First laser gum disease procedure to gain FDA clearance – “Laser assisted new attachment procedure or Laser-ANAP®”

CERRITOS, Calif., October 8, 2004 / PRNewswire / – Millennium Dental Technologies, Inc. (MDT) announced today it has received the first FDA clearance ever for a laser-based periodontal (gum) disease treatment protocol while using the first ever digital dental laser–the PerioLase® MVP-7™.

50 people out of 100 have moderate to severe gum disease, 40 out of the 50 don’t know it, and only 3 people out of 100 will ever get treated before it’s too late.

Gum disease is a silent, painless, chronic, communicable, bacterial infection that often goes undetected or ignored until severe gum and bone destruction catch the individual’s attention. Traditional treatments for gum disease have, until Laser-ANAP, been perceived as painful with a long and uncomfortable recovery, scaring patients away and causing the epidemic numbers suffering with this preventable and now attractively treatable disease.

The US Food and Drug Administration cleared Laser-ANAP® (“Laser Assisted New Attachment Procedure”) with a unique and specific claim for,“cementum-mediated new periodontal ligament attachment to the root surface in the absence of long junctional epithelium.”

FDA clearance for Laser-ANAP® using the PerioLase® MVP-7™ variable pulsed Nd:YAG dental laser follows three years of research at Louisiana State University, School of Dentistry, New Orleans, by principal investigator, Professor Raymond A. Yukna, DMD, MS, and coordinator of post-graduate periodontics at LSU. Professor Yukna led a controlled, blinded, clinical and human histology study that evidenced new root surface coating (cementum) and new connective tissue (periodontal ligament) formation (collagen) on on tooth roots by stimulating existing stem cells to grow following the use of thePerioLase® MVP-7™ & Laser-ANAP® protocol.

“These results are very positive, very consistent, and very encouraging related to the treatment of deep gum pockets,” said Yukna. “Dentists have been looking for ways to regenerate some of the tissues lost to gum infections and Laser-ANAP® is an exciting and revolutionary treatment protocol showing microscopically that we can form a new root coating (cementum) and new connective tissue attachment (collagen). Our consistent results (all LANAP treated teeth showed a positive result) suggest that the best possible type of healing can be obtained using the specific Laser-ANAP® protocol. This presents a wonderful alternative to traditional surgery.”

The preliminary phase of Yukna’s study was published in the International Association of Dental Research, January, 2004. On March 12, 2004, Dr. Yukna and co-workers presented their complete findings at the International Association of Dental Research Meeting in Hawaii in a paper titled, “Human Periodontal Regeneration Following the Laser Assisted New Attachment Procedure.”