Preliminary assessment of safety and effectiveness in the humans of ProBiora3, a probiotic mouthwash

Authors: R.T. Zahradnik, I. Magnusson, C. Walker, E. McDonell, C.H. Hillman, J.D. Hillman

Affiliations: Oragenics Inc., Alachua, FL; Periodontal Disease Research Center, University of Florida, Gainesville, FL; University of Illinois, Champaign, IL

Journal: Journal of Applied Microbiology | Published: 2009 | PMID: 19486429

DOI: 10.1111/j.1365-2672.2009.04243.x

Abstract

Aims: To conduct a pilot human clinical trial to assess the safety and to test the ability of a probiotic mouthwash, ProBiora3™, to affect the levels of Streptococcus mutans and certain known periodontal pathogens in the mouth when administered twice daily over a period of 4 weeks.

Methods and Results: The mouthwash contained three specific strains of naturally occurring oral bacteria — Streptococcus oralis strain KJ3sm, Streptococcus uberis strain KJ2sm, and the spontaneous lactic acid-deficient variant of Streptococcus rattus, strain JH145 — tested at two dose levels: 10⁶ and 10⁸ colony forming units. Substantial decreases in the levels of marker bacteria were observed. No safety issues were noted with twice daily application of this mouthwash.

Conclusions: Despite the small number of subjects and the use of young, orally healthy adults, along with inherent variability in microbiological measurements, the probiotic mouthwash was able to substantially affect the levels of dental pathogens in saliva and periodontal pathogens in subgingival plaque.

Study Design

19 human subjects were enrolled in this pilot study. Subjects used the ProBiora3™ probiotic mouthwash twice daily for 4 weeks. Microbiological samples were taken from saliva and subgingival plaque at baseline and at the conclusion of the study period. The study was conducted at the University of Florida Periodontal Disease Research Center.

Key Results

• Substantial decreases in S. mutans levels were observed in salivary samples
• Significant reductions in known periodontal pathogens were detected in subgingival plaque
• No adverse safety events were observed at either dose level (10⁶ or 10⁸ CFU)
• Results were consistent across both dose levels tested

Significance

This is the foundational human clinical study demonstrating the safety and effectiveness of ProBiora3® — the proprietary three-strain blend at the heart of every ProBiora Health product. The results suggest that ProBiora3® may be safe for daily use as an aid in maintaining both dental and periodontal health, providing the clinical evidence basis for its use in oral probiotic therapy.