Comprehensive Clinical and In-Vitro Testing Services

Tailored to Your Needs

At Bioscience of Bozeman, we offer GCP-compliant clinical trials and GLP In-Vitro services tailored to your needs. Our study implementation and scheduling process is customer focused to keep you up to date throughout the study process. Direct access to our study team allows better communication resulting in a more specific and focused study. We look forward to working with you, again.

Plaque Glycolysis and Regrowth Model (PGRM)

The Plaque Glycolysis and Regrowth Model (PGRM) is a predictive ex vivo system designed to evaluate the clinical effectiveness of antimicrobial agents, including anti-plaque and anti-gingivitis treatments, on dental plaque biofilms. This model allows for the topical application of treatments directly to dental plaque in vivo, with plaque samples collected from various oral quadrants before and after treatment.

Testing Process

Plaque samples are placed in a growth medium, incubated at 37°C for a specified period, and analyzed under standardized in vitro conditions using two primary endpoints:
  1. Glycolysis Inhibition
  2. Regrowth Inhibition

Applications

The PGRM is suitable for testing a variety of products, including:

  • Devices: Toothbrushes and other mechanical plaque removal methods.
  • Antimicrobial Products: Toothpastes, oral rinses, and other formulations.

This model is specifically recommended in the FDA’s 21 CFR Part 356, Part III for evaluating claims related to anti-gingivitis and anti-plaque efficacy.

Key Endpoints

Plaque Glycolysis and Regrowth Model (PGRM)

1. Glycolysis Inhibition

  • Glycolysis is a metabolic pathway where microorganisms in dental plaque convert dietary sugars into acids, reducing the pH of the growth medium.
  • Plaque samples treated with an effective antimicrobial agent demonstrate a higher pH (less acidic) post-incubation compared to untreated samples.
  • This increase in pH reflects the inhibition of glycolysis, preventing acid production by plaque microorganisms.

2. Regrowth Inhibition

  • Regrowth inhibition is assessed by measuring the turbidity of plaque suspensions using spectrophotometry.
  • Treated samples exhibit reduced turbidity (lower absorbance) compared to untreated samples, indicating bacterial regrowth suppression.
  • Absorbance values are calculated by subtracting the pre-incubation absorbance from the post-incubation absorbance for both treated and untreated samples.

Why Choose the PGRM?

The PGRM offers a robust and reliable method for evaluating the efficacy of oral care products, providing clear, measurable endpoints to support product claims.

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