FDA approves laser cavity fix, promising less painful dentistry

WASHINGTON (AP) — Americans who dread the dentist's drill may get less painful dental visits. The government approved the nation's first laser to repair cavities Wednesday — and the vast majority of patients who tested it didn’t require anesthesia.

"I've always been scared of dentists," said Harry Chulamanis of West Millford,: NJ, who had two large cavities filled with the laser. But "I was astounded. There was no pain at all."

Calling the system: "medicine for the 21st century," the Food and Drug Administration on Wednesday approved Premier Laser; Systems erbium-YAG laser for treating tooth decay. The Irvine, Calif.-based company says the laser is appropriate for many of the:170 million cavities filled annually in the United States:

Dentists already had some lower powered lasers for use on gums and other soft mouth tissues. But no laser has been allowed directly on teeth until now because of fears the high heat would damage the inner core of a tooth, explained Dr. Susan Runner, FDA's chief of Dental devices.

Premier's laser "has the potential for changing the way dental practice is handled in this country," Runner said.

The FDA examined studies of over 600 teeth to declare the laser as safe and effective as a drill. It appeared to cause no side effects, and the laser patients’ fillings last as long as fillings in teeth that were drilled, Runner said. The only two limitations: --The FDA forbade doctors from using the laser on children. The agency is concerned because teeh’s sensitive inner "pulp" forms a larger part of the tooth in children and thus might be penetrated by the laser, Runner said. But Premier said it has seen no problems so far in the experimental testing of 80 children over age 2.

--Patients and Dentists must wear goggles during treatment to protect their eyes from the intense light beam.

The laser removes a cavity without the pressure and vibration of a: drill, explained Premier chief executive Colette Cozean.:

In total testing: of over 1,300 teeth, only three patients requested local anesthesia she said. The FDA cautioned that other patients did report some mild discomfort.

But the pain reduction means many patients won't need either to have an injection or to leave the dentist's office with a mouth numb from Novocain, said Cozean,: who had the laser repair two of her teeth without anesthesia. That also cuts off the procedure about 20 minutes per tooth spent waiting for the pain killer to take effect, she added.

The laser also can make a smaller hole than a drill, thus requiring; a smaller filling, Cozean said.

And there is some research—albeit not proof—that indicates a laser might kill the underlying bacteria that caused the cavity so decay doesn't continue and force the filling to eventually fall out, she said.

Dentists also are studying whether lasers might one day make root canals and other surgeries less painful, FDA's Runner said.

WASHINGTON (CNN) -- Good news for those who dread the dentist's drill: The Food and Drug Administration on Wednesday approved the use of a laser for treating tooth decay.

In studies, the laser was as safe and effective as a high-speed drill in removing tooth decay and preparing a tooth for a filling.

Lasers have previously been approved only for use on soft tissue, such as the gums.

"Use of lasers in dentistry is medicine for the 21st century. They will give dentists and patients a significant new option for treating decay," said the FDA's Bruce Burlington.

Currently, only five dentists in the United States have this laser. The manufacturer says it's widely available in Europe and will be widely available in the United States in 90 days.

Dentists will need special training before using the laser. Some estimate it will be a couple of years before most patients have access to it.

Premier Laser receives FDA clearance to market Centauri Er:YAG system for hard tissue applications; first in nation.

IRVINE, Calif.--May 7, 1997-- Premier Laser Systems Inc. (NASDAQ/NM:PLSIA) Wednesday announced that the FDA has granted the company the first-ever clearance to market a laser system throughout the United States for a new dimension in dentistry -- hard tissue procedures, including caries (decayed tissue) removal, cavity preparation and related applications.

The clearance was granted to Premier Laser for its Centauri™ Erbium Yttrium Aluminum Garnet (Er:YAG) laser system. With an estimated 170 million hard tissue procedures performed annually nationwide, the company believes it may sell as many as 10,000 to 15,000 ErYAG systems for those applications within the next decade. The system will cost approximately $39,000. Shipments will begin later this quarter; systems will be in dentists' hands within the next 90 days.

Premier Laser Chairman, President and Chief Executive Officer Colette Cozean, Ph.D., said that clinicians in five states had developed data on more than 1,300 procedures for the final submittal to the Food and Drug Administration.

"Extensive pre-clinical and clinical studies, with a three-year follow-up, have shown that Centauri's overall performance and safety offer patient comfort and other significant advantages when compared with the traditional high-speed drill," she commented.

"We're especially proud to be the first company in the nation to receive this clearance," Cozean added. "Centauri completes our product line, which already features leading dental laser systems for soft tissue surgery and teeth whitening. We believe this new application will play a key role in the expansion of our marketing and distribution outside the U.S."

Richard T. Hansen, DMD, a Fullerton, Calif-based practitioner and faculty member at the University of California at Los Angeles (UCLA) School of Dentistry, participated in the clinical tests. He said the results of his and other patient studies "underscored the fact that a laser for hard tissue procedure writes a new page in dental history. I believe it's a development patients have been waiting for, especially considering the public's familiarity with the success of medical lasers."

Hansen pointed to a number of practitioner benefits provided by the laser system. "We can pinpoint and excise diseased hard tissue with great precision, preserving the tooth's overall integrity," he said. "We can eliminate nonproductive time spent during the day waiting for anesthesia to take effect and we find the laser ideal for the newer tooth-colored restorative materials dentists increasingly use."

He added that, based on his and other practitioners' previous experiences with laser systems, the practice usually expands measurably, primarily by patient referrals. Hansen indicated that the Er:YAG laser system is already cleared for periodontal applications and that there is a possibility of future clearances "that might permit a variety of other applications, including root canal surgery and the cutting and shaping of bone.

Hansen's comments were echoed by James M. Pelagalli, DDS, founder of the Cleveland-based American Academy of High-Tech Dentistry and chief clinical investigator. "There are also several patient advantages," he commented. "There's little or no pain and minimal discomfort, so in most cases there's no need for anesthesia or needles. The patient won't hear a high-speed drill, or feel its vibrations.

"My own clinical experience has clearly shown that the Er:YAG becomes a fascinating, even friendly instrument," Pelagalli said. "Now a trip to the dentist should no longer be fearsome for this or future generations."

Cozean herself underwent hard tissue procedure as part of the clinical testing. "I personally experienced the speed and ease with which the laser removed the decay, with no pain whatsoever," she said.

Cozean indicated that all practitioners choosing to purchase the Centauri will be required to undergo an intensive training program and will be provided continuing clinical updates via printed case studies and videotapes from the clinical testing participants and other dentists employing the system. Registration for training courses will begin immediately.

Requests for course information may be sent via e-mail: premier@pacbell.net

Premier Laser Systems develops, manufactures and markets several lines of proprietary medical and dental lasers, fiber optic delivery systems and associated products for a variety of dental, ophthalmic, surgical and dermatological applications. The Centauri was previously cleared to market by the FDA for certain ophthalmic surgery applications.