Clinical and Translational Research

The primary goal of the Center for Clinical and Translation Research (CCTR) at the Forsyth Institute is to carry out quality integrated clinical translational research. The CCTR team tests ideas and implements innovations in dental and medical care.

The CCTR consists of nationally and internationally renowned scientists and clinicians, who have expertise in clinical and translational research in the dental, craniofacial and biomedical fields. The CCTR team is solely devoted to the administration of patient-oriented research projects.  It is inter-departmental and provides assistance to all principal/co-investigators, and research auxiliary staff at the Forsyth Institute. The CCTR also brings together collaborative partners from National Institute of Health, academia and industry.

Now more than ever, the connections between oral health and overall health are a clear indicator of the importance of the mouth as a gateway to health. Scientific processes are also creating new opportunities for accelerating the movement from basic research in the laboratory to improvements in patient care. Guided by these principals, the CCTR mission is to improve quality of life by advancing oral and overall health care.

Services

The experienced team of clinical research professionals can assist with protocol development, creation of data collection forms, questionnaires, advertisement materials, compliance tools and data entry files in various clinical trial designs including Phase 1, 2, 3 and post marketing studies. Services also include recruitment, screening, consenting and documentation required by the IRB, FDA and the regulatory agencies, monitoring and treatment of research subjects. The CCTR staff is specifically experienced in collection of clinical dental and periodontal data, body measurements, survey administration and collection, blood, saliva, gingival crevicular fluid and dental plaque collection from children and adults. This facility promotes translational research by supporting study implementation and coordination, data management and project regulatory assistance.  Laboratories in close proximity to the clinical facility offer unique capabilities that include:

Microbiological:

  • Semi-quantitative analysis of microbial compositions in biofilm samples in health and disease using Checkerboard DNA-DNA hybridization technique
  • High-throughput Illumina sequencing of nearly 600 oral bacterial taxa at species level in addition to sequencing of 129 genera at health and disease using Human Oral Microbial Identification using Next Generation Sequencing (HOMINGS) technique
  • Rapid microbial and eukaryotic sequence applications including exomes, genomes and transcriptomes for both mammalian and microbial models, target RNA expression studies and amplicon-based sequencing analysis using 2 MiSeq and 1 NextSeq DNA Sequencers
  • Utilization of Human Oral Microbial Database (HOMD) and bioinformatics

Immunological:

  • High throughput analysis of cytokines, chemokines, hormones and enzymes in various biological fluids including serum, plasma, saliva, and gingival crevicular fluid using BioRad Luminex 100/200 and recently BioRad FLEXMAP 3D System
  • Analysis of lipids, various antibodies and proteins using ELISA
  • Analysis of cell-based events and molecular fingerprints of pathways that play role in diseases and health using cellular and molecular assays

Histopathological:

  • Histopathological assessments of human specimens using various techniques - chair side soft and hard tissue biopsy obtaining, analysis of paraffin embedded and microtome sectioned or cryo-sectioned specimens using histopathological and immunohistochemical techniques. 
  • Imaging using Zeiss AXIO Observer Inverted Microscope and Zeiss LSM 780 Microscope

Proteomics/Lipidomics:

In collaboration with CCTR, Forsyth’s Salivary Diagnostics Center offer screening tools for biomarkers for various clinical conditions including, periodontitis, diabetes, cardiovascular disease, obesity, metabolic syndrome, rheumatoid arthritis, oral cancers and many others.  The center is equipped with:

  • AB Sciex 4800 Plus MALDI TOF/TOF
  • Thermo Scientific QExactive Plus
  • Thermo Scientific Orbitrap Fusion
  • AB Sciex 6500 QTRAP LC/MS/MS System
  • AB Sciex 6600 Triple TOF System
  • Saliva Biobank- Storage facility for preservation of bar coded samples at –80oC;
  • Tecan robotics for analytic assays

Structure

The CCTR consists of professional staff including: dentists, periodontists, pediatric dentists, orthodontists, endodontists, prosthodontists, dental hygienists, dental assistants, statisticians, microbiologists, immunologists, molecular geneticists, laboratory technicians, administrative team and subject recruitment specialists.

The trained and calibrated team have experience in conducting Phase I, II, III and IV level FDA clinical trials in the areas of: oral hygiene, periodontology, cariology, dental plaque pH, drug delivery, anesthetics, oral cancer, and systemic health

All clinical trials are approved by the Forsyth Intuitional Review Board and conducted under Good Clinical Practice guidelines and meet all current regulatory requirements. The clinic offers a state-of-art modern facility that includes:

  • Private six chair clinical facility accommodates all types of study procedures
  • Large patient database with varied subject populations
  • Private consultation room
  • Conference room with video conferencing capacity
  • Cone-Beam Computed Tomography for bone and implant research
  • Chair-side electronic data entry
  • Chair-side digital radiography
  • Sterilization area with clean room and supply storage capacity
  • Processing laboratory for a wide-array of human samples and freezer room for long term storage
  • Research agreement with a diagnostic, CLIA certified outside laboratory for safety analysis

Administrative Team

  • Thomas E. Van Dyke, DDS., Ph.D., Vice Chair of Clinical Research
  • Hatice Hasturk, DDS., Ph.D.-Director
  • Marie Letteri, EMS-Clinic Manager
  • Constantinos Floros, Study Coordinator
  • Debbie Rider, RDH - Administrator, Institutional Review Board
  • Kathy Eklund, RDH, Chair of Institutional Review Board

Clinical Team and Area of Expertise

Principal Investigators

  • Floyd Dewhirst; Microbiology
  • Hatice Hasturk; Periodontology, Inflammation, Treatment of Periodontal Disease, Oral & Systemic Health and Diseases
  • Alp Kantarci; Periodontology, Inflammation, Biomarkers of Oral and Systemic diseases
  • Bruce Paster; Microbiology, Molecular Genetics
  • Pramod Soparkar; Dental caries, Epidemiology, Clinical indices
  • Mary Tavares; Public Health, Epidemiology, Childhood Obesity and Nutrition
  • Thomas Van Dyke; Periodontology, Inflammation, Systemic Health

Current Clinical Staff

  • Hernide Deribert, Dental Assistant-chair side data entry
  • Molly Dunne, Patient Recruitment Specialist- Phone screening
  • Constantinos Floros, Research Assistant-Data Manager
  • Marie Letteri, Emergency Medical Services, Patient Coordinator
  • Melissa Martins; Dental Hygienist, Clinical Study Coordinator-Data and sample collection-processing
  • Elida Salazar; Dental Hygienist, Clinical Study Coordinator-Data and sample collection-processing
  • Homa Sherzai; Dental Hygienist, Clinical Study Coordinator-Data and sample collection-processing
  • Nicole Tejeda, Dental Hygienist, Pharmacy Technician, Study Examiner-Data and sample collection-processing
  • Gay Torresyap; Dental Hygienist, Clinical Study Coordinator-Data and sample collection-processing
  • Maria Iacommaci, Dental Assistant-Chair side data entry

Current Laboratory Staff

  • Daniel Nguyen, Lead Research Technician, Manager of Flow Cytometry Core, cellular assays, histology, microCT, animal research
  • Michele Patel, Research technician, microbiology
  • Danielle Stephens, Manager, Luminex Core, cellular assays

Current Postdoctoral Fellows, Students and Interns

  • Alaa Ahmed, DDS, HSDM DMSc Student
  • Nadine Almpani, DDS, Visiting Research Scholar
  • Nada Alshehri, DDS., BUSDM DSc Student
  • Erin Breen, DDS., HSDM, Visiting Student Intern
  • Corneliu Sima, DDS, PhD, Postdoctoral Fellow

 

 

 

 

Current Ongoing Studies

  • Mechanisms in the link between periodontal disease and diabetes
  • Mechanisms involved in localized aggressive periodontal disease
  • Identification of uncultivable oral pathogens that may play important roles in health and disease
  • Effect of novel products on periodontal health, tissue and bone regeneration
  • Testing novel chair side diagnostics for diabetes