This world’s first FDA clearance for tissue regeneration is groundbreaking in that Millennium Dental has demonstrated that tissues lost to disease can be fully regenerated, including return to functional health.
The pathway of tissue regeneration researched and cleared was tissues lost and destroyed as a result of infectious, inflammatory periodontal disease. This suggests there may be other pathways to tissue regeneration in the body that could now be investigated.
- First FDA clearance of functional tissue regeneration as a result of a protocol and device
- True Regeneration™ of periodontal tissue lost to gum disease – new alveolar bone, new cementum, new periodontal ligament
- 85 per cent of US adults have some level of gum disease (periodontal disease)
- 50 per cent of US adults have moderate to severe gum disease. Of this group, 40 per cent don’t know they have the disease, and only 3 per cent accept traditional treatment.
- True Regeneration™ only achievable with the LANAP® protocol
- LANAP protocol = LAR (laser-assisted regeneration)
“Our preliminary understanding is that we are able to stimulate and activate stem cells, fibroblasts in particular, to form the necessary cellular components that turn into regenerated tissues. This is the first example of functional regeneration as a result of a protocol and device, where regeneration would otherwise not occur,” states Robert H. Gregg II, DDS, co-founder of MDT, inventor of the LANAP® protocol, and co-developer of the PerioLase® MVP-7™. “If we can regenerate tissues destroyed by infection and inflammation in a cesspool of saliva and bacteria, the implications for what else could be regenerated elsewhere in the body are worth investigation.” The PerioLase® MVP-7™ received regulatory clearance using the LANAP®/LAR™ protocol for: “Periodontal regeneration – true regeneration of the attachment apparatus (new cementum, new periodontal ligament and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP®protocol.”(FDA 510(k)-151763)
True Regeneration returns function to diseased areas naturally
Repair, for example, is not regeneration. Regeneration is return to normal architecture and functional health; repair is not. True Regeneration™ can be obtained despite the presence of periodontal disease – one of the most stubborn, persistent and widespread infectious diseases according to the Surgeon General and the CDC 2010 NHANES report in the Journal of Dental Research on the prevalence of periodontal disease. (J Dent Res 89(11):1208-1213, 2010).
The LANAP/LAR procedures with the PerioLase MVP-7 achieve these results with:
- No biologics
- No growth factors
- No exogenous bone grafts
- No foreign membranes
- No scaffolding
- No stitches
MDT has trained 2,000 credentialed LANAP regenerative specialists that include general practitioners and periodontists alike. LANAP regenerative specialists are found in every US state and major metropolis, as well as Puerto Rico, the US Virgin Islands, and Guam.
Dawn M. Gregg, DDS, Director of Training for the Institute for Advanced Laser Dentistry, states, “This new FDA indication for use changes the meaning of ‘return to periodontal health’. No longer is return to periodontal health defined by filling holes or cutting away tissue. The FDA clearance reflects what we understood from two human histological studies – the LANAP protocol produces both periodontal tissue regeneration and function to previously diseased tissues.”
Andrew Sullivan, DDS, Chair of Periodontics at Rutgers, says,“As Chair of the Periodontics Department of Rutgers School of Dental Medicine, I was delighted to learn Millennium has received acknowledgment from the FDA that LANAP can achieve the “Gold Standard” in periodontal therapy – true periodontal regeneration. Rutgers periodontal residents are trained in the most advanced techniques, including the LANAP protocol.”