Xerostomia, or dry mouth, affects approximately 20% of the U.S. population, some 64 million people by causing oral discomfort and pain due to chronically dry mucosa. This condition leads to oral disease such as caries and candidiasis, and has no cure or adequate treatment. Many remedial approaches have been tried with only limited success, including the provision of fluid to the mouth via frequent sipping, various mouthwashes, sprays and lozenges, electric stimulation of native salivary glands (ineffective for Sjgren?s patients), and potential cellular regeneration strategies to augment or replace salivary glands. Oral Fluid Dynamics, LLC (OFD) proposes to treat Xerostomia with a radically new approach: A dental implant to harvest and filter fluid from the jaw bone and to discharge the filtered fluid into the mouth as substitute saliva. OFD?s pilot animal studies have demonstrated that dental implants can harvest fluid within mandibular bone over a two-year period, that the fluid is abundantly available and constantly replenished, and that it could provide a continual supply of oral fluid for the relief of Xerostomia. Dental implants are currently the standard of care to replace missing teeth and have shown to be successful for patients of all ages with few limitations regarding systemic health. Many Xerostomic patients are middle and older age and are often missing teeth, affording the opportunity to address both problems with this specially designed implant. The overall goal of this project is to develop a dental implant device that serves as a salivary gland replacement that will change the standard of care for patients with Xerostomia.

Public Health Relevance

to Public Health: Dry mouth (xerostomia) due to abnormally low salivation affects 64 million people in the United States, resulting directly from immunological compromise of salivary glands (Sjgren?s Syndrome) as well as from side-effects of medications and post- radiation treatment of head/neck cancer. Dry mouth causes discomfort, pain, tooth decay, and fungal infection. Oral Fluid Dynamics, LLC is developing a standard dental implant device that moves continuously available fluid residing inside jaw bones through a membrane filter and into the mouth as a saliva substitute.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Small Business Technology Transfer (STTR) Grants - Phase I (R41)
Project #
1R41DE028217-01
Application #
9621348
Study Section
Special Emphasis Panel (ZRG1)
Program Officer
Chander, Preethi
Project Start
2018-08-07
Project End
2019-07-31
Budget Start
2018-08-07
Budget End
2019-07-31
Support Year
1
Fiscal Year
2018
Total Cost
Indirect Cost
Name
Oral Fluid Dynamics, LLC
Department
Type
DUNS #
065870515
City
Farmington
State
CT
Country
United States
Zip Code