1625. A Barrier-Forming Oral Formulation Containing Cetylpyridinium Chloride (fCPC) Reduces Oral Microbial Load in Healthy Individuals Over a Five-Day Treatment Period
Session: Poster Abstract Session: Novel Antimicrobial Agents
Saturday, October 20, 2012
Room: SDCC Poster Hall F-H
Background:

The human oral mucosa often represents the first barrier for entry of pathogenic microbes where they can cause both local and systemic infections. Ability of oral formulations to decrease the microbial burden is an important property that should reduce the prevalence of oral diseases. In this study, we evaluated the ability of cetylpyridinium chloride-based formulation (fCPC; Halo™, Oasis Consumer Healthcare, LLC) to decrease oral microbial burden in healthy individuals over a 5-day period (a typical work week).

  Methods:  

After informed consent, healthy individuals (n = 35) were enrolled and demographic data acquired. An oral examination of the mouth was undertaken (participants who had mouth lesions or those receiving antimicrobial drugs/mouthwash were excluded). Study participants were randomly grouped based on the number of daily applications (TID or QID; n = 18 or 17, respectively). Next, the buccal mucosa was swabbed.  Participants were provided with a spray bottle containing fCPC and instructed to spray the inside of their mouth (total volume of 0.75 ml/dose), then swish for 30 sec and swallow. Oral swabs [pre- (baseline) and post-application] were cultured to determine bacterial load (expressed as colony forming units, CFUs). Participants where oral microbial burden was decreased compared to baseline on day 5 were termed “responders”.

  Results:

Among individuals applying fCPC QID, the median CFUs of aerobic, anaerobic, and total bacteria decreased by 94%, 75%, and 78%, respectively compared to baseline, by day 5. The aerobic, anaerobic, and total bacterial CFUs among individuals applying fCPC TID decreased by 97%, 90%, and 97%, respectively. In both study groups, the number of responders was ≥50%. At least 60% of study participants in both groups exhibited >50% decrease in oral microbial burden of both aerobic and anaerobic bacteria. These results showed that application of fCPC led to reduction in the oral microbial burden at the end of the treatment period (See Fig).

  Conclusion:

Our studies showed that fCPC exhibits durable antimicrobial activity against oral microbes in healthy individuals, as measured by reduction in the levels of these organisms, over a 5-day treatment period (a typical work week). The developed formulation has potential to decrease infectious oral disease occurrence.

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Mahmoud Ghannoum, PhD, Case Western Reserve University/Center For Medical Mycology, Cleveland, OH, Pranab Mukherjee, PhD, Center for Medical Mycology, Department of Dermatology, University Hospitals of Cleveland, and Case Western Reverse University, Cleveland, OH, Richard Jurevic, Case Western Reserve University, Cleveland, OH, Jyostna Chandra, PhD, Dermatology (Mycology), Case Western Reserve University, Cleveland, OH, Frank Esper, MD, Rainbow Babies and Children's Hospital, Cleveland, OH, Afif Ghannoum, Oasis Consumer Helathcare, LLC, Cleveland, OH, Brian Sokol, Oasis Consumer Healthcare, LLC, Cleveland, OH and Robert Salata, MD, University Hospitals Case Medical Center, Cleveland, OH

Disclosures:

M. Ghannoum, Oasis Consumer Healthcare, LLC: Scientific Advisor, Consulting fee

P. Mukherjee, Oasis Consumer Healthcare, LLC: Research Contractor, Research support

R. Jurevic, Oasis Consumer Healthcare, LLC: Scientific Advisor, Consulting fee

J. Chandra, Oasis Consumer Healthcare, LLC: Research Contractor, Research support

F. Esper, Oasis Consumer Healthcare, LLC: Research Contractor and Scientific Advisor, Research grant

A. Ghannoum, Oasis Consumer Healthcare, LLC: Employee, Salary

B. Sokol, Oasis Consumer Healthcare, LLC: Employee, Salary

R. Salata, Oasis Consumer Healthcare, LLC: Scientific Advisor, Research support

Findings in the abstracts are embargoed until 12:01 a.m. PST, Oct. 17th with the exception of research findings presented at the IDWeek press conferences.