title: Clinical trial of a plant-derived antibody on recolonization of mutans streptococci.
abstract: OBJECTIVE
  This double-blinded, placebo-controlled clinical trial tested the safety and efficacy of a topical secretory IgA antibody manufactured in tobacco plants (plantibody) in preventing recolonization of mutans streptococci (MS) in human plaque as measured by whole stimulated saliva samples.
  
  
  METHODS
  Following a 9-day antimicrobial treatment with chlorhexidine (CHX), 56 eligible adults (enrollment salivary MS > or = 10(4) CFU/ml; no current caries) were randomized equally to a group receiving 0, 2, 4, or 6 topical applications of plantibody followed by 6, 4, 2, or 0 applications of placebo, respectively, over a 3-week period.
  
  
  RESULTS
  Among the 54 subjects who completed the trial, the CHX regimen eliminated salivary MS in 69%. After 6 months, there were no significant differences in MS levels by number of applications, relative to placebo (p > 0.43). No adverse effects were observed.
  
  
  CONCLUSIONS
  Plantibody is safe but not effective at the frequency, concentration, and number of applications used in this study.
authors.affiliation: Department of Preventive and Restorative Dental Sciences, School of Dentistry, University of California-San Francisco, 3333 California Street, San Francisco, CA 94143-1361, USA. janew@itsa.ucsf.edu
authors.forename: J A
authors.initials: JA
authors.lastname: Weintraub
authors.forename: J F
authors.initials: JF
authors.lastname: Hilton
authors.forename: J M
authors.initials: JM
authors.lastname: White
authors.forename: C I
authors.initials: CI
authors.lastname: Hoover
authors.forename: K L
authors.initials: KL
authors.lastname: Wycoff
authors.forename: L
authors.initials: L
authors.lastname: Yu
authors.forename: J W
authors.initials: JW
authors.lastname: Larrick
authors.forename: J D B
authors.initials: JD
authors.lastname: Featherstone
mesh_terms: D000328:Adult; D000368:Aged; D000891:Anti-Infective Agents, Local / Q000627:therapeutic use; D002710:Chlorhexidine / Q000627:therapeutic use; D003773:Dental Plaque / Q000188:drug therapy / Q000378:metabolism / Q000382:microbiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007071:Immunoglobulin A, Secretory / Q000378:metabolism / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000378:metabolism / Q000627:therapeutic use; D046549:Plantibodies / Q000378:metabolism / Q000627:therapeutic use*; D012463:Saliva / Q000382:microbiology; D018709:Statistics, Nonparametric; D013295:Streptococcus mutans / Q000187:drug effects*; D014026:Nicotiana / Q000276:immunology*
chemical_list: D000891:Anti-Infective Agents, Local; D007071:Immunoglobulin A, Secretory; D010936:Plant Extracts; D046549:Plantibodies; D002710:Chlorhexidine