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Dentistry's Bluestone Center Invites You to Have "A Marvelous Experience"

The Blue Stone Center
“It was a wonderful, a marvelous experience,” said Zelda Brand, “I recommend it for anyone.” Ms. Brand was describing her participation in a clinical trial conducted at the Bluestone Center for Clinical Research, part of the NYU College of Dentistry. The Bluestone Center for Clinical Research is the largest dental-school based facility in the United States built specifically to investigate promising new medical and dental treatments before they are available on the market. Ms. Brand was referred to the Bluestone Center by her radiologist following cancer surgery and radiation that resulted in the removal of her vocal cords and the loss of use of her salivary glands. At the Bluestone Center she was given a new medication and carefully monitored to see if it would enable her to regain her ability to salivate. It did.

In addition to being the largest center of its kind in the nation, the 8,500 square-foot Bluestone Center is also the only one with bedrooms for patients who have to be closely monitored overnight. While the vast majority of the clinical trials do not require an overnight stay, patients who do stay overnight at the Bluestone Center can expect a room with private bath and shower, cable TV and Internet access, plus whatever they want to eat. If it’s available at a Manhattan deli or a restaurant that delivers, the staff will try to comply with all menu requests. This is a staff that works hard to be welcoming and to make participants feel like they are part of the research team. The result is a very personalized, nurturing, patient-centered environment that is more homey than hospital-like.

“The only way to develop safe new drugs for patients is to test them in a controlled environment in accord with the strictest government regulations and ethical guidelines,” says Dr. Jonathan Ship, Director of the Bluestone Center for Clinical Research. “Our strategy is to combine academic excellence with industry’s efficiency and speed. In order to do that, we must aggressively market participation in clinical research. But we always stay focused on the needs and desires of individual patients.”
At the Bluestone Center for Clinical Research, a team of physicians, dentists, nurses, and specially-trained clinical research coordinators from the NYU College of Dentistry, the College of Nursing and the School of Medicine conducts outpatient and overnight Phase I – IV research studies in a wide range of medical and dental areas. Each phase answers different questions about the new treatment.

Medical trials include analgesics, anti-inflammatory drugs, sedatives, cancer therapy, sleep apnea medications, anxiolytics, and dermatology products. Oral health trials might consider new dental devices and restorative materials, dry mouth and mucositis, oral lesions and cancer, periodontitis, implants, dental caries, whitening and anti-plaque products, and oral facial pain.

In Phase I studies, researchers look for the best way and how frequently to safely administer a new treatment; e.g., by mouth, IV drip, or injection. They also watch for any harmful side effects. Because less is known about the possible risks and benefits in Phase I, these studies usually include a limited number of subjects, between 15 and 30, who would not be helped by existing treatment therapies.

Phase II trials continue to test the safety of the new treatment, and begin to evaluate how well it works against a specific disease. As in Phase I, only a small number of people (usually less than 100) take part. When a Phase II trial begins, it is not yet known if the agent being tested works against the specific disease being studied.

Phase III trials focus on how a new treatment compares to standard treatment. In most cases, studies move into Phase III testing only after a treatment shows safety and efficacy in Phases I and II. Phase III trials may include hundreds to thousands of people at many clinical centers. In Phase III trials, people are assigned at random to receive either the new treatment or standard treatment.

Phase IV trials are used to further evaluate the long-term safety and effectiveness of a treatment. Less common than Phase I, II, and III trials, Phase IV trials usually take place after the new treatment has been approved for standard use.

“In addition to receiving special attention for a medical or dental condition, participating in Bluestone Center clinical trials offers patients an excellent way to understand clinical research,” says Dr. Ship. “It also provides an opportunity to help others who may be suffering from a common or rare disease or illness, now or in the future. As promising new treatments arise, the Bluestone Center is dedicated to making sure that NYU community members are the first to know about them. We think that the Bluestone Center is an important resource for society in general and for a community of learners like NYU in particular.”

Sidebar or Box:
You May Be Eligible To Participate in a Bluestone Center Clinical Research Study
Do You Have Sensitive Teeth?
The Bluestone Center is currently recruiting adults ages 18-65 for a sensitive teeth study. If you have at least three teeth that are sensitive to cold and touch, you may be eligible to participate in a study comparing two different products to see if they make your teeth less sensitive. If you are eligible, your treatment will be provided at no cost and you will be compensated for your time. The trial requires five visits over a one-year period and you will be compensated $25 for each visit. Please call 212.998.9310 for more information.

Do You Smoke or Drink?
The Bluestone Center is looking for men and women ages 45 and older who consider themselves heavy smokers and/or drinkers to participate in a study to test a new method of identifying people who are at risk to develop oral cancer.Eligible applicants will be compensated $35 per visit for up to two visits over a three-week period. For more information, please call 212.998.9310.

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