Fall 2004 Table of Contents
     
Research in Focus
Advancing the Clinical Research Mission: Bluestone Center Marks Two-Year Anniversary
 

 

 

 

 

 

 

 

 


 

 

 

 

 

 

 

 



Since its opening in November 2002, the Bluestone Center for Clinical Research has conducted nearly three dozen studies in areas ranging from new head and neck cancer treatments to dental implants to the management of hyperglycemia in diabetics with periodontal disease. A complete list of trials appears on pages 50 - 51.

According to the Bluestone Center’s Director, Dr. Jonathan Ship, a Professor of Basic Science and Craniofacial Biology and of Oral Medicine at NYUCD, and a Professor of Medicine at the NYU School of Medicine: “Industry has responded positively to our model of intellectual manpower minus the bureaucracy traditionally associated with academic research, awarding $3.5 million in grants in under two years. As a result, we are well positioned for new growth, particularly in Phase I-IV trials and the development of new drug applications.”

At over 8,500 square feet, the Bluestone Center is the largest clinical research center in a dental school and the only one with overnight facilities for patients participating in 24-72 hour clinical studies. In the past two years, the center has recruited a pharmacotherapy research chief and four new clinical research coordinators, creating a breadth and depth of talent and experience for the conduct of both dental and medical research sponsored by both industry and federal agencies such as NIH/NIDCR.

Dr. Frederick A. Curro, Chief of Pharmacotherapeutic Research, cites the fact that the Bluestone Center offers a full spectrum of regulatory services for drug development as a major draw. Dr. Curro has been responsible for an increase in awards from small biotechnology companies to develop and execute Phase I-IV trials and FDA submissions.

A total of five clinical research coordinators are cross-trained to participate in multiple trials simultaneously. Three of the coordinators are certified by the Association of Clinical Research Professionals and the other two will soon complete their certification. One coordinator is working primarily on trials involving oncology research faculty collaborators from nearby Beth Israel Hospital Medical Center.

Bluestone Center’s Executive Administrator, Rene Lopez, who is responsible for contract negotiation, quality assurance, and overall administrative functions, notes that “Before we opened, a quick turnaround time for contracts was two weeks; now, with a single contact person and the inroads that we have established with the NYUSM Office of Clinical Trials — we can complete a contract in as little as 24 hours. For example, when one sponsor called to say they had a tight deadline for commissioning new research, we completed the contract in a day.”

Negotiations are currently underway to bring more than 15 new Phase I-IV clinical trials and drug development projects to the Bluestone Center. Dr. Ship said that the growth in part reflected the faculty’s growing familiarity with and eagerness to use the facility. “We have worked hard to integrate Bluestone into NYUCD’s culture and have provided faculty-to-faculty training in Good Clinical Practice guidelines, clinical research standards, and clinical trial development and conduct,” he said. He added that the Bluestone Center would be able to accommodate future growth by tapping into the graduating classes of NYUCD’s MS degree and Certificate Programs in Clinical Research, which use Bluestone’s facilities to train their students. In fact, one of Bluestone’s research coordinators, Dr. Hanae Saito, was one of the first two graduates of the MS in Clinical Research program, and another coordinator, Concetta Mangiaracina, received a Certificate in Clinical Research and is studying part-time for her MS degree.

Dr. Ship said he expected that Bluestone would also increasingly tap into faculty from other institutions for collaborative research ventures. Dr. Ship’s appointment as a Professor of Medicine at the NYU School of Medicine is expected to increase cooperation with clinical researchers there. “At the same time,” Dr. Ship added, “internationally recognized researchers who joined NYUCD’s faculty in the past few years are making connections for us at colleges overseas. We are only beginning to tap into our full potential to make an impact on oral health worldwide.”

Industry- and NIH-Sponsored Studies Awarded to the Bluestone Center for Clinical Research from November 2002-August 2004*

Oral Medicine

 

Study Title

Investigators**

Clinical Evaluation of a New Technique for Detecting Suspicious Oral Lesions with Oral Speculoscopy

A. Ross Kerr (PI), Miriam R. Robbins, David A. Sirois, Silvia E. Spivakovsky, William C. Ullman

Efficacy & Side Effects of the Topical Application of a Novel Agent in the Treatment of Minor Aphthous Ulcers

A. Ross Kerr (PI)

 

Women's Interagency HIV Study (WIHS)

Joan Phelan (PI)

Open-Label, Dose-Escalation, Phase I Clinical Study to Assess the Safety of a Novel Agent in Patients with “Pemphigus Vulgaris” Requiring Daily Corticosteroid Therapy

Bruce Strober1 (PI), Jonathan A. Ship

Phase III, Double-Blind Trial of a Novel Agent in Post-Radiation Therapy Patients with Xerostomia

Jonathan A. Ship (PI)

Phase III, Open-Label, Long-Term Safety Study of a Novel Agent for Xerostomia

Jonathan A. Ship (PI)

High-Dose Rate Intraoperative Radiation for the Management of Metastatic Squamous Cell Cancer

Kenneth Hu2 (PI), Jonathan A. Ship

Phase II, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study of the Effects of a Novel Agent on Oral Mucositis

Kenneth Hu2 (PI), Jonathan A. Ship

Phase III, Randomized, Multicenter, Placebo-Controlled Study of a Novel Agent for Oral Mucositis

Kenneth Hu2 (PI), Jonathan A. Ship

Chemoradiation, Neck Intraoperative Radiation Therapy, and a Novel Agent for Head and Neck Cancer with High-Risk Neck Disease

Kenneth Hu2 (PI), Jonathan A. Ship

A Randomized, Observer-Blind, Cross-Over Design Study Comparing the Effects of Two Commercial Non-Prescription Mouth Rinses on Salivary Flow Rates and Xerostomia

Jonathan A. Ship (PI), Ronald Katz, A. Ross Kerr, Jane A. McCutcheon

Protocol Development for Phase III Study of a Novel Agent for Xerostomia

Jonathan A. Ship (PI), A. Ross Kerr, Jane A. McCutcheon

Prospective, Double-Blind, Placebo-Controlled, Multicenter Trial to Assess the Efficacy and Safety of a Novel Agent for “Pemphigus Vulgaris”

David A. Sirois (PI), A. Ross Kerr, Miriam R. Robbins, Jonathan A. Ship

Oral Cancer Detection: Current and Emerging Technologies

David A. Sirois (PI), A. Ross Kerr, Miriam R. Robbins

   

Periodontics

 

Pilot Study of a Novel Agent: Effects of Glycemic Control in Subjects with Type 2 Diabetes and Chronic Periodontitis

Ron G. Craig (PI), Angela R. Kamer, Eva M. Lupovici

Periodontal Assessment and Rheumatology Arthritis Study (PARAS)

Clifton Bingham1 (PI), Ron G. Craig, Angela R. Kamer, Denise Estafan, Khalid Almas, Jonathan Ship

Periodontal Disease and Prematurity

Ananda Dasanayake, Ronald Craig, Douglas Morse

Calibration Study of Two Commercially Available Dentrifice Formulations on the Prevention of Gingivitis and Plaque Formation

Bapanaiah Penugonda (PI), Diana L. Galvis

IND Development for a Novel Agent for Gingivitis

Frederick A. Curro (PI), Ron G. Craig, Jane A. McCutcheon

   

Implants

 

Study to Compare A Non-Traditional Implant System vs. Two Traditional Implant Systems with Regard to Changes in Marginal Bone Level

Nicholas Elian (PI), Stuart Froum, Dennis P. Tarnow , Stephen S. Wallace, Sang-Choon Cho, Ziad Jalbout

Clinical Comparison of Healing Extraction Sockets Following Implantation of a Xenograft Absorbable Bone Graft With or Without an Absorbable Membrane Barrier

Stuart Froum (PI), Dennis P. Tarnow, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho, Ziad Jalbout

Post-Approval Study for Evaluation of a Novel Agent for Periodontal Disease After Multiple Treatments

Stuart Froum (PI), Dennis P. Tarnow, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho, Ziad Jalbout

Histological Comparison of an Allograft to an Organic Bovine Bone Mineral in Maxillary Sinus Grafting

Stuart Froum (PI), Dennis P. Tarnow, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho, Ziad Jalbout

Open, Randomized Study to Compare Two Dental Implant Systems with Regard to Changes in Marginal Bone Level

Dennis P. Tarnow (PI), Stuart Froum, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho, Ziad Jalbout

Protocol Development of Comparative Efficacy of a Non-Traditional Implant vs. a Traditional Implant

Farhad Vahidi (PI), Van P. Thompson

Survival Rate of Novel Direct One Piece Dental Implants When Placed With a Flapless or Flap Protocol

Dennis P. Tarnow (PI), Stuart Froum, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho, Ziad Jalbout

Histomorphometric Comparison of Two Materials in Maxillary Sinus Grafting

Dennis P. Tarnow (PI), Stuart Froum, Nicholas Elian, Stephen S. Wallace, Sang-Choon Cho, Ziad Jalbout

   

Pain

 

IND Clinical Development Plan for a Novel Agent for Post-Operative Dental Pain

Frederick A. Curro (PI), Robert S. Glickman, Jane A. McCutcheon

Dose Response Study on a Novel Agent for Toothache

Jonathan A. Ship (PI), Silvia E. Spivakovsky, Stanley N. Turetzky

Phase III, Randomized, Multicenter, Parallel-Group, Double-Masked, Placebo-Controlled Study of the Safety and Efficacy of a Novel Agent in the Treatment of Post-Operative Dental Pain

Robert S. Glickman (PI), Kenneth E. Fleisher

Phase III, Double-Blind, Randomized, Placebo-Controlled Study of the Effect of a Novel Agent on the Rate of Recovery from Soft-Tissue Anesthesia and on Safety in Dental Patients

Andrea S. Schreiber (PI), Eva M. Lupovici, Kenneth L. Allen

   

Restorative

 

Open-Label Clinical Study of a Novel Bur on Class I Carious Lesions

Kenneth L. Allen (PI), Gerald Klaczany, James T. LoPresti, Van P. Thompson

Microbial Diversity and Characterization of Cariogenic Biota

Page Caufield (PI), Ananda Dasanayake, Yihong Li

Clinical Evaluation of A Novel Composite Resin and Two Novel Bonding Resins

Benjamin Godder (PI), James T. LoPresti, Gerald Klaczany, Van P. Thompson, Douglas Pollack, Robert Blashka

Single-Blind Clinical Study of Polymer Dentin Removal Burs on Class V Carious Lesions

James T. LoPresti (PI), Kenneth L. Allen, Gerald Klaczany, Van P. Thompson

   

Aesthetics

 

Single-Blind Study of the Efficacy and Sensitivity of Four Dental Whitening Systems

Ivy Peltz (PI), Eric S. Studley, Evelyn A. Nelson, Andrew B. Schenkel, Arnold Rosenstock, Jay W. Schwarz

Clinical-Efficacy Determination of Prototype Liquid Whitener

Bapanaiah Penugonda (PI)

Extrinsic Stain Removal by Chewing Gum

Warren I. Scherer (PI), Alan H. Rattet, Harry G. Meeker

   

Prosthodontics

 

Implant Overdenture Prospective Study

Leila Jahangiri (PI)

   

Epidemiology and Behavioral Science

 

Dental Alliances to Reduce Tobacco (DART)

Gustavo Cruz (PI)

   

Education

 

The Effect of an Interactive CD and the Use of Chewing Gum on Learning Dental Anatomy

Kenneth L. Allen (PI), Ralph V. Katz

Notes
* Over 15 Phase I-IV clinical trials and IND development projects in a variety of fields are currently in the contract and budget negotiation phase.
** All investigators are NYUCD faculty unless otherwise noted.
1 NYU School of Medicine faculty
2 Beth Israel Hospital Medical Center faculty