In-vitro tests

Endurance Test

The purpose of the first research project was to measure and compare tooth resistance to a lactic acid challenge. Three groups of teeth were tested in order to compare their lactic acid endurance:

• A reference group which did not undergo treatment.

• One group that was traditionally treated by immersing the teeth in a commercial gel.

• A third group that was treated with the Fluorinex treatment.

After completing the assigned treatment for each group, the teeth were immersed in 5% lactic acid (pH=1.9) and periodically tested for deterioration of the enamel. Enamel deterioration was assessed by scraping the surface of the tooth with a sharp metal instrument and determining if the enamel was scratched by this procedure. The point at which the enamel was clearly affected was regarded as the point of failure in the lactic acid challenge.
The effectiveness of fluorine uptake is clearly translated into a much higher level of endurance in the case of the teeth treated with Fluorinex.

Endurance increased by a factor of 50  relative to non-treated teeth and by a factor of 15 relative to the best existing commercial gel treatment.

Pre-Clinical Tests

Fluorinex Active collaborated with the Hebrew University in conducting a comprehensive research project on extracted healthy human teeth. The purpose of the project was two-fold:

• Performing parametric research to define a definitive and optimal set of parameters for treatment.

• Performing a comprehensive comparison with other treatments.

The efficacy of Fluorinex treatment in preventing dental caries

Introduction
In order to speculate on the efficacy of Fluorinex treatment Fluorinex has conducted an In-vitro / ex-vivo study in order to test its treatment in regard to the fluoride uptake and release, as compared to standard APF gel treatment efficacy.

In-Vitro findings

Some findings of the In-vitro / ex-vivo study conducted by Fluorinex are presented in the table below. Comparison between Fluorinex treatment and APF gel treatment groups shows that the Fluorinex treatment incorporates more fluoride, both as an apatite and as a salt, than the standard APF gel treatment. This phenomenon is more pronounced after cycling. The ratio between Fluoride content between the 2 treatments is greater after cycling (8 vs. 6) indicating that the Fluorinex treatment is more stable to acid challenge than the standard APF gel treatment. These findings may suggest that a single treatment with Fluorinex treatment incorporates fluoride to teeth as that of at least 8 successive treatments with standard APF gel treatment. The stability of the outcome may suggest that a single treatment of Fluorinex is more efficient than 8 APF gel treatments.

Table: In vitro Fluoride profile of Fluorinex^®, APF gel and control groups with or without  cycling.  
    

The efficacy of Fluorinex^® treatment      

From the Fluorinex introduction mentioned studies it suggested, that a single Fluorinex treatment has the potential of preventing caries as that of 8 successive treatments with standard APF gel. If considered that the standard APF gel application is performed every 6 months, we can assume that the anti cariogenic effect of Fluorinex treatment may be several folds greater.

From the standpoint of cost-effectiveness, the Fluorinex treatment may be considered as a cost-effective tool as it may lower the 'number needed to treat' (NNT), indicating the number of patients that need to be treated in order to prevent 1 DMFS, usually used to estimate the efficiency of fluoride gel treatment according to the caries incidence of the target population, including cost / effect relations.

For further information read more: 

Ex-vivo poster

Ex-vivo presentation