What You Should Know About the Dental Implant Industry
Advances in dentistry within the last decade or so have led to incredible technological developments. Dental implants have become the treatment of choice to replace lost or missing teeth, and when done under proper surgical technique, success rates have surpassed 95%. When the concept of osseointegration or fusing titanium with bone was introduced to the dental community in the early 60s by an orthopedic surgeon known as P.I. Branemark, the application of this concept was adapted to dental use; implementing the procedure, however, into a dental setting was seen as risky and unpredictable. Success rates at this point in time rarely approached 55-60%, and many clinicians felt that their introduction into a patient’s treatment plan may be too premature for predictable success of a particular prosthesis. To improve success rates, alterations in the design of the dental implant surface were introduced most without sound, clinical evidence to back-up manufacturer’s claims of improved success rates. Through years of empirical experimentation, a titanium dental implant was developed that looked much like that of a natural tooth root. цена на фиксирана протеза
Some 40 years later, technology within the dental implant field has facilitated their colloquial use among general dentists and specialists. When the market for implant dentistry exploded not more than a decade ago, many implant manufacturers decided to alter the topographical surface of the implant fixture with unsubstantiated claims of improved success rates to win market share over the major implant companies that currently hold 85-95% of US dental implant sales.
Unfortunately, there is an enormous amount of poorly written research that is being introduced into the dental literature with false claims of improved success rates. In many instances, implant manufacturers have made changes to the design of their implant because of improved success rates seen with a competitor implant that has the proper research and clinical documentation. With the dental implant industry growing each year, this problem will never cease to exist.
As a potential implant candidate, there are several things you should know about this industry prior to continuing with treatment:
FACT: Doctors do not need formal surgical training on humans to place dental implants.
In fact, one implant manufacturer in particular holds educational seminars for doctors wanting to place dental implants over the course of a single weekend. That’s right, in just 2 days, doctors are given a surgical training certificate which states that they have formal training in surgical implant dentistry and therefore may place dental implants in a human subject. Unfortunately, the course does not train these doctors on human subjects, rather, on plastic jawbones.
FACT: The US government does not require FDA approval for a dental implant fixture to be marketed to the professional community.
The US government has a governing body that oversees biomedical devices and their potential implementation into the medical and dental community. If, for example, a dental implant meets certain criteria necessary for surgical placement into the human body based on prior submissions by other manufacturers which have tested the device, then the governing body will grant 510K clearance to the implant manufacturer. 510K clearance allows dental implant manufacturers (and other biomedical device manufacturers) to market their device without the need for prior animal or human testing! If another biomedical device has been previously introduced with similar intent, then the literature for the initial product can be used to formalize 510K clearance.