Preliminary assessment of safety and effectiveness in humans of ProBiora³ [trade mark sign], a probiotic mouthwash

• Published in: Journal of applied microbiology Vol. 107; no. 2; pp. 682 - 690
• Main Authors: Zahradnik, R.T, Magnusson, I, Walker, C, McDonell, E, Hillman, C.H, Hillman, J.D
• Format: Journal Article
• Language: English
• Published: Oxford, UK Oxford, UK : Blackwell Publishing Ltd 01.08.2009; Blackwell Publishing Ltd; Blackwell
• Subjects: Adult; adults; bacteria; Biological and medical sciences; clinical trials; Colony Count, Microbial; dental caries; Dental Caries - microbiology; Dental Plaque - microbiology; Fundamental and applied biological sciences. Psychology; Humans; Microbiology; mouth; Mouth - microbiology; Mouthwashes; pathogens; periodontal disease; Pilot Projects; probiotic; probiotics; Probiotics - administration & dosage; Probiotics - therapeutic use; Rattus; safety assessment; saliva; Saliva - microbiology; Streptococcal Infections - prevention & control; Streptococcus mutans; Streptococcus mutans - isolation & purification; Streptococcus viridans; Viridans streptococci; Young Adult; Human; Probiotic; dental caries; Streptococcaceae; Periodontal disease; Streptococcus; Applied microbiology; Viridans streptococci; Dental carie; Bacteria; Micrococcales; Safety
• ISSN: 1364-5072; 1365-2672; 1365-2672
• DOI: 10.1111/j.1365-2672.2009.04243.x

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. The mouthwash contained three specific strains of naturally occurring oral bacteria and was tested at two dose levels: 10⁶ and 10⁸ colony forming units each of Strep. oralis strain KJ3sm, Strep. uberis strain KJ2sm, and the spontaneous lactic acid-deficient variant of Strep. rattus, strain JH145. Substantial decreases in the levels of the marker bacteria were observed. No safety issues were noted with the twice daily application of this mouthwash. Despite the small number of subjects and the use of young, orally healthy adults, along with the inherent variability in the microbiological measurements, the probiotic mouthwash was able to substantially affect the levels of dental pathogens in saliva and periodontal pathogens in subgingival plaque. The results of this pilot human study suggest that the probiotic mouthwash product may be safe for daily use as an aid in maintaining both dental and periodontal health.