Plaque Glycolysis and Regrowth Model (PGRM)
The Plaque Glycolysis and Regrowth Model (PGRM) is a predictive ex vivo model, which evaluates the clinical effectiveness of antimicrobial (anti-plaque and anti-gingivitis) agents on plaque biofilms in the oral cavity. This model is designed so that treatments can be topically applied in vivo to dental plaque. Plaque samples are taken from different oral quadrants before and after treatment with an antimicrobial agent. Samples are then placed in appropriate growth medium, incubated at 37 °C for a specified time and analyzed under standardized conditions in vitro, using two simple and sensitive endpoints: glycolysis and regrowth inhibition.
Sampling can be done at time intervals to evaluate the retained activity of the antimicrobial agent being tested.
This model is used to evaluate products such as toothbrushes and other mechanical plaque removal products as well as antimicrobial products, such as toothpaste and mouthwash. The PGRM is recommended in the FDA’s 21 CFR Part 356, Part III for testing of anti-gingivitis and anti-plaque product claims
Glycolysis, a metabolic pathway involved in the extraction of energy from sugars, is widely used by microorganisms found in dental plaque. The microorganisms metabolize dietary sugars into acids, resulting in a reduction in pH (making it more acidic), which can be easily measured in a solution of growth medium. A plaque sample taken from a quadrant that has been treated with an effective antimicrobial formulation will exhibit a higher pH value (making it less acidic), as compared to the pH of post-incubation growth medium from an untreated plaque sample. This higher pH value is a result of inhibition of glycolysis.
Regrowth inhibition is evaluated by measuring the turbidity of plaque suspensions using spectrophotometry. A plaque sample taken from a quadrant that has been treated with an effective antimicrobial agent will show a reduction in absorbance (meaning it is less turbid), as compared to the absorbance of an untreated plaque sample. The reduction in absorbance is a result of inhibition of bacterial regrowth. Absorbance values used in this assessment are derived by subtracting the pre-incubated plaque-suspension absorbance from the post-incubated plaque-suspension absorbance for both treated and untreated quadrants.
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CHG112Clinical Hygiene: Antiperspirant; FDA Monograph