FDA Issues Final Regulation on Dental Amalgam

FDA NEWS RELEASE
For Immediate Release: July 28, 2009
Media Inquiries: Peper Long, 301-796-4671, mary.long@fda.hhs.govConsumer Inquiries: 888-INFO-FDA

FDA Issues Final Regulation on Dental Amalgam

The U.S. Food and Drug Administration today issued a final regulation classifying dental amalgam and its component parts – elemental mercury and a powder alloy—used in dental fillings. While elemental mercury has been associated with adverse health effects at high exposures, the levels released by dental amalgam fillings are not high enough to cause harm in patients.
The regulation classifies dental amalgam into Class II (moderate risk). By classifying a device into Class II, the FDA can impose special controls (in addition to general controls such as good manufacturing practices that apply to all medical devices regardless of risk) to provide reasonable assurance of the safety and effectiveness of the device.
The special controls that the FDA is imposing on dental amalgam are contained in a guidance document that contains, among other things, recommendations on performance testing, device composition, and labeling statements.
Specifically, the FDA recommended that the product labeling include:
A warning against the use of dental amalgam in patients with mercury allergy;
A warning that dental professionals use adequate ventilation when handling dental amalgam;
A statement discussing the scientific evidence on the benefits and risk of dental amalgam, including the risks of inhaled mercury vapor. The statement will help dentists and patients make informed decisions about the use of dental amalgam.
Dental amalgam is a “pre-amendment device,” which means that it was in use prior to May 28, 1976, when the FDA was given broad authority to regulate medical devices. That law required the FDA to issue regulations classifying pre-amendment devices according to their risk into class I, II, or III. Although the FDA previously had classified the two separate parts of amalgam – elemental mercury and the metal powder alloy – it had not issued a separate regulation classifying the combination of the two, dental amalgam. During this time, however, dental amalgam has been subject to all applicable provisions of the law.
Today’s regulation also reclassifies the mercury component of dental amalgam from Class I (low risk) to Class II (moderate risk).
Over the past six years, the FDA has taken several steps to assure that the classification of dental amalgam is supported by strong science.
In 2002, the agency issued a proposed rule to classify dental amalgam and identify any special controls necessary for its safe and effective use.
Due to a high number of comments on that rule, the agency held an advisory committee meeting in 2006, inviting dental and neurology experts to review existing scientific data on dental amalgam, especially with regard to its toxicity in pregnant women and children.
The agency drafted a review of recent and relevant peer-reviewed scientific literature on exposure to dental amalgam mercury. The advisory committee asked that the agency conduct an even deeper review of the scientific literature on this topic. In all, the agency considered some 200 scientific studies.On April 28, 2008, the FDA reopened the comment period on the 2002 proposed classification in order to elicit the most up-to-date comments and information related to classification of dental amalgam. Today’s rule reflects the years of agency review on this topic.
FDA’s Web site on dental amalgam:http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DentalProducts/DentalAmalgam/default.htm

Dental Care On a Budget- How to Make Dentistry Affordable

Health care costs are on the rise. Today more than ever people are looking for more affordable options. There are three factors that a consumer needs to consider when making a decision: Quality, Service, and Cost. The best quality, best service, and lowest price cannot co-exist. So how can you get the best quality dental care, the best service, and still be able to fit it in your budget?

There are several ways you. Let me help you sort this out. My first advice is not to choose your dentist based on cost. There are many factors that come into play when a dentist determines how much to charge for their services. While there's no guarantee that you get the best quality and service when choosing the most expensive dentist, you can rest assured that the best dentistry is not the cheapest. Choose a dentist that is highly recommended. Find out what the existing patients have to say. It's important that you feel welcomed and comfortable in your dental home. Make sure the doctor and staff are professional, courteous, and answer all your questions. You should not feel rushed.

Once you found your new dental home let your dentist know what your budget is for your dental care when discussing the necessary treatment. This will help your dentist plan your treatment in stages over a period of time that is comfortable for you financially. You and your dentist must have a goal in mind before starting treatment. Your dentist should be able to develop a lifelong plan for your dental health.

There maybe several different options for treatment. You and your dentist can choose the best option based on your needs, desires, schedule, and budget. Sometimes, the best that dentistry has to offer is not within the budget at the present time. That doesn't mean that it can't be an option at a later time. There maybe alternatives for treatment in the meantime.

Lastly, payment plans can be arranged usually through a third party such as CareCredit (www.carecredit.com) as well asothers. Only certain dental office offer CareCredit. For many patients it's a great way to get the treatment needed right away and pay for it over time. There are interest free options for upto 24 months.

Don't hesitate to give us a call at (559) 229-2288 or visit our website at www.tmdds.com for more info.

The cost of dental implants

Dental implants are becoming more and more popular as the number one choice to replace missing teeth. The benefits of dental implants are enormous. A dental implant is the closest thing we can offer to a natural tooth. The are very versatile. We can replace a single tooth or all your teeth with dental implants. Implants can be used to stabilize dentures or partials making denture adhesives and embarrassing denture moments a thing of the past.

The most common question is regarding cost of dental implants. The cost of implant treatment depends on the complexity of the surgery, the number of implants needed, and the final prosthesis whether it be an implant supported removable denture or implant supported crowns and bridges that are not removable and you brush them right in your own mouth.

One factor influencing the cost of implant treatment is the complexity of the surgical procedure. As the complexity fo the surgery increases so does the skill and training required to place dental implants in the mouth safely and restore them with a correctly designed prosthesis. There are different teaching institutes out there and varying degrees of training. One of the best institutes for training on the surgical placement of dental implants is the Misch International Implant Institute (http://www.misch.com/institute.html). The program is taught by Dr. Carl Misch. One of the best centers teaching the restoration of dental implants is the Kois Center (http://koiscenter.com/default.aspx). That program is taught by Dr. John Kois. The training in these institutes is extensive and produces some of the best implant surgeons and restorative dentists in the world. I'm not just saying that because I trained there :) Visit these websites and you'll see for yourself. Do some research and see how many articles Kois and Misch have published.

The number and size of the implants required depends on many factors including the design of the prosthesis, functional demands, and esthetic demands. Part of planning for implant treatment is much like what an engineer or an architect would do when planning a project. These implants wil be placed to replace teeth to chew and to look great. There are too many individual variations for one plan to fit everyone's needs. If you are considering dental implants we encourage you to visit our website at http://www.tmdds.com/ and call us at (559) 229-2288 to schedule a consultation at no charge. Check out our past blogs. There is some more helpful information on dental implants.

In summary, the only way to know how much implant treatment would cost is to have a thorough evaluation by a well trained dentist.

Gum disease and risk for pancreatic cancer

Pancreatic cancer is the fourth leading cause of cancer death in the United States. Recent studies shows that men who have periodontal disease have a a 64% greater chance of having pancreatic cancer than men with good oral helath. This is a significant finding especially that these men are men that never smoked.

"Our study provides the first strong evidence that periodontal disease may increase the risk of pancreatic cancer. This finding is of significance as it may provide some new insights into the mechanism of this highly fatal disease," said Dr. Michaud, in the Jan. 17 issue of the Journal of the National Cancer Institute.

It is believed that the systemic inflammation and elevated C-reactive proteins found in patients with periodontal disease may play a role in the cause for pancreatic cancer. Dr. Michaud and colleagues noted that among the men in the study with periodontal disease, levels of C-reactive protein were 30% higher compared with men with no periodontal disease, lending credence to the idea that inflammation could play a role in carcinogenesis. The crude incidence rate for pancreatic cancer among all men with periodontal disease was 61/100,000 person-years, compared with 25/100,000 for all men in the cohort without periodontal disease. Among never-smokers with gum disease and tooth loss, the crude incidence rate was: 61/100,000 person-years, compared with 19/100,000 among all never-smokers with healthy gums.

"Alternatively, periodontal disease could influence pancreatic carcinogenesis through increased generation of carcinogens, namely nitrosamines," they wrote. "Individuals with periodontal disease and poor oral hygiene have elevated levels of oral bacteria and have much higher nitrosamine levels in their oral cavity due to nitrate-reducing bacteria. Nitrosamines and gastric acidity have been hypothesized to have an important role in pancreatic cancer; numerous studies support this hypothesis."

Lifelong Plan for Dental Health

I would like to share with you my approach to your dental care. My ultimate goal for you in my practice is to achieve the highest level of dental health possible for you and maintain it for a lifetime. Each individual is either susceptible or resistant to three dental diseases that can lead to tooth loss: Decay, Gum Disease, and Tooth Wear. We start by identifying what you are at risk for. This Risk Assessment will determine the best course for treatment.
A lifelong plan for your dental health involves a detailed exam and a customized treatment approach. In addition to the comprehensive exam which we do for each patient I may need a series of photos and casts of your teeth to evaluate the way your chewing system functions. A lifelong plan for dental health will address bite problems that are accelerating the way your teeth are wearing out and breaking down. It will address tooth decay and try to reduce your risk for future decay. It will address gum disease that is causing you to lose bone from around the roots of your teeth and attempt to slow it down enough so that your teeth outlast you. It will address cosmetics so that your smile is at its best.
We strive to make your dental care fit your life. Basic dental care is a good place to start if there are budget or schedule limitations at the present time. We are happy to treat any of your immediate concerns and help you maintain your dental health. The great thing is you can always let us know when you are ready for a life long plan for your dental health or cosmetic dentistry at any time.

Not just baby teeth

Baby teeth are often looked at as temporary teeth. Adult teeth are even called permanent teeth. Baby teeth just don't seem as important. The fact is baby teeth serve a very important purpose.

Baby teeth are important in a child's development. They maintain space and help guide the permanent teeth into position. Early loss of baby teeth will cause problems in the proper development of the permanent dentition. This may lead to problems in the development of the upper and lower jaws and facial muscles. Some of these problems maybe very difficult to correct later on. Prevention is the best option.

Baby teeth are essential in making sure a child can eat a healthy diet. They're also important in speech development. Healthy nice looking teeth are also important in building self confidence and self esteem. Children do have pain related to cavities which can affect their performance in school. This is why schools now require that a child have their teeth examined by a dentist before enrolling.

Baby teeth last 5-10 years or longer depending on the tooth. It's crucial that every effort is made to ensure they stay healthy and that a child is accustomed to early dental care. These habits of proper oral hygiene and going to the dentist will help them throughout their life in maintaining their dental and overall health.

A child's first dental visit should occur before their first birthday. It may not be possible to get X-rays or do a very thorough exam at that point. This should be a fun visit to make sure the child is accustomed to going to the dentist and to see it as a positive experience. We do not believe in forcing a child to do anything or restraining them. If there's urgent need for care there are specialist who can treat kids while sedated. If you have any questions please visit our website at http://www.tmdds.com/ or call us at 559-229-2288. We're here to help.

Tooth Wear

Tooth wear also known as attrition is the breakdown or wearing out of the chewing surfaces and edges of the teeth. We previously discussed erosion which is the loss of tooth structure by chemical means, usually acid from diet or the stomach. Attrition is a different in that it's caused by friction. This type of wear can only occur when the top and bottom teeth rub together. The intensity of the force that the teeth rub against each other, the frequency, and the presence of some modifying factors will have a huge effect on the extent of the damage.

Some factors that can contribute to tooth wear include tooth position, lack of slaiva (xerostomia), acid, and certain habits like teeth grinding (bruxism). Lets examine each of these a little closer. The way teeth are positioned can sometimes cause the teeth to wear out faster than your age indicates. The mouth is a chewing machine. Think of teeth like gears that fit together. If the fit is not ideal you should expect more wear and tear on the system. Lack of saliva can lead to more wear because saliva acts as a lubricant and buffers acids. Acids often teeth making the effect of friction from chewing or habits like teeth grinding more damaging. Teeth grinding is not something the system is designed to do. It serves no purpose, but some of us, like myself are hard wired in our brain to do this. There's nothing we can do to treat it at this time. We can only protect the teeth by the use of a guard.

The reason it's important to address teeth wear is because it's irreversible. Once that tooth structure is lost it's gone forever. If recognized early enough we can minimize future damage. At some point the teeth will have to be restored because of a functional reason or a cosmetic reason.

Treatment options must be based on the diagnosis of what's causing the problem. For more info please visit our website at http://www.tmdds.com/ or call us at 559-229-2288.