Friday, March 5, 2010

My discussion with Dr. Mike Miller.

I was having problem with my Optibond. I have always heard it was the best bonding agent, so I bought it and jumped in with both feet.
I was using it for about 2 years. One day I started to get people coming back with fillings, which I did with Optibond, coming out. Now all of these fillings were class Vs fillings. I am not talking about them coming out in 5 years. No, I am talking about them coming out in 3 months. I stopped using Optibond all together, and I was a bit pissed.
I have been meaning to ask REALITY about this. I finally did and this was the dialogue I had with the President of REALITY Dr. Mike Miller (Don't think I am all that. I wrote and he answered. I knew it was him by the end of our conversation because I remembered his writing style. This isn't my first time posting. They used to sign the posts and that is how I knew it was him). It is a bit long but I (and I think you will) learned a lot from this dialogue. Sorry about the spacing. In my cutting and pasting this is what it did and it wouldn't let me delete spaces.

I hate optibond
Okay I know you guys are smart. And I trust you almost exclusively.
I have been using SE Bond for about 8 years now. But the bond to etch has always been a big question mark to me.
So I looked up the best 4th generation bond and almost always Optibond was the #1 choice.
I bought it.
It was an exciting day. The old dog has learned a new trick.
And it stayed exciting for a long time until the first facial filling came out.
I kept my enthusiasm and redid the facial filling with Optibond AGAIN.
Then my excitement started to really go away when the one filling that fell out turned into a bunch more.
Then more and more and then more. Now I am redoing the fillings that fell out and I redid them with Optibond again.
What is going on?

I called the company they were obviously very surprised.
So the rep and I went over my technique, and it was exactly like the directions.

What gives?
Am I the only one or have you heard of this before.

I appreciate your honestly,
Just let me down easy.

I hate optibond

You are correct -- OptiBond FL has been our top-rated bonding agent for many years based on exemplary and extensive testing and clinical results. Before we can comment on why you had these failures, we need additional information. When you state that you “called the company” and the “rep” went over your technique, who was the “rep”? Was this “rep” located at Kerr’s California headquarters?

This is important because Kerr and most other companies have a policy of issuing a call tag for material that may be below their standards. If you talked to a Kerr “rep” and this procedure was not followed, then the “rep” was not doing his/her job. Did the “rep” even ask about the lot # or the expiration date? For our investigation, please give us the lot # and expiration date of the material you used.

Even though OptiBond FL is not very technique-sensitive, we still feel that our step-by-step instructions will help you achieve success. From your account, it appears that you followed Kerr’s directions, not ours. How did your application differ from that which we recommend? Did you shake the bottles before use? Or, if you used the unidose version, did you stir the material before application? How long did you cure it? What light did you use? What composite did you use? These steps/issues may seem trivial, but they can mean the difference between success and failure.

We have requested fresh material from Kerr for retesting purposes. The results will be posted shortly. In the meantime, please answer our questions so we can provide comprehensive solutions to your problems.

I hate optibond
Okay, I will answer all your questions.
Even though I not only think they are trivial I think they are kind of ridiculous.
I mean when some company puts out a product why are there all these stipulations on a product.
Like, "It is only good if you do all these things."
I am not trying to be difficult, but remember that I have used one product for a long time and it was good.
Then I changed to a new product and it is a lot of, "don't forget to store it at this temperature, or make sure you use this composite with it, oh and don't forget to shake it and make sure you are using a certain light and oh don't use the single dose you have to use this one and if you do all this then yes it is the best."
And also, "I hope you didn't get a bad batch."

Okay now that I got all that out of the way.

Now as far as the lot #. When I bought the product I put some in every room. So there is no way of knowing what room the patient came from. So to me, they are all bad. I have been using two sets. Do you want both of them.

I did call a rep and they did want me to send my product back for a new product.
She did not, however, ask me for a lot #. I do not remember if she asked me for the expiration date.
She seemed to be very knowledgeable.
But I didn't want to send it back because why would I want more of the product that doesn't work in my hands. I don't care if it is a brand new bottle or an old one. If my fillings are going to fall out I don't want a new batch. So I didn't send anything back.
I don't think we shake the bottle. And in talking to Kerr's rep she never mentioned this.
As far as the material, I was using the three step Optibond FL.
I have the DEMI light, and we cure for about 10 seconds and for deeper ones we do 20.
My composite of choice is Filtek Supreme.
I try to use all the finest products, and I pride myself on excellent work and when people are coming back with my fillings falling out, it is not only embarrassing but it is unacceptable.

I appreciate you helping me. I am sorry if I sound pompous, I don't mean to.
It is just this is my livelihood, and when doubt seeps into you patients they will just go on down the road.

While it is understandable that you are frustrated – we all need to face the music when something or somethings go wrong during patient treatment – the questions are pertinent and relevant, not trivial or ridiculous as you proclaimed them to be. All you have to do is spend a morning at a lab bench to realize how important it is to do procedures such as shaking the bottle or blotting rather than drying with air.

As mentioned previously, while OptiBond FL is not particularly technique-sensitive, it is not immune to application changes. As a matter of fact, NO bonding agent is immune. In your original post, you mentioned you have been using “SE Bond”, which we assume is Clearfil SE Bond, another really terrific bonding agent and one which is also not particularly technique-sensitive. On the other hand, if you aggressively thin out the bond resin with this product, its performance will suffer. Temperature storage is also a MAJOR factor with some products as is adequately curing it. We have always stated that details matter. Ignore them and you risk failure.

However, this doesn’t mean you necessarily did anything wrong. In asking you for info such as lot #s, manufacturers can check them against samples they retain to see if something has slipped past their quality control (QC) folks. It would be nice if every batch of every product was perfect, but whether it is a dental bonding agent or a car (Toyota), we live in an imperfect world and stuff happens.

Same thing applies when we test a product. If our results don’t jive with those claimed by the manufacturer, the first thing we do is ask for additional samples from another batch, which connotes a different lot #. This is not arcane science – it is the usual and customary way of trying to solve a problem.

We are on your side and feel your pain. That’s why our mission statement is “Protecting patients by informing dentists.” No dentist wants to redo his/her works of art, especially if the failure were caused by something out of his/her control such as a bad batch of bonding agent, which is not readily apparent during the application procedure.

But until due diligence is done, it is important not to jump to conclusions. It is important to know the lot # or #s of the batch(es) you were using. Ultimately, if a bad batch is discovered, a recall may be necessary. Alternatively, you can send the questionable OptiBond FL to us and we can perform the tests alongside the material being provided by Kerr.

Re:I hate optibond
First and foremost I want to say thank you for your time and talking to me.
Second I would like to say I am sorry for the title of this thread. It should be "I am frustrated with Optibond"

Okay in response to your last response,
You said, "All you have to do is spend a morning at a lab bench...." I would love to do that, and if you are inviting me to come to Kerr research center I am 100% game. I have always been intrigued by the process.

I get the whole quality control thing and the imperfect world thing, but what I don't get is if you have to shake a bottle for maximum effectiveness why doesn't it say, "SHAKE BEFORE USING" on the bottle.
Or if you have to store it at a certain temp other than room temp then it should indicate.
Now we are not talking about the filling failing in 10 years instead of 12 years. We are talking about complete failure of a product in less than 4 months. So if shaking is necessary....say it.

Like you said most products have an application change well then it should be in bold letter somewhere.
Like why do I have to talk to you guys about an application change in a product. Why am I not reading it somewhere?
Why do I have to have tons of failures before I find out I am suppose to do something different and simple like shake the bottle.

Lot numbers....

And I am happy to do due diligence, and I would be happy to go over my technique with you as well.
I want to use a 4th generation bonding agent, and I want to use the best one.

I hate optibond
Actually, the note about sitting down at the lab bench was from us at REALITY, not Kerr. We have seriously considered holding small study-club-like group sessions in our research lab for those who are interested in really learning about all the details we publish. Not just bond strength of adhesives, but seeing for yourself what happens, for example, when you don't cure a composite long enough. Based on your comments, we'll put the plan into action sooner than later. Look for something in our e-newsletter shortly.

As far as the shaking the bottle issue, we cover this subject explicitly in the bonding agent introduction in The Ratings. This is what the section states: "Many bonding agents suffer from phase separations of their components in bottles and unidose vessels. This means that most bottles should be shaken before dispensing and the contents of unidose vessels should be stirred before applying to the preparation. Some bottles even have a small ball inside to act as a shaker to help mix the components. When in doubt, shake or stir." You are correct that manufacturers should also have this type of instruction in their directions for use, but the reason you are a REALITY member is hopefully to read our stuff and overcome the errors of omission and commission by manufacturers.

We have tried for almost 24 years to get manufacturers to write better directions, but we are fighting a losing battle. It is industry-wide and not likely to change any time soon.

We will forward to Kerr the lot #s you provided, and we will report on the outcome of our new tests shortly.

Re:I hate optibond
About the study-club-like research lab CE....sign me up. I would love to be part of the first class (this would be the maiden voyage. Totally free. Yeah everyone would be picked up in the REALITY private jet and treated to a weekend to the nines. Champagne and caviar, yeah I will be a part of that.)
In you last post you talk about generalities when it comes to bonding agents. Let's talk about Optibond specifically. It is in three individual bottles, does it need to be shaken.
Are there any other specific instructions that pertain to Optibond.
I got to tell you this is frustrating stuff and can't imagine how frustrated you guys must be.

Re:I hate optibond
We are very proud that our REALITY members have a terrific imagination, especially when it comes to "free" stuff! It's kinda like treating a relative for free -- you get what you pay for!

OptiBond FL actually comes in TWO bottles or unidose, not three. If you have three, that could be the problem! And yes, the bottles need to be shaken and the unidose need to be stirred.

I hate optibond
Okay okay so my Optibond only has two bottles. I got confused because I had nine bottles on my desk trying to give you all the lot #'s.
I am going to give it another try...this time shaking it.
I will let you know.

And I would still come to the CE class even if there was no REALITY jet involved.

I hate optibond
Don't use it until we can retest it. There may be something else wrong with it other than your not shaking the bottle. That's just one piece of the puzzle. We should receive our shipment of fresh OptiBond today as promised by Kerr. Let us check it out before you try it again.

I hate optibond
I want to say that Optibond has been the #1 4th generation bonding agent for as long as I can remember.
Why are you making me wait?
Do you think you are going to get a new batch of this product and something drastically going to change? Have they changed the product?
And you mentioned that shaking is not the only piece to this puzzle. Well what are the other pieces (that you know that Kerr won't tell me)?

Now I am starting to think that the REALITY CE bench top course should be sponsored by Kerr.
Yeah and we can fly on the Kerr jet (I bet it is a lot nicer than the REALITY jet).

If this is Dr. Miller, I know you are a big runner. I am leaving for Albany GA tomorrow for the Snickers Marathon on Saturday. It is suppose to be a fast and scenic marathon. Lows in high 40's and high in the lower 60's

I hate optibond
The reason we want to test OptiBond FL again is to be sure nothing has changed other than the addition of ytterbium to make it more radiopaque. We were just told about this tweak by Kerr since this thread started. The addition of ytterbium should not change the performance of the product, but that is an unknown until it is tested. Even if ytterbium were not added, we would still test the product due to your untoward experience. This is what we do when we find out something may be happening with a product. As we stated previously, this may be a QC issue.

The other pieces of the puzzle relate to items such as whether the raw materials purchased by Kerr to manufacture the product may have been changed by their suppliers. You just never know. This kind of stuff happens frequently, but usually it does not affect a product's performance.

Good luck in the marathon. Your performance could depend on your level of hydration, carb loading, wind resistance, etc. More pieces to the puzzle......

I am telling you the guys at REALITY are unbelievable. I give them my fullest recommendation. They are advocates for the general dentists. Kind of like the AGD (shameless plug). I hope you learned a lot and are kind of outraged at the way companies get away with stuff. I sure am.

Have a great weekend, john

PS. I am going to tell you something that I am very embarrassed about.
When I was checking the Lot #'s on the bottles I found something else on the bottles.
The expiration date. Two of the 6 bottles were over the expiration date. I then went and chastised my assistants. We then went through all our stuff to make sure it is all fresh.
It all was.
It is all about checks and balances and apparently our checks and balances didn't cut the mustard.


Anonymous said...

I was like you and saw the higher numbers and was going to try it out. However it was more expensive than the Prime and Bond NT I use. But I did get some and actually have a bottle brand new and the optibond solo brand new sitting there collecting dust. The reason is I did try it somewhere else and I did not like it because I noticed the film thickness was more than P&B. I could actually see the bonding agent in between the composite and enamel. So I never used it again. I was going to sell it to someone or donate it to a clinic but have not gotten around to it. For class V I have gone back to using a fuji IX glass Ionomer in the root areas and posterior teeth.

Carson Calderwood said...

Thanks for posting this, keep up the blog.
Dr Calderwood


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