Dental

Of all the acute pain models one can choose from, dental pain has been shown to have the greatest assay sensitivity, fastest recruitment, and the lowest cost.

Lotus Clinical Research is an ideal choice for dental pain (third molar extraction) studies, not only due to our capabilities in the dental model itself, but also for our ability to advise and conduct later phase studies.

Most sponsors who are involved with dental pain programs are planning their Phase IIb and Phase III programs. This planning process necessitates strategic decision making and regulatory correspondence. Having Lotus Clinical Research on board during this critical early period is of significant value.

For dental trials, Lotus Clinical Research provides both CRO and site services. We can perform single-center dental studies within our own walls, and also utilize a network of well-vetted sites throughout the country for multicenter investigations.

 

Minimizing Variability

The key to success in dental surgery is minimization of variability, which can be achieved by:

  • Ensuring that all sites appropriately identify impaction levels
  • Utilizing a pre-specified impaction grading scale
  • Homogenizing and adhering to a standard anesthetic regimen
  • Placebo response training for subjects and staff members

 

Subject Recruitment

With 17 million people in the greater Los Angeles area and proximity to six local colleges, recruitment into dental studies at the Lotus Clinical Research dental site is swift and reliable. Additionally, Los Angeles provides a diverse ethnic group, which is an important component of early phase research.

Our recruiting team consists of multiple full-time call center operators, a call center manager, and a media buyer. They achieve excellent results by utilizing our in-house database, social media, and newspaper/radio advertisements.

 

Dental Facilities

Lotus Clinical Research utilizes a board-certified, oral-maxillofacial surgeon to perform the extractions. The surgical suite is outfitted with state-of-the-art equipment, including a digital panoramic x-ray system (good visualization is critical for determining impaction level).

 

Enrollment

Average enrollment is 30+ subjects per month at the Lotus Clinical Research site. Screen failure rates average from 25-30% based on specific inclusion/exclusion criteria and dental x-rays.