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. Me...
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| Published in | Caries research Vol. 39; no. 3; pp. 241 - 250 |
|---|---|
| Main Authors | , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Basel, Switzerland
S. Karger AG
01.05.2005
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| Subjects | |
| Online Access | Get full text |
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| 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 ≧ 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. Conclusion: Plantibody is safe but not effective at the frequency, concentration, and number of applications used in this study. |
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| AbstractList | 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 greater than or equal to 10 super(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. Conclusion: Plantibody is safe but not effective at the frequency, concentration, and number of applications used in this study. OBJECTIVEThis 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.METHODSFollowing 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.RESULTSAmong 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.CONCLUSIONPlantibody is safe but not effective at the frequency, concentration, and number of applications used in this study. 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 ≥ 104 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. Conclusion: Plantibody is safe but not effective at the frequency, concentration, and number of applications used in this study. Copyright © 2005 S. Karger AG, Basel 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 ≧ 104 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. Conclusion: Plantibody is safe but not effective at the frequency, concentration, and number of applications used in this study. 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 ≧ 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. Conclusion: Plantibody is safe but not effective at the frequency, concentration, and number of applications used in this study. 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. 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. 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. Plantibody is safe but not effective at the frequency, concentration, and number of applications used in this study. |
| Author | Hilton, J.F. Yu, L. Larrick, J.W. Hoover, C.I. White, J.M. Featherstone, J.D.B. Weintraub, J.A. Wycoff, K.L. |
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| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/15914988$$D View this record in MEDLINE/PubMed |
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| Cites_doi | 10.1016%2F0030-4220%2891%2990461-K 10.1016%2F0003-9969%2890%2990140-6 10.1126%2Fscience.7732380 10.3109%2F00016356408993968 10.1002%2Feji.1830240120 10.1016%2F0003-9969%2872%2990164-1 10.1016%2F0003-9969%2873%2990109-X 10.1159%2F000261451 10.3109%2F00016356309011240 10.1038%2Fnm0598-601 10.1111%2Fj.1399-302X.1989.tb00243.x |
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| Keywords | Dental caries Mutans streptococci Cariology Preventive dentistry Antimicrobial treatment Randomized clinical trial Antibody |
| Language | English |
| License | Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Copyright (c) 2005 S. Karger AG, Basel. |
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| SubjectTerms | Adult Aged Anti-Infective Agents, Local - therapeutic use Chlorhexidine - therapeutic use Dental Plaque - drug therapy Dental Plaque - metabolism Dental Plaque - microbiology Double-Blind Method Female Humans Immunoglobulin A, Secretory - metabolism Immunoglobulin A, Secretory - therapeutic use Male Middle Aged Nicotiana - immunology Original Paper Plant Extracts - metabolism Plant Extracts - therapeutic use Plantibodies - metabolism Plantibodies - therapeutic use Saliva - microbiology Statistics, Nonparametric Streptococcus mutans - drug effects |
| Title | Clinical Trial of a Plant-Derived Antibody on Recolonization of Mutans Streptococci |
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