Long-term clinical study: Caries prevention with BioHAP

Introduction

Toothpaste has many functions. It primarily contributes to the mechanical cleaning of the teeth. Additional active substances or ingredients support gum health or prevent and treat sensitive teeth, for example. In addition, toothpaste has other active ingredients to prevent caries. According to current knowledge and based on clinical studies, there are only two active ingredients that are effective against caries. Clinical data and the results of meta-analyses are available for the two substances that confirm their effectiveness in caries prophylaxis. However, thus far there have been no clinical studies of the same basic formula where only the active ingredient is different.

Question

Study of the caries-preventive effect of a fluoride-free toothpaste with BioHAP (biomimetic hydroxyapatite) compared with a fluoridated toothpaste for adults with 1,450 ppm fluoride.

Method

This clinical study was carried out at two centres (”multicentre study”). A biometrician and statistician calculated in advance how many subjects would have to take part in the study (184) to obtain statistically valid results. The subjects were randomly assigned to the respective groups (BioHAP or fluoride). During the 18-month study, there were three visits at which the teeth were examined. Caries was diagnosed visually using the DMFS index (decayed missing filled surfaces). Additionally, the results were verified with a light-based oral scanner.

Results

After 18 months, an expected increase in caries of approx. 10% was found in the total of 194 subjects. The increase in caries in the fluoride group was approx. 13% and in the BioHAP group approx. 11%.

Conclusion

The toothpaste with BioHAP is just as effective for caries prophylaxis as the adult toothpaste with 1,450 ppm fluoride. Toothpastes containing BioHAP are safe and effective and thus suitable for broad use in the prevention of caries.

 

Fig.: Increase in caries in the control group (fluoride) and test group (BioHAP).

Read more information in the study titled "Caries-preventing effect of a hydroxyapatite-toothpaste in adults: a 18-month double-blinded randomized clinical trial".

Source: Paszynska, E., Pawinska, M., Enax, J., Meyer, F., Schulze zur Wiesche, E., May, T., Amaechi, B., Limeback, H., Hernik, A., Otulakowska-Skrzynska, J., Krahel, A., Kaminska, I., Lapinska-Antonczuk, J., Stokowska, E., Gawriolek, M. Caries-preventing effect of a hydroxyapatite-toothpaste in adults: A 18 months double-blinded randomized clinical trial., Front. Public Health 11 (2023).