14

at the time and his teeth were erupting and he was sitting in my dental chair and we were talking about this and Karen (his sister) goes to defend him and Jonathan said I love the way toothpaste and I still eat the toothpaste…I never swallow this stuff. That’s where the recommendation has come…that young children until they can spit out toothpaste shouldn’t be brushing with any quantity of toothpaste…you might put a little smear on it for flavor…and then I love the toothpaste AD company…they teach you how to put toothpaste on. How do they teach you to put toothpaste on? Yea cover the whole head of the toothbrush. That is done because they sell toothpaste for a living not because they protect you from getting cavities…you don’t get anymore protection out of it. So we have an issue teaching people how to use toothpaste correctly. In Europe, 1500 ppm toothpaste are the norm. They teach people how to use it. They say there’s an adult toothpaste and a child toothpaste. You’re a child you get 900-1000 ppm. You’re a grown-up you get 1500 ppm. They see an incremental difference in tooth decay prevention. In the US, we’re not as sophisticated as saying this is the child’s toothpaste, it’s going to have a lower concentration and this is an adult’s toothpaste it’s going to have a different concentration. So we only come with this one concentration of toothpaste that’s as high as 1400 ppm and as low as 900 ppm but we don’t buy toothpaste specifically for higher or lower fluoride content. But we do talk about now…small smear for the child, small pea size. The reason is, on the forming tooth, you want to control the amount of fluoride a child gets. Now a research project with this student at Stony Brook, we wanted to look at other sources of fluoride. So we started looking at foods. It turns out apple juice, depending on the brand, 3 ppm fluoride content. And that’s because, it’s very simple, if you look at the labels it’s from concentrate. So they take gallons of the stuff they concentrated and they reconstitute it back and they don’t reconstitute it back thinking about fluoride. This Diet Coke depending upon where it’s bottled comes with fluoride in it because all of the water filtration system don’t do it. When you buy food in a can that has been boiled, the concentration of fluoride in there can be…as a result of that, we saw an increasing level of fluoride almost endemically in our diet that’s been fed to children. And that’s the reason we’ve seen this discussion about lowering fluoride levels. And I give this to you in a sophisticated manner because you need to be able to discuss it with your patient when they start to question, “why do I have to do a smear”. It wasn’t that we’re afraid of the toothpaste. All of a sudden, fluoride started showing up in other areas that didn’t make the toothpaste bad but made the toothpaste additive on top of the load that the kid was already getting. Once he gets 7 years old, all his permanent teeth are essentially formed and everything that’s visible is there. If his 2nd molar had some fluorosis, it would be to your advantage because it would have less caries in it.

11 – Mild Fluorosis (picture)Very subtle white, even more subtle than this (pointing at the white spots on the tooth). When you see a white spot in one spot on the tooth, can that be fluorosis? ABSOLUTELY NOT, you find fluorosis runs in bands or in waves over large areas of every tooth that was forming at that moment. So on a lateral incisor, it might be at a different height than the central incisor. This child was getting higher fluoride concentration when those teeth were forming, which started at birth to age 2 probably…that incisal edge and you would see the band elsewhere the same way you would see band from tetracycline.

12 – Severe FluorosisI don’t have any good fluorosis picture because we don’t get really good fluorosis. This comes out of a textbook. But you can actually see, it can be so bad that the tooth doesn’t form properly.

13 – Fluoride: How Do We Deliver ItSalt, this is the major way that the WHO looks to bring fluoride to underserved communities because salt is heavily consumed. We have issue with salt on a couple of levels. Salt fluoride has the difficulty we don’t know how much someone is going to use. It also has the difficulty…how do I tell someone to use salt now in their diet and when they have hypertension in 10 years…say cut out the salt. It’s a mixed public health message. School water supply…I don’t know anybody that’s doing this anymore. This was a theory that in the 1970s you could bring it into the school and target it directly at the age group that needs it during development. What’s the problem with milk? Lactose intolerant people don’t get it. Give me a problem with putting fluoride in milk. Getting fluoride to function in the presence of calcium is difficult.

14 – Areas of Endemic FluorideWe did this already

15 – Fluoride Recommendations (with chart)I need you to understand that when you’re looking at level of evidence for…evidence from expert committee…I sit on these committee…people consider me an expert on it but my opinion doesn’t matter squat compared to someone that has evidence from systematic reviews and randomized control trials. If my opinion is different from that opinion, my opinion doesn’t mean anything. I have to be a real renegade and really have an understanding of something that nobody else does for my opinion to really mean something. And you need to recognize that… you have faculty member standing up here lecturing to you. When we don’t follow the real evidence table, you have to question whether the expert is really on mark when they say fluoride isn’t necessary. So classification A is the highest. It’s based on Category 1 evidence. 1A or 1B means evidence from at least one randomly controlled clinical trial. You’ve learned about this. If we get the exact right age with the exact right conditions with the exact right everything, we divide it into randomly controlled…we go ahead and look at the exact same outcome on the subject we’re looking for…that’s a very powerful study. If you have one really good randomly controlled study, that actually trumps everything else because it’s directly targeted at your group of people that you’re talking about. So that might be 32 year olds that have Sjogren’s disease on the left side of their mouth….nevermind

16- Fluoride RecommendationsCommunity water fluoridation has been ranked by experts throughout but it is probably one of the big public health measure in reducing tooth decay that has happened anywhere in the world

17 – Fluoride Recommendation (same chart again)I think I have this table in two places. This is professionally applied fluoride. You may not receive additional benefit for a low-risk person. That makes a lot of sense to me. It’s back to my original statement: “I can’t prevent decay that’s not going to happen”. So that’s really simple. But when we look at the high risk person, we see 6 month application or even 3 month application being extremely of high values throughout all age groups except when we get to this older group of people. The over 18…then it falls into that expert opinion. You know why and you have to understand this. Why don’t we have really good clinical trials in this age group? There have been some really good trials that looked at root caries, they’re relatively small. There have been some decent trials that looked at nursing home people, their life expectancy is too short. We do studies in school because we find the children there 180 days of the year. They don’t move around…they can keep coming back and they’ll be there the entire time. We don’t get that with adults and that’s a problem. So the studies just haven’t been run. But we have to ask the question. If you’re a high risk individual, is there anything that comes with your driver license that actually says that you suddenly will no longer have the same effect of fluoride as an adult that you had as a child. So if you were 16 years of age…we have studies that say fluoride varnish reduces tooth decay…you get your driver license….you’re 18 of age...is there something there that says fluoride doesn’t work the same way. That’s where the expert look at the system and say there’s no biologic reason why we shouldn’t be able to extrapolate this but there are caveats there. The caveats are that this is the high risk individual. We come back to the adult with low risk and we keep saying the same things. The experts come back and say I don’t see any real benefit to this. No studies have been run but there’s no reason to believe that the adult is going to performed different than people where the evidence is there…where there’s 1A evidence available. So we recognize this and extrapolate this out…and as a result of that some people have said there’s no evidence. There’s no clinical trials but there’s plenty of extrapolatable evidence.

Slide 18 – What properties would the ideal fluoride product have for Caries managementWe like our fluoride products to work rapidly. We’d like to be able to do things that we don’t need the patient to spend a lot of time on. I could send you home with a high fluoride concentration toothpaste (5000 ppm)…it’s going to be one of our strategies for reducing tooth decay but if I have something I can do in the office once or twice…3-4 times a year and control it…there’s real benefit to that. The clinical studies on varnish have shown it to be more effective than gel. So a whole load of research didn’t happen on fluoride. It didn’t happen because it became successful in what it was doing. So for instance, fluoride gel that are put on the tooth for one minute…anybody work in dental offices… one minute gel for fluoride…how many clinical studies were done that said one minute….ZERO. Not a single study was ever run that showed that a one minute gel worked properly to reduce caries. How did get to a 5 minute gel? This is a real surprise one. The person applying gel would go out to have a cigarette in between each time he put the gel inside the patient’s mouth…took him 5 minutes to smoke a cigarette…that’s how he came to 5 minute. That piece of research never went on as to how long it needed to stay in the tray. We did do various strong research on fluoride varnish which actually

showed that you get good sustained release over several days and actually incorporated well into the tooth.

Slide 19 – Fluoride Recommendations - VarnishFluoride varnish every year, twice a year on high risk patients come with very high levels of evidence. Multiple studies have demonstrated its effectiveness. Two or more treatments in the high risk patient actually turns out to also have very high risk (this is what he said but it doesn’t make sense). One of my schoolmate, who’s actually the Dean at North Carolina (Jane Weintraub), ran this wonderful study with outstanding final results where we saw people that had no fluoride varnish, 1/4 of them had tooth decay. And when we went ahead with 4 varnishes a year, it turns out to be a 2% decay rate. That’s incredible as strong of evidence possible. High risk population…did nothing with tooth paste…if the kids were brushing they did nothing with them other than come in and do fluoride varnish on them 4x a year. That’s very strong evidence in a high risk patient.

Slide 20 – Fluoride Recommendations – Varnish (w/ Figure 1)This is another outcome on 4 varnish application…this is another reading on Jane Weintraub’s study.

Slide 22 – Table 2Pooled estimates…the preventive fraction…46%...very high confidence levels that these things work. Gel you can see has a lower preventive fraction from clinical studies that were run at a little bit lower confidence rate. Toothpaste still has a 24% reduction…that’s pretty outrageous. The OTC rinses…all of those rinses use to be prescription originally…now they’re all OTC…also show a very substantial increment added on. [Student asks question – inaudible] Now comes the real hard part. A great question. You want to know if you can’t add them together, what do you see? When we do studies that look at kids using regular toothpastes and add fluoride varnish to them, you see almost a 25-30% increment on top of that. Now when you go to an area that has fluoridated water and fluoride toothpaste and varnish, you’re probably looking at a 8-10% increment difference. So if you were looking at 10 surfaces of caries that the child was getting originally, you’re probably looking at saving 8 surface of caries which comes to a totally different financial question of do you do this many fluoride varnish treatment to prevent 1 surface of caries…totally different argument. I personally believe you do anything you can to avoid the surgical impact as you go through the process

Slide 23 – CDC Recommendation (Table 4)CDC, their recommendations, high risk patients of all ages…the strength of recommendations once again are all very high levels of recommendation. The evidence drops down as we get to the older populations.

Slide 24 – ADA RecommendationsWe’ve seen the ADA, WHO, multiple systematic reviews all talking about the value of fluoride varnish and toothpaste…all having major effects. I need you to walk away with the concept, it’s not the only bullet we have in the gun but it’s a significant bullet and it shouldn’t be neglected

Slide 25 – Important Factors to ConsiderWe need to understand toxicity when we look at the actual concentration of fluoride that you get.

Slide 26 - Pictures of different type of varnishesThere are lots of different types of fluoride varnish available. I have to tell you some interesting things. When we look at these “vanish varnish” and these other varnishes, they’re starting to introduce calcium into these varnishes as part of the process. So they put MI paste, this calcium phosphate into the varnish. I really worry whether we get a calcium fluoride before we get into the tooth. Very little research has been done to actually prove whether or not adding calcium decreases the effectiveness of the varnish. That’s a very scary concept that so many companies have jumped on top of this all at once. That being said, there’s a very novel varnish which I don’t have a picture of that 3M makes. It’s called “Vanish Varnish” by 3M. It’s a 22000 ppm fluoride with calcium phosphate in it. CaP is very interesting…it’s surrounded by a soap that when you add water to it, it slowly dissolves so that the fluoride gets first entrance onto the tooth and then they put this high concentration calcium and it can drive the mineralization…very novel way of doing it…it’s quite effective. So I’m speaking for 50 minutes so far, can we continue and finish…we’ll be done at like quarter to…everybody ok with that

Slide 27 – A bit of History F VarnishesThe original varnish was these real rosins. Duraphat is the grand-daddy of varnishes. It’s a Colgate product. I remind everybody in the classroom. I am a paid consultant for Colgate. I help invent toothpaste with them and run clinical trials with them. I don’t care whether we’re talking about the Duraphat or any of the other varnishes that are available. I’m kind of looking at them in a generic sense.

Slide 28 – Summary of Duraphat varnish 50 mg/mlIt comes in a high concentration…something almost in the 22000 ppm. They come in various concentrations. They’re applied to the tooth…you don’t want to apply them to globs of thick plaque because that gets washed off too quickly. But it’s actually more effective if it’s on a thin plaque. A little bit of plaque on the tooth retains the varnish little longer and actually results in better mineralization.

Slide 29: Summary of Clinical Studies/IndicationJust a list of studies if you want more references. They’re there as to why and how.

Slide 31: High Risk IndividualsHigh risk individuals should have fluoride varnish as frequently as you can get them in to do. I in my practice actually work and have a recall that my hygienist sees the patient 4x a year at minimum to do fluoride varnish. I do a fluoride varnish on my high caries risk patients every time I do a restorative procedure on them. I charge them 15 dollars…the stuff only costs me 2 dollar a dose. I finish my composite on them…I paint the fluoride varnish. The patients accept it and understand what we’re doing and as long as they stay on the program, we can essentially turn off their decay. It’s when they stop coming back

for that 3 month recall. They come back 2 years later and you look inside their mouth and you go ughhh. There’s an exception to this. My real dry mouth patients…the patients that have either severe Sjogren’s or severe xerostomia secondary to radiation. Because they don’t have as much phosphate available and because there isn’t a liquid media to help move along this demineralization/remineralization process, we don’t see as much success with them. It is the most effective. But then there are products and we’ll talk about that in our last presentation…we’ll talk about these calcium products that can be effective at reducing tooth decay. From a cost standpoint, like I said, 15 dollars is cheap to do…it’s a few minutes of your time…it’s a 2 dollar product.

Slide 32 – Colgate DuraphatWhen you paint it on the tooth, there’s very low ingestion of it. It’s slowly released over the next day as they brush, wear, and eat on the outside of it. Low plasma levels are found throughout. It’s really quite effective.

Slide 33 – Who can apply fluoride varnish?In Grenada, we had teacher and dental assistants. In the US, a licensed professional has to apply it because we’re afraid of…I don’t know. Fluoride is a toxic agent if eaten too concentrated. What’s the antidote for a child that eats a big fat tube of Duraphat varnish, which is why I don’t like using Duraphat. You have to tell them to immediately get to poison control, but what do you do? Milk - get them high concentration calcium as quickly as possible… you try and make CaF out of it which they poop out the other side. You let poison control make the decision or not whether or not to induce vomiting. Vomiting is no longer what they like to do with poison because theyre afraid of aspiration. So that big bottle of fluoride that dentist keep in their office as their gel, that’s hazardous if a child were to go ahead and drink it. It could enough fluoride to be neurotoxic and cause paralysis as part of the process. So it is something that you have to pay attention to. Why did I let anybody apply fluoride varnish in Grenada? Because they came in little packets that when you peeled open the top and if an infant ate the content of that packet, it has no effect on them. Very safe distribution, easy to go do, disposable brush, I didn’t have to worry about infection control. We bent the brush, showed them how to do it without touching the kids lips. I can do 50 kids one after the other without washing my hands…I never touched the child. I touched the very end of the brush and that was all…that’s why we liked that delivery system.

Slide 34: Mode of usage Quick and easyIt’s simple and easy application. You brush it on the surface…stick it interproximally and put the leftovers on the occlusal surfaces…you tell them not to brush for the rest of the day and don’t eat/drink for the next 20 minutes to let it set and harden. It stays on the tooth for approximately 24-48 hours before it’s either physically scraped off or dissolved off. The plaque actually holds it, it contains a higher level of the fluoride in the biofilm. A little bit of acid actually causes a remineralization.

Slide 35: Use of Duraphat Varnish supported by:More sources and if you were in the classroom and actually were able to download that file, you can look those up later on by clicking on them.

Slide 37: States with Medicaid funding for Physician oral health screening and fluoride varnishPhysician are now getting paid to do fluoride varnishes on children. Pediatrician in NY state get Medicaid for putting fluoride varnish. You know why that happen? Dentists didn’t jump up and become the ones that wanted to do this over and over again so we wound up seeing other health care providers fill that void. We need to be real careful about that and a lot of our prevention in the future. This is a big deal. Medicaid covers it all over and they’re still not doing it enough.

Slide 39: Important Factors to ConsiderIt doesn’t etch and stain the tooth. There’s lots of clinical data on it.

Slide 40 – A bit of History F VarnishesDuraphat 1960s. There’s stuff that we use today. It was cleared as a medical device. Do you know what it was cleared to actually treat? Fluoride varnish in the US are on label as an anticaries material. How many people say it is? How many say it’s not? The “NOT” are right. It’s actually not on label as an anti-caries. It’s actually on label as being anti-tooth sensitivity product. That’s pretty incredible. Throughout the rest of the world, it’s on label as an anti-caries material but in the US they never bothered filing it with the FDA

Slide 42: Additional “Active” IngredientsSo the vanish with tri-calcium phosphate is a novel way of doing it. Enamel Pro with amorphous calcium phosphate…a little bit more worrisome for me as to whether or not it actually forms the proper moieties as we go through the process.

Slide 43: F Varnishes Regulation in the USIt is regulated on multiple levels as being safe but not necessarily for caries.

Slide 44: Considering Some of the Important Factors that Affect FV EfficacyWe need to know about the caries activity level…the frequency that we’re going to do it. Let’s skip through this, I’m done with fluoride varnish. [Student asks questions – inaudible] Over the counter, it’s still regulated because…I haven’t had the foggiest idea. I guess you could abuse it. In Europe, you can’t get Tylenol OTC because it can cause liver toxicity. In the US, we’re worried about fluoride varnish. I would much rather put fluoride varnish on the child’s teeth once a week and cause fluorosis in the kid and no caries. When we’re talking about fluorosis, so you have white spots on the teeth versus cavities. I would prefer it being used properly. The ADA very strongly feels that it should be done by a professional. [Student asks questions – inaudible] It’s off label…if somebody died that would be a malpractice suit that you’re using a drug off label. Many drugs that we use are used off label. It’s actually quite interesting…once a product makes it to the market, a company can’t advertise that it’s effective at doing something in the US that isn’t on label. So if you look at all the advertisement, you don’t see anything about any of their varnishes as being anti caries in the US. The rest of the world, it’s more advertised as being anti caries where it’s ON label. So MI paste, which we use for caries

all the time is on label as a sensitivity product. [Student asks “why don’t they fix it”] The FDA doesn’t put label on anything. I as a company have to apply and go ahead and put it on label which means I have to go to the FDA to pay the cost of filing it. So there’s 30 different varnishes available in the US, I would have to pay as my company 3-5 million dollars to put it on label and every other company out there goes ME TOO…I have the same product. There’s no reason for any one company to jump up and invest to get it on label. There hasn’t been a new fluoride toothpaste efficacy study in decades. Everything comes off of monographs. It’s actually what I do as a specialty. I look at toothpaste compound compare it to what the monograph says…say essentially the same…and then I sign off on it as part of the process saying that these are essentially the same compound. FDA takes it from a panel of expert and they say ok it’s an “Me Too” application using the fluoride monograph as a method of putting it on the market and it saves the company multiple millions of dollars. So the minute two ingredients show up there at the same time, you no longer look like the monograph and you can’t do “Me Too” anymore and you have to run the study and that’s why in the US, there are a myriad of dental products that are not on the market here but on the market in Europe. That’s why the Arginine toothpaste is not on the markets in the US. It’s on the market in Europe…just released in India/SE Asia but it’s not going to be in the US market for a number of years because it can’t fit on our monograph. It’ll cost them 15-20 million dollar to put it in the monograph. They’re preparing to do that

Slide 46 – Cariogenicity of FoodSo let’s talk about caries and foods. This is one of the most controversial subjects out there. Can you make a food that’s low cariogenicity? There’s no measure like calorie to say it’s a low calorie food…that’s a problem. We have this high calorie/low calorie. We can’t just look and say there’s 5 grams of sugar here versus 4 grams of sugar…one is higher in cariogenicity than each other. So this becomes a problem on how to run these study especially if that means you have to eat 20 gummi bears a day and you have to eat 20 of these a day, and we have to compare the decay rates on each of you. But there’s so many other factors…how many times a day do you brush, what else do you eat…we could never make this a true in vivo study so it’s a massive process to go ahead and look at cariogenicity of food. There’s a number of different things that go on. There’s some laboratory research that just goes ahead and looks at what the free fermentable carbohydrate available and there’s an assumption that if there’s a lot of free fermentable carbohydrate, it causes acid formation and tooth decay. Most of it turns out to be in vitro or animal studies.

Slide 47: Caries RateWe talked about this…we watched isolated area of Alaska had no tooth decay when they were eating whale/seal blubber but the minute we gave them chocolate bars…(he rambles on about an outreach to Alaska). When they ate blubber as part of their main diet, they never got decay. It was the very simple introduction of sugar and you can see the dates where over the land trading started taking place that decay started going up. That’s actually a pretty convincing concept that out of touch doesn’t get that refined sugar. Even people that work on the sugar field had slightly elevated decay rate. There were 2 studies

(one in Tanzania and one in Kenya) of the people on the farms and their decay is slightly more elevated than the normal patient population. But not a whole lot.

Slide 48: Caries Rates (Refinement of carbohydrate results in…) It’s only when you get to the refined sugar area…it’s the baker who works there and even the dust in the bakery results in high concentrations of sugar being breathed in and feeding things. We see less refined sugars causing less decay than more-refined sugars. The brown flour or less refined flour are less cariogenic than the more-refined

Slide 49: In Vivo-Human StudiesThere’s a bunch of studies…and I’ve already given you the one that really kills me is the one about sugar consumption…the more sugar we consume, the less caries we get. It has nothing to do with the sugar. It’s just an artificial study and that’s part of what makes cariogenicity so hard to study. The best cariogenicity studies that I’ve seen….(doesn’t finish thought and moves on)

Slide 52 – In Vivo Human StudiesBrushing with fluoride toothpaste versus counseling for reducing sugar…almost 10x greater reduction in tooth decay. So if I’m going into a place to go do something, as much as I’d like to talk to the kids about healthier eating, the first thing I got to do is talk about healthier brushing. Almost 10x more effective at reducing decay than dietary counseling. And it comes back to my discussion with you that bacteria only need microgram of sugar, they don’t need pounds of it.

Slide 53 – Cariogenic Potential IndexWhere did we get these cariogenic potential indexes. There are a couple of studies that were run looking at rats and the rates of cariogenicity. If I feed a rat bologna, they don’t get decay. If I feed them raisins, they get decay. So all the mothers that say I’m not going to let my kids have nitrates, I’m going to take the bologna out and give them raisins…it’s just as cariogenic as giving them a Milky Way bar. It’s sticky, high concentrations of sugar and causes tooth decay

Slide 54 – Graph done by BowenThis is from Bill Bowen who is a cariologist. We can see that raisins, banana, and French fries are high on the caries index than corn chips or yogurt out at the other end. This was all done on animals. This is one of the few studies that have been done. As we talk about diet counseling, you have to think about dried fruits being horrendous. The healthy dried fruit cuts are very bad from an occlusal caries standpoint.

Slide 55 – What influences cariogenicityRetention of food makes a real big difference and then it’s acidogenic…its likelihood of causing that bacterial generated acid that makes a real big difference

Slide 56 – Clearance of Sugar from the MouthBanana is cleared slower. Bread cleared the slowest.

Slide 58 – History of Sugar Substitutes Sweeteners Artificial sugars have been around for awhile. They’re somewhat interesting. The pink packet…the saccharin…the USDA made it illegal in 1907 because it was less expensive than sugar. The sugar industry protested. This is actually a quote because it came from coal tar…it’s devoid of food value and extremely injurious to health…so they actually banned it in 1907. It was banned in Canada in 1977 because it caused bladder cancer. Anybody familiar with this one. It’s actually an interesting ban. When they got all done looking at it, the rat would have to consume 100 times their body weight per day in soda to get the concentration that was being shoved inside them to go prove it…that’s why it was never banned in the US.

Slide 59 – History of Sugar Substitutes Sweeteners (Cyclomate)Cyclomate, another accidental discovery, was marketed in the US as Sucaryl. Equivalent of 350 cans of diet soda per day resulted in bladder cancer.

Slide 60 – Sugar SubtitutesIt’s not metabolized, sweeter than sugar…so actually most of what’s in the packet is filler particle not actually the saccharin. Aspartame…Nutra-sweet…is the one that’s not usable in baked goods. It breaks down in baking. So you’re better off using the Truvia, Splenda and Sucaryl rather than aspartame because it can’t handle the heat. Splenda works well in heat. They make it so it has to be a teaspoon because somehow you always need to put a teaspoon of sugar in. Anybody use any of these sweeteners in Europe…how do they deliver them in Europe…a little pellet comes out of the dispenser, they get rid of all the other stuff

Slide 61 – Sugar Sustitutes (Sugar Alcohols)These are alcohol containing sugars. It’s interesting because sorbitol is probably the most popular of the bunch. Xylitol is the most expensive of the bunch. The reason why xylitol hasn’t come out as a highly popular item throughout cooking and sweetening is its cost to manufacture.

Slide 62 - Sugar Substitutes (Stevia)Stevia is the new one on the market. It’s become quite popular now. Still has not really captured any of the big markets compared to Splenda and Equal.

Slide 64- Caries InhibitorsXylitol – multiple studies but it requires it to be up in high concentrations before we see any of the actual reduction. Massive studies up in Alaska using xylitol gummi bears demonstrated without correcting hygiene practices could get some reduction in caries but you had to get above 6 grams of the product each day to make it effective. There are chewing gums with them and it is highly effective. We talked about it briefly…it is an alcohol sugar (a wood sugar) and it is effective at reducing. Let me skip out of this and go to a little bit of getting old.