Clinical study laser tech

CERRITOS, California--The University of Colorado, University of Maryland, and University of Louisville are the academic cornerstones of a multi-centered study to further document the clinical success of the LANAP protocol for the treatment of gum disease.

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While the procedure has already earned FDA clearance, this university-based research is expected to advance the technique's adoption by dental professionals and help increase periodontal treatment case acceptance.

Titled "A Multi-Center Single Blind Longitudinal Study of the Laser-Assisted New Attachment Procedure Compared to Scaling and Root Planing Alone, Modified Widman Flap Surgery, and Coronal Debridement Alone in the Treatment of Chronic Periodontitis," the research is being conducted at five investigational centers by three university-based and three private-practice principal investigators across the United States.

The study is a randomized, calibrated, prospective, double-blinded investigation using a four-quadrant, split-mouth design with modified Widman flap as the positive surgical control, coronal debridement as a negative control and scaling and root planing as the positive non-surgical control. That places the results at a high level of reliability.

Research is under way in Denver, Colo.; Fort Lauderdale, Fla.; Lafayette, La., and Baltimore, Md. The final center will launch soon at the University of Louisville. Patients will be treated during the next eight to 12 months and followed for a year after treatment.

The intensive study is expected to last two years with results available in 2013. The study was initiated by the Institute for Advanced Laser Dentistry--a nationally accredited organization dedicated to the research, practice, and teaching of advanced laser dentistry therapies--with financial and technical support from Millennium Dental Technologies.

Traditional treatment for periodontal disease involves flap surgery, resulting in only 3% of those diagnosed actually receiving treatment. The FDA-cleared LANAP protocol uses a laser to clear away infection without traditional cutting of the gums.

This results in clinically proven regenerative outcomes, offering patients less postoperative pain and fewer treatment sessions with quicker recovery times and lasting results. Study results are expected to underscore the clinical success of the protocol, which has successfully treated more than two million patients worldwide.

"I am particularly excited to be project director of this important multi-center clinical trial comparing [the LANAP Protocol] to other periodontal treatments," says Raymond Yukna, DMD, MS, a periodontist and leading researcher in bone-building techniques and technology. "Millennium Dental Technologies appears to be the only laser company willing to 'put its money where its mouth is' by sponsoring such a study. I anticipate that the research data will reinforce the results routinely obtained by current LANAP practitioners."

Dr. Henry Greenwell, director of graduate periodontics at the University of Louisville School of Dentistry, agrees.

"Millennium Dental Technologies is to be applauded for subjecting the LANAP procedure to such rigorous scientific scrutiny," said Dr. Greenwell. "The multi-centered prospective longitudinal clinical trial will compare [The LANAP protocol] with both surgical and nonsurgical periodontal procedures--an important comparison that will establish the predictability of LANAP relative to extensively tested methods for treating chronic periodontitis."

Dr. Mark Reynolds, director of the University of Maryland portion of the study, noted: "It is rewarding to participate in this landmark study, which will provide important new information on the effectiveness of this innovative therapy."

A previous study was performed by Yukna, with Ronald L. Carr, DDS, and Gerald H. Evans, DDS, documenting clinical and histologic success and achieving FDA clearance for the procedure. The results are available at www.lanap.com/pdf/YuknaArticle.pdf.

More information on the newest study's design is available at clinicaltrials.gov/ct2/show/NCT01282229.

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