Therapeutic Focus: Dental

Rho has extensive experience with dental clinical trials

Our extensive experience conducting dental clinical trials includes over 50 dental studies working with more than 250 sites and enrolling more than 25,000 subjects. Some advantages of working with Rho on your dental trial:

• Experience in federally funded and commercially funded dental trials, including our role as the Clinical Research Operations and Management Support (CROMS) provider for the National Institutes of Health (NIH) National Institute of Dental and Craniofacial Research (NIDCR)
• Strong site relationships
• On-staff dentist and dental hygienist
• In-depth understanding of the unique challenges of dental trials, such as:
  • Managing the high volumes of dental samples typical of dental trials
  • Developing executable dental protocols based on knowledge of working practices in dental clinics
• Experience using advanced statistical methods to:
  • Account for multiple levels of statistical correlation, such as correlations between surfaces on a tooth, teeth within a subject, and subjects within a clinic
  • Analyze measurements of dental disease repeated through time
  • Handle missing data cause by the loss of a tooth during a trial or the loss of a subject to follow-up
• Extensive electronic data capture (EDC) experience in dental trials, including:
  • Designing electronic case report forms (eCRFs) that can accomodate the large number of data fields required for a periodontal examination
  • Designing systems that can make instantaneous calculations of changes in measures of periodontal disease from a previous examination and alert the examiner to significant changes

Meet Our Experts

Senior Research Scientist

In addition to being a licensed dentist, this Senior Research Scientist received a PhD in Oral Epidemiology and MPH in Health Policy and Administration from the University of North Carolina at Chapel Hill (UNC).  He has published over 30 articles in peer-reviewed journals and serves as a reviewer for several notable journals.  His scientific expertise combined with clinical experience allows him to provide important insight into dental clinical trials.  He has served as principal investigator on several large, multi-center, federally funded projects and is currently an adjunct professor at the UNC School of Dentistry.

Senior Study Coordinator

This Senior Study Coordinator is a licensed dental hygienist with more than 15 years of research experience.  She applies her practical working knowledge as a dental hygienist to develop protocols that are easy to operationalize and execute.  She has published multiple articles, serves as a reviewer for peer-reviewed journals, and currently holds an adjunct faculty appointment at the UNC School of Dentistry.

Dental Trial Problem Solving

A recent trial required collection of more than 700,000 lab specimens.  To meet this need, we integrated RhoLAB, our proprietary laboratory tracking system, with Medidata’s RAVE EDC to automate the transfer of specimen tracking information between systems.  As a result, the project team was able to ensure accuracy in specimen tracking while simultaneously decreasing the impact handling so many specimens would have on clinical staff.

Rho has experience in a range of dental and craniofacial indications including:

• Behavioral interventions
• Craniosynostosis
• Taste sensitivity
• Periodontal surgery
• Fluoride exposure
• Oral mucositis
• Cleft palate
• Craniofacial microsomia
• Dry mouth
• Teeth whitening
• Periodontal infections/gingivitis
• Dental plaque
• Oral irritation and sensitization
• Dental caries
• Oral wound healing
• Temporomandibular disorder
• Salivary gland dysfunction
• Oral cancer
• Sjögren's syndrome

Download PDF