The U.S. Food and Drug Administration (FDA) granted the first-ever clearance 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). The significance of this clearance is that regeneration of periodontal tissues, destroyed by gum disease, can be returned to a natural state of health. Imagine the health of the tooth structure as a teenager again, while preserving the patient’s smile line. Imagine treating your periodontal patients with the anticipation of regeneration! Imagine no more…
True Regeneration: Why this clearance matters
This is the first FDA regulatory clearance of functional tissue regeneration with a specific protocol and device in any medical specialty, not just in dentistry. We have at our fingertips the ability to restore function to patients impacted by periodontal disease in a minimally invasive way. The difference between tissue healing by repair and regeneration is profound. Regeneration is return to normal architecture and functional health; repair is not. Repair is scar tissue. True Regeneration™ can be obtained with the LANAP protocol and the PerioLase MVP-7 dental laser in the presence of gum disease – one of the most stubborn, persistent, and widespread infectious diseases according to the Surgeon General and the Center for Disease Control 2010 NHANES report.
The LANAP (LAR) protocol is able to generate these results without the use of biologics, exogenous growth factors, bone grafts, artificial membranes, scaffolds, or stitches. The clearance gives “institutional” regulatory validation of scientific proof for a unique healing event, long thought of as unpredictable and too difficult to routinely accomplish.
Redefining the gold standard of care?
By using the body’s own natural healing response in a clean, closed environment, the expectation in periodontics is now the same as in endodontics – complete regeneration. What makes this remarkable is the predictability of tissue regeneration and bone growth despite the presence of oral contaminants we have in our mouths. Teeth that otherwise might be lost to gum disease can now be saved because the bone in the jaw that holds the teeth in place has been re-grown. The ability of the PerioLase MVP-7 to create a stable fibrin gel clot to “seal” the gingival collar makes possible the closed environment needed for this type of healing.
In addition, this clearance is redefining the metrics of “return to periodontal health” from that of a manual probing process, to the expectation of True Regeneration that results in increasing bone density over time. No longer does periodontal health merely mean the absence of signs and symptoms of destructive gum disease (i.e. gingival indices). FDA Institutional recognition now has significant implications for periodontal patient informed consent.
What is LAR?
LAR is laser-assisted regeneration. LANAP=LAR because the protocol is standardized and clinicians have obtained consistent, predictable, positive results since the first FDA clearance in 2004 for cementum-mediated new attachment. LAR is only possible with the 26 steps that comprise the LANAP protocol. These are the same steps as its predecessor “Laser ENAP”.
The two human histology studies undertaken by Millennium provided the FDA with the necessary scientific research to confirm new alveolar bone, new cementum, and new PDL leading to the clearance periodontal regeneration – True Regeneration. Currently, more than 30% of active American Academy of Periodontology ( AAP) members offer the LANAP protocol to their patients due to both the predictability of results, the pinnacle of periodontal healing, and the high patient acceptance. The LANAP protocol was developed by general dentists to help other general dentists provide a treatment option that patients would accept, and adopted by general dentists and specialists alike.
LAR is different than GTR
Growth factors may have site-specific responses, vastly different from a full mouth response or disease limited to posterior teeth. To successfully perform 4 separate areas of molar regeneration, a full GTR treatment program including exogenous growth factors and bone grafting would be required. The difference is the level of patient comfort and variation in technique. The LANAP protocol is not as technique sensitive as GTR, no exogenous growth factors, bone grafts, artificial membranes or sutures; and all clinicians are properly trained to obtain positive results. LANAP technique relies on the truth of laser physics and specific tissue interactions incorporated in the parameters of the PerioLase MVP-7 developed specifically for the treatment of gum disease with the LANAP protocol. The skills of the individual general dentist or specialist are not as critical. ‘Less’ effort and energy translates to ‘more’ in terms of the healing response, so the procedure tends to be easier to do for all clinicians.
LANAP=LAR is the new gold standard for treating and healing the periodontal patient of all case types. Patients now have the comfort of knowing the LANAP protocol offers hope for hopeless teeth, restoring function, re-growing bone, and supporting tooth structure in a much less invasive manner. Patients who may have previously avoided traditional treatment due to fear can now be offered a gum disease treatment option that is evidence-based and FDA-cleared for True Regeneration. Given the oral-systemic health connection and implications for total body health, it is vital for patients to have an effective treatment option they accept.
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