Clinical trial of a plant-derived antibody on recolonization of mutans streptococci.
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.
Weintraub
J A
JA
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
Hilton
J F
JF
White
J M
JM
Hoover
C I
CI
Wycoff
K L
KL
Yu
L
L
Larrick
J W
JW
Featherstone
J D B
JD
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*
D000891:Anti-Infective Agents, Local; D007071:Immunoglobulin A, Secretory; D010936:Plant Extracts; D046549:Plantibodies; D002710:Chlorhexidine