"Per-Patient" Analysis of the 2009 Published UF Clinical Study
Authors: Zahradnik RT et al. (Oragenics, Inc.) | Published: February 19, 2013 | Type: Internal White Paper / Retrospective Analysis
Overview
The 2009 UF clinical study data was reanalyzed by an independent biostatistician on a "per-patient" basis, using each patient's four-week baseline values as the negative control compared to end-of-study bacterial counts after 4 weeks of ProBiora3® use. This analysis method copes with problems associated with large patient-to-patient variability and included all subjects that were carriers for the bacterial species of interest.
Key Findings
- 84% of population saw a decrease in the levels of S. mutans (16/19, p=0.0029) within a month of use
- 100% of population saw a decrease in the levels of Campylobacter rectus (19/19, p<0.001) within a month of use
- 71% of carriers saw a decrease in the levels of Porphyromonas gingivalis (10/14, p=0.1088) within a month of use
Results Summary
| Microbe | Decrease Response | Lower CI (%) | Upper CI (%) |
|---|---|---|---|
| A. actinomycetemcomitans | 2/2 (100%) | 15.81 | 100.00 |
| C. rectus | 19/19 (100%) | 82.35 | 100.00 |
| P. gingivalis | 10/14 (71.4%) | 41.90 | 91.61 |
| P. intermedia | 8/19 (42.1%) | 20.25 | 66.50 |
| S. mutans | 16/19 (84.2%) | 60.42 | 96.62 |
| T. forsythia | 1/1 (100%) | 2.50 | 100 |
