title: Preliminary assessment of safety and effectiveness in humans of ProBiora3, a probiotic mouthwash.
abstract: OBJECTIVE
  To conduct a pilot human clinical trial to assess the safety and to test the ability of a probiotic mouthwash, ProBiora(3), 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.
  
  
  RESULTS
  The mouthwash contained three specific strains of naturally occurring oral bacteria and was tested at two dose levels: 10(6) and 10(8) 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.
  
  
  CONCLUSIONS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Oragenics Inc., Alachua, FL 32615, USA.
authors.forename: R T
authors.initials: RT
authors.lastname: Zahradnik
authors.forename: I
authors.initials: I
authors.lastname: Magnusson
authors.forename: C
authors.initials: C
authors.lastname: Walker
authors.forename: E
authors.initials: E
authors.lastname: McDonell
authors.forename: C H
authors.initials: CH
authors.lastname: Hillman
authors.forename: J D
authors.initials: JD
authors.lastname: Hillman
mesh_terms: D000328:Adult; D015169:Colony Count, Microbial; D003731:Dental Caries / Q000382:microbiology; D003773:Dental Plaque / Q000382:microbiology*; D006801:Humans; D009055:Mouth / Q000382:microbiology; D009067:Mouthwashes; D010865:Pilot Projects; D019936:Probiotics / Q000008:administration & dosage / Q000627:therapeutic use*; D012463:Saliva / Q000382:microbiology*; D013290:Streptococcal Infections / Q000517:prevention & control; D013295:Streptococcus mutans / Q000302:isolation & purification*; D055815:Young Adult
chemical_list: D009067:Mouthwashes