Implantium system TGA approved

Korean dental implant manufacturer, Dentium, has received approval from the Australian Therapeutic Goods Administration (TGA) for its range of Implantium dental implants and Osteon bone grafting materials in time for its launch at the 32nd Australian Dental Congress.

Dental implants are a popular treatment modality in Korea with an estimated 50-60% of the country's 21,000 dentists providing implant surgery. Dentium holds approximately 30% of the domestic Korean market with 50-60% annual growth since the company was established. Their manufacturing capacity is 1.9 million units per year. Korean-made implants account for some 60% of the market with the remainder shared amongst the traditional European and US manufacturers.

"Implantium implants are very well known to Korean dentists," said Mr Steven Kim, general manager of Implantium Australia, "and we hope they will equally now become as familiar a treatment option in Australia as other Korean products such as Hyundai cars and Samsung electronics have. As well as the range of implants, we are also introducing our bone grafting materials."

Dentium was founded in June 2000 to manufacture dental implants for the domestic market. According to Mr Kim, however, the long-term vision is to become a player in the global implant market supplying the highest quality products and customer service. The company has CE 0123 certification and FDA approval for the US market together with many patents in Korea.

The Implantium range

The Implantium range of implants, one of several lines Dentium manufactures, are mount-free with an internal conical seal connection and tapered fixture with three self-tapping blades.

The mount-free design makes for simple and easy implantation and saves chair time by omitting mount adaptation and removing the mount from fixture.

The optimal fixation screw (micro threaded platform) encourages initial stability and maximum sealage between the cortical bone and the fixture, offering proper stimulation to the marginal cortical bone adaption and minimising loss of cortical bone.

The three self-tapping design blades minimise bone destruction and their tapered apical shape promotes easier penetration. The rich bone housing design creates extra bone filling spaces and the sharper edge penetrates and engages to the bone readily.

The bacteria resistant highly polished surface of the tapered bevel platform design makes bone profiling unnecessary at the first or second surgery.

The tapered conical hex connection between implant and abutment interface ensures hermetic sealing. The biologic connection distributes the load to the fixture evenly which minimizes bone loss.

Dentium also has the Simpleline range for one stage surgery, the Temporary line (Ø2.0mm, Ø2.5mm) for provisional restorations and Slimline (Ø3.0mm, Ø3.5mm) for narrow ridge and narrow gap between teeth.

Implantium has three surfaces available: SLA, Active Surface and Nano-Active Surface; at present the SLA and Active surface will be available in Australia.

SLA (Sandblasting with Large grit and Acid etching) treated surfaces make implant surfaces rougher, thus increasing surface area. It also promotes adherence of the bone cells and improves initial stability through mechanical engagement.

Acid etching removes the oxidation layer of the surface and increases roughness of the surface. It promotes the thickness of the oxidation layer evenly and forms the fine titanium surface in nanometer size which has excellent bio-compatibility.

The combination of a micro thread, SLA surface treatment, load distribution and sealing effects of the internal cone-type connection makes Implantium successful in long term survival with less bone loss around fixtures.

The Active surface is a micro-porous Ti oxide layer which is a Ca and P combined surface. The morphology and chemical components of the Active surface deliver a better environment for the osteoblast growth and new bone formation.

A retrospective study

A retrospective Study of Implantium implants: Clinical and radiographic results of 22 months by Jung-Won Hwang, DDS, MSD, PhD and Young-Kyun Kim DDS, MSD, PhD.

With 252 Korean-made implants which were implanted in 119 patients as subjects, the author observed clinical results for 22 months, evaluated the survival rate of the implants, and also examined the degree of marginal bone loss for the implants during the first year, drawing the following conclusions.

Regardless of various implantation locations, kinds of prosthesis, the length and diameter of an implant, the osseointegration success rate of Implantium implants and clinical accumulated survival rate for the period of implant being used (an average 5.7months) was 100%.

Marginal bone loss immediately after implantation was 0.16mm and marginal bone loss around the implant after a year of use was 0.54 (SD 0.64). Average marginal bone loss for the first year was 0.44mm (SD 0.55).

The short-term survival rate of Implantium implants showed excellent results, but continuous additional study is required to increase the objectivity of clinical and radiological results.