Oral Antiseptic Testing


Oral Antiseptic Testing

CCCC

Oral antiseptics are oral rinses designed to prevent or halt the growth or action of microorganisms on living tissue, either by inhibiting the activity of the microorganisms or eliminating them entirely in the oral cavity. Rinsing with oral antiseptics is recommended prior to and during dental and oral surgery to reduce the number of potential pathogens in the treated tissue. By reducing the number of potential pathogens, the chance of bacterial infections as a result of the procedure is also reduced. In addition, the use of these products also protects the healthcare personnel performing the procedure by reducing the number of aerosolized pathogens as a result of dental equipment.

Regulation of Oral Antiseptics - Anti-Plaque and Anti-Gingivitis Proposed Rule 2003

The 2003 Proposed Rule Subcommittee is of the opinion that clinical studies should be at least 6 months long in order to provide enough time for the active ingredient to exert its intended anti-gingivitis or anti-plaque effect, as well as to allow any adverse events from regular use to be observed and reported. A minimum study length of 6 months also provides sufficient time to evaluate whether an over the counter oral ingredient, if used daily over an extended period of time, may cause a shift in the oral flora resulting in a proliferation of pathogenic oral microorganisms. Evaluations within a study are recommended to be performed at the beginning of the study, upon completion of the study, and at appropriate intervals throughout the duration of the study. 

Testing Oral Antiseptics

Vivo Clinical Testing can offer both clinical and non-clinical testing options for oral antiseptics. With a highly experienced staff in both GLP and GCP-compliant testing, the scientists at Vivo can help you with the research and development of your formulation via preliminary in vitro test methodologies, and progress all the way through in vivo clinical testing and marketing claim substantiation through consumer research evaluations, supported by Vivo's extensive human subject database. 

Oral Antiseptic Test Methodologies

•ISO 16408 - Dentistry - Oral Hygiene Products - Oral Rinses

This International Standard specifies the chemical and physical properties of oral rinses, as well as the test methods to be used for evaluations of efficacy. Common labeling aspects are also specified in order to enchance international understanding and trade.

ASTM E2315 - Assessment of Antimicrobial Activity Using a Time-Kill Procedure

This non-clinical test method can be used to evaluate your test article in vitro. Evaluations of product efficacy can be performed against microorganisms prevalent in the oral cavity, including those that have been linked with common oral diseases.

Anti-Plaque / Anti-Gingivitis Test Methodologies

•ASTM E2545 - Standard Test Method for Objective Measurement of Gingival Color Using Digital Still Cameras

Examples of Oral Antiseptic Claims

Vivo Clinical Testing can offer both clinical and non-clinical testing options for oral antiseptics. With a highly experienced staff in both GLP and GCP-compliant testing, the scientists at Vivo can help you with the research and development of your formulation via preliminary in vitro test methodologies, and progress all the way through in vivo clinical testing and marketing claim substantiation through consumer research evaluations, supported by Vivo's extensive human subject database. 

•"12 hour protection from germs that cause plaque"
•"Kills 99% of plaque and gingivitis germs"
•"Anti-cavity rinses can reduce cavities up to 70% more than brushing with fluoride toothpaste alone"
•"Leaves your breath feeling fresher!"
•"Kills 99% of bad breath germs in lab studies"

Summary of FDA Testing Guidelines for Oral Antiseptic And Anti-Gingivitis / Anti-Plaque Products

oral antiseptic regulatory guidance

HOW TO DESIGN A ROBUST STUDY FOR YOUR Oral Antiseptic PROJECT

In addition to specifying the log10 reductions for oral antiseptic formulations, FDA has also asserted experimental controls that should be incorporated into these studies. Vivo has a deep understanding of what it takes to satisfy the FDA's requirements for designing scientifically defensible studies and accounting for variability between study subjects, and incorporates the following controls or elements into our studies, as appropriate:

•Neutralization verification control
•Negative and/or vehicle control
•Positive (i.e. reference or active) control
•A sample size large enough to achieve statistically sensitive results
•Adequate randomization of test or control article distribution
•Analysis of the proportion of subjects who meet the log reduction criteria based on a two-sided statistical test and a 95% confidence interval, coupled with superiority and non-inferiority determinations

WHY VIVO CLINICAL TESTING?

Vivo Clinical Testing is a contract testing laboratory designed to support the hand hygiene and infection control industry. Vivo Clinical Testing was founded in 2017 by Dr. Benjamin Tanner, a respected microbiologist and owner of Microchem Laboratory.  The Vivo Clinical Testing laboratory offers testing in compliance with current FDA, Good Laboratory Practice (GLP), and Good Clinical Practice (GCP) regulations.  Clients are welcome to tour the lab, observe studies, and audit the lab's quality system. The lab is staffed by a capable, friendly group of scientists, mostly microbiologists.  We understand what our clients need:  Fairly priced testing services, done accurately and reported quickly.