College of Dentistry | University of Florida

Facilities

Patient at PDRCThe University of Florida Periodontal Disease Research Center (PDRC) has an established record in the performance of state-of-the-art clinical research in the development and evaluation of oral health care products. Recent investigations have involved clinical studies of anti-inflammatory products, growth factors in periodontal regeneration, clinical and microbial evaluations of both systemic and locally delivered antibiotics, antimicrobials and antiseptic agents in mouth rinses and dentifrices. Also, we perform in vitro studies of antimicrobial compounds, in vitro susceptibility studies, and test diagnostic methods and procedures.

The PDRC has the capability to conduct Phase I, II, and III trials, complete with microbial evaluations and statistical analyses. PDRC investigators carry out clinical trials in the Clinical Research Center and scientific laboratories at the College of Dentistry in Gainesville, Florida. Our clinical and laboratory staff is knowledgeable and experienced in the fields of periodontology, hypersensitivity, pharmacology, immunology, microbiology, and statistics.

The PDRC also has laboratory facilities available for conducting small scale pilot studies and/or for determining the effects of various compounds on the oral flora.

Resources:

  • Dedicated clinical research area:
    • 5 fully equipped dental operatories
    • Computerized data entry
    • Dental laboratory
    • Radiography, standard and digital
    • Up to five on-site Good Clinical Practice certified coordinators
    • Extensive subject database
    • Knowledgeable and certified staff
  • Unsurpassed microbiology capabilities:
    • Computerized bacterial and yeast identifications.
    • DNA-DNA hybridization
    • Cultivation and identification of anaerobic and facultative bacteria
    • Antimicrobial sensitivity testing
  • Secure and confidential product and data handling and storage
  • Health Science Center Institutional Review Board
  • Western Institutional Review Board proficient
  • Established SOP’s concordant with the FDA and European guidelines for GCP and GLP standards
  • Experienced investigators and calibrated examiners

Capabilities

  • Design and conduct of short and long-term clinical trials
    • Safety and Efficacy
    • Pharmacokinetics
    • Claim support
    • Diagnostic methodology
    • Calibration exercises
    • ADA/FDA guidelines
  • Subject panels available
    • Periodontitis
    • Gingivitis
    • Hypersensitivity
    • Calculus
    • Plaque
    • Stain
    • Caries
    • Whitening (bleaching)
  • Microbiology
    • Microbial sampling
    • Bacterial culture and identification
    • Antimicrobial susceptibilities
    • Safety and efficacy evaluations
    • Microscopic and culture enumeration
    • DNA-DNA Checkerboard hybridization
  • Data collection / management / analysis
    • Continuous quality control
    • Standard and electronic chair-side data entry
    • Data provision
    • Statistical testing and analyses
    • Clinical and microbial data integration
  • Specialized Reports
    • Preparation of final report for Corporate Sponsor, ADA or FDA submission
    • Preparation and presentation of scientific abstracts
    • Preparation and presentation of scientific manuscripts
  • Other services available (please inquire)

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