RESEARCH FACULTY INITIATIVE

Precision Dentistry is all about patient-centered care. It incorporates personalized dentistry into a dental management model that utilizes technologic advances available. Access to lasers, scanning technology, 3D-printing and advanced chemistry formulation development makes a reality the customization of dental/oral care, as well as systemic disease risk, with clinical decisions, practices, and/or products formulated for the needs of the individual patient.

CLINICAL FACULTY APPLICATION

PhytoDental Solutions, Inc. (PDS) is currently recruiting DDS to function as PIs to participate in Virtual Clinical Trials to validate safety and efficacy of Multiple Use Specific Formulations (MUFs) as they move from the laboratories to the dental offices.

In recruiting dentists to join the Clinical Research Faculty, PDS is committed to developing a Real World Dental Clinical Study Network (RWDCSN). This national network is to consist of up to 100 actively participating PDS Clinical Research Sites. To accomplish this, PDS is recruiting dentists to join the Clinical Research Faculty. Following successful review of their applications, the practice site dentists will be recognized as Principal Investigators (PIs) following completion of training and education by completing:

1. NIH Human Subject Protection Lessons 1, 2 and 3 (for details please refer to NIH site https://www.hhs.gov/ohrp/education-and-outreach/human-research-protection-training/human-research-protection-foundational-training/index.html); 
2. Educational information units specifically developed for the practice inclusion of phytocannabinoid formulations designed products by PDS and authorized by its Dental Advisory Board.

PDS Clinical Faculty involved in our RWDCSN going forward will provide a real-time, real-world pool of patients instantly accessible for case, pilot and ultimately our plans include FDA registration designed clinical validation and safety studies on subsequent PDS ISF formulations under development. 

Participants will gain early access to PDS’s novel plant-based cannabinoid formulations first through participating in IRB designed and approved studies and secondly initial commercial production limited runs of current and future products. 

Our first Virtual Clinical Trial will be an expanded study of our previous clinical study of our Patient Comfort Formulation (references 1 and 2). The test formulation and all materials will be supplied free of charge for participation. Following participation in the trial participating DDS practices will enjoy the benefit of heavily discounted Patient Comfort pricing for their practice. Clinical protocols, patient requirements, consenting forms as well as all other trial study documents will be provided and followed electronically by PDS staff of dental hygienists who are undergoing training to be accredited Clinical Research Associates (CRA) and Coordinators (CRC). 

Patient cohorts per practice will be limited to no more than 5-10 patients per study thereby minimizing interruption of practice routine or resulting in financial loss. In addition, participating practices in subsequent studies may be compensated for participation of their PIs, hygienists, dental associates and staff. Qualified dentists will be recognized by PDS authorization to exhibit the RWDCSN shield in their offices, commercial marketing and internet site. And finally, all PDS products will be provided at a preferential cost basis. 

PDS Clinical Research Faculty Membership Benefits:

1. Training and experience as principal investigator to conduct human research studies.
2. 3 Certifications from NIH in safe conduct of human research studies.
3. Training in the use and application of phytocannabinoids in dentistry. The course consists of 3 online units with Certificate of Expertise upon completion.
4. PDS recognition as Clinical Research Faculty Member upon successful completion of 1-3 above.
5. Clinical site training of dentists, hygienists and additional staff, with subsequent Study Site authorization by PDS CDO and Clinical Research Coordinator.
6. Clinical data IT training and support by PDS staff.
7. Test products and all materials (Protocols, Consent form, etc.) supplied electronically by PDS.
8. Early access to all test products.
9. Preferential pricing of PDS products.
10. Financial support for practice participation and subject recruitment in PDS clinical studies.
11. Authorization to use the PDS clinical research faculty shield for commercial and advertising purposes including website display.
12. Recognition as contributing author on PDS clinical publications.

Please sign up to learn more and apply!

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