Unique Anti-microbial Rinse to Reduce Oral Inflammation

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$344,781.00
Award Year:
2009
Program:
SBIR
Phase:
Phase I
Contract:
1R44HL101821-01
Award Id:
93984
Agency Tracking Number:
HL101821
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
BIOMEDICAL DEVELOPMENT CORP, 500 SANDAU, STE 200, SAN ANTONIO, TX, 78216
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
145377966
Principal Investigator:
CHARLES GAUNTT
(210) 308-0636
GAUNTT@BIODEVCORP.COM
Business Contact:
GREGG SIEGEL
() -
gsiegel@biodevcorp.com
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): Periodontal disease has been recently identified as a risk factor for increased morbidity and mortality for systemic diseases such as pancreatic cancer, cardiovascular disease (atherosclerosis, myocardial infarction, a nd stroke), and diabetes, as well as for pregnancy complications such as preterm birth. It is well established that periodontal disease results from microorganisms in dental plaque biofilm. Inflammatory reactions initiated by oral bacteria and their compon ents are implicated locally in the pathogenesis of periodontal tissue destruction, and may contribute to the development of systemic disease. While causality has yet to be confirmed, some studies have shown that oral health interventions may impact biologi cal markers of inflammation and disease. The goal of this project is to develop a prescription antimicrobial oral rinse to reduce bacterial bioburden in the oral cavity and combat oral disease and inflammation. Current oral rinse products are either fraugh t with side effects such as staining and taste alterations that limit their usage to acute settings, or are ineffective. Based on preliminary studies, the oral rinse developed herein is expected to be more effective than currently available prescription pr oducts without the side effects. The development of a highly effective oral rinse may have the potential to have a profound impact on public health and achieve significant commercial success. This study is a Fast-Track proposal that combines both Phase I a nd Phase II studies in one application. The Phase I portion has two Specific Aims: Aim 1. Compound Oral Rinse Formulations for Use in Clinical Trials Aim 2. Evaluate Dose-Response of the Oral Rinse in a Human Clinical Trial of Gingival Inflammation and Inv estigate Effects on Biological Markers Indicative of Systemic Disease. The Phase II portion has three Specific Aims: Aim 1. Compound Oral Rinse Formulations for Use in Clinical Trials Aim 2. Evaluate the Oral Rinse in a Human Clinical Trial of Gingivitis t o Satisfy FDA Requirements and Investigate Effects on Biological Markers Indicative of Systemic Disease. PUBLIC HEALTH RELEVANCE: Recent studies have linked oral bacteria to systemic diseases such as pancreatic cancer, diabetes, stroke and heart dis ease. Although it has yet to be proven that oral bacteria cause these diseases directly, there is some evidence that dental treatment may improve markers of disease. The development of a safe and effective mouthrinse that could remove harmful oral bacteria and potentially reduce the incidence of disease would have a significant impact on public health.

* information listed above is at the time of submission.

Agency Micro-sites


SBA logo

Department of Agriculture logo

Department of Commerce logo

Department of Defense logo

Department of Education logo

Department of Energy logo

Department of Health and Human Services logo

Department of Homeland Security logo

Department of Transportation logo

Enviromental Protection Agency logo

National Aeronautics and Space Administration logo

National Science Foundation logo
US Flag An Official Website of the United States Government