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Article: Experimental Gingivitis Studies: Effects of Triclosan and Triclosan-Containing Dentifrices on Dental Plaque and Gingivitis in Three-Week Randomized Controlled Clinical Trials

TitleExperimental Gingivitis Studies: Effects of Triclosan and Triclosan-Containing Dentifrices on Dental Plaque and Gingivitis in Three-Week Randomized Controlled Clinical Trials
Authors
Issue Date2002
PublisherProfessional Audience Communications, Inc. The Journal's web site is located at http://jclindent.com
Citation
Journal Of Clinical Dentistry, 2002, v. 13 n. 4, p. 158-166 How to Cite?
AbstractA recently reported six-month gingivitis study demonstrated that in subjects with gingivitis, a triclosan/pyrophosphate dentifrice provided supragingival plaque control. The level of plaque reduction was comparable with that reported for other triclosan-containing dentifrices; however, no reductions in gingivitis were observed for triclosan/pyrophosphate relative to the negative control. One possible explanation of this result is that the Hawthorne effect in the study was too great to allow the detection of a treatment benefit for the triclosan product. In order to further explore the relevance of these results, three independent clinical studies were undertaken utilizing designs based on a 21-day experimental gingivitis model in which Hawthorne effects are minimized, in part due to the absence of toothbrushing. In each model, a pre-study prophylaxis was followed by a three-week period of oral hygiene instruction to establish optimum baseline gingival health in study participants. The studies varied in enrollment; 120, 33 and 32 subjects completed treatment on studies 1, 2, and 3, respectively. In study 1, test articles were dentifrice products (0.28% triclosan/5% pyrophosphate/0.145% sodium fluoride, 0.2% triclosan/0.5% zinc citrate/0.112% sodium fluoride, 0.145% sodium fluoride and 0.15% sodium monofluorophosphate) applied neat and undiluted via a preformed tooth shield (that prevents mechanical toothbrushing at the test sites in the oral cavity) in a partial mouth design. In study 2, test articles were also dentifrice products (0.28% triclosan/5% pyrophosphate/ 0.243% sodium fluoride, 0.3% triclosan/2% GantrezĀ® copolymer/0.24% sodium fluoride and 0.243% sodium fluoride) but administered to subjects in the form of 1:3 aqueous slurry rinses. Lastly, in study 3, test articles were all mouthrinses (0.12% chlorhexidine, 0.045% triclosan in ethanol plus respective vehicle placebos). Clinical assessments to quantify the test articles' effects on the development of plaque and gingivitis were conducted at baseline (studies 1, 2 and 3), day 7 (studies 2 and 3), day 14 (studies 2 and 3) and day 21 (studies 1, 2 and 3). In study 1, no statistically significant treatment effects were observed between the test articles and controls for plaque or gingivitis development. In study 2, no statistically significant treatment effects were observed at any time point between test products for the development of gingivitis. At days 7 and 14, there were no significant differences between test products and control for plaque development as well. At day 21, the group rinsing with the triclosan/ pyrophosphate/sodium fluoride slurry had significantly less plaque accumulation than the group rinsing with the triclosan/copolymer/sodium fluoride slurry (p < 0.05); however, neither of the groups using test products containing triclosan was significantly different for plaque development from the group using the sodium fluoride control test article. In addition, aspartate aminotransferase activity in gingival crevicular fluid was assayed at days 0 and 21; no between-group differences were found at either of these time points, though day 21 AST activities were higher than those at baseline. In study 3, statistically significant treatment differences in plaque regrowth and gingivitis were observed at day 21 for the chlorhexidine rinse versus all other rinses (p < 0.05). No other statistically significant treatment effects were observed between test compounds at any other time points. The results benchmark the anti-plaque and anti-gingivitis benefit for a range of triclosanbased product forms against positive and negative controls in a three different experimental gingivitis models, a design considered predictive of clinical efficacy in longer-term investigations. It is concluded that dentifrice products containing triclosan do not possess sufficient antimicrobial activity to suppress plaque and gingivitis development in the absence of normal oral hygiene, and that relative to chlorhexidine, triclosan itself offers only modest efficacy for the prevention of plaque accumulation and therefore the delayed onset of gingivitis.
Persistent Identifierhttp://hdl.handle.net/10722/154179
ISSN
1998 Impact Factor: 0.424
2015 SCImago Journal Rankings: 0.455
References

 

DC FieldValueLanguage
dc.contributor.authorLang, NPen_US
dc.contributor.authorSander, Len_US
dc.contributor.authorBarlow, Aen_US
dc.contributor.authorBrennan, Ken_US
dc.contributor.authorWhite, DJen_US
dc.contributor.authorBacca, Len_US
dc.contributor.authorBartizek, RDen_US
dc.contributor.authorMcclanahan, SFen_US
dc.date.accessioned2012-08-08T08:23:44Z-
dc.date.available2012-08-08T08:23:44Z-
dc.date.issued2002en_US
dc.identifier.citationJournal Of Clinical Dentistry, 2002, v. 13 n. 4, p. 158-166en_US
dc.identifier.issn0895-8831en_US
dc.identifier.urihttp://hdl.handle.net/10722/154179-
dc.description.abstractA recently reported six-month gingivitis study demonstrated that in subjects with gingivitis, a triclosan/pyrophosphate dentifrice provided supragingival plaque control. The level of plaque reduction was comparable with that reported for other triclosan-containing dentifrices; however, no reductions in gingivitis were observed for triclosan/pyrophosphate relative to the negative control. One possible explanation of this result is that the Hawthorne effect in the study was too great to allow the detection of a treatment benefit for the triclosan product. In order to further explore the relevance of these results, three independent clinical studies were undertaken utilizing designs based on a 21-day experimental gingivitis model in which Hawthorne effects are minimized, in part due to the absence of toothbrushing. In each model, a pre-study prophylaxis was followed by a three-week period of oral hygiene instruction to establish optimum baseline gingival health in study participants. The studies varied in enrollment; 120, 33 and 32 subjects completed treatment on studies 1, 2, and 3, respectively. In study 1, test articles were dentifrice products (0.28% triclosan/5% pyrophosphate/0.145% sodium fluoride, 0.2% triclosan/0.5% zinc citrate/0.112% sodium fluoride, 0.145% sodium fluoride and 0.15% sodium monofluorophosphate) applied neat and undiluted via a preformed tooth shield (that prevents mechanical toothbrushing at the test sites in the oral cavity) in a partial mouth design. In study 2, test articles were also dentifrice products (0.28% triclosan/5% pyrophosphate/ 0.243% sodium fluoride, 0.3% triclosan/2% GantrezĀ® copolymer/0.24% sodium fluoride and 0.243% sodium fluoride) but administered to subjects in the form of 1:3 aqueous slurry rinses. Lastly, in study 3, test articles were all mouthrinses (0.12% chlorhexidine, 0.045% triclosan in ethanol plus respective vehicle placebos). Clinical assessments to quantify the test articles' effects on the development of plaque and gingivitis were conducted at baseline (studies 1, 2 and 3), day 7 (studies 2 and 3), day 14 (studies 2 and 3) and day 21 (studies 1, 2 and 3). In study 1, no statistically significant treatment effects were observed between the test articles and controls for plaque or gingivitis development. In study 2, no statistically significant treatment effects were observed at any time point between test products for the development of gingivitis. At days 7 and 14, there were no significant differences between test products and control for plaque development as well. At day 21, the group rinsing with the triclosan/ pyrophosphate/sodium fluoride slurry had significantly less plaque accumulation than the group rinsing with the triclosan/copolymer/sodium fluoride slurry (p < 0.05); however, neither of the groups using test products containing triclosan was significantly different for plaque development from the group using the sodium fluoride control test article. In addition, aspartate aminotransferase activity in gingival crevicular fluid was assayed at days 0 and 21; no between-group differences were found at either of these time points, though day 21 AST activities were higher than those at baseline. In study 3, statistically significant treatment differences in plaque regrowth and gingivitis were observed at day 21 for the chlorhexidine rinse versus all other rinses (p < 0.05). No other statistically significant treatment effects were observed between test compounds at any other time points. The results benchmark the anti-plaque and anti-gingivitis benefit for a range of triclosanbased product forms against positive and negative controls in a three different experimental gingivitis models, a design considered predictive of clinical efficacy in longer-term investigations. It is concluded that dentifrice products containing triclosan do not possess sufficient antimicrobial activity to suppress plaque and gingivitis development in the absence of normal oral hygiene, and that relative to chlorhexidine, triclosan itself offers only modest efficacy for the prevention of plaque accumulation and therefore the delayed onset of gingivitis.en_US
dc.languageengen_US
dc.publisherProfessional Audience Communications, Inc. The Journal's web site is located at http://jclindent.comen_US
dc.relation.ispartofJournal of Clinical Dentistryen_US
dc.subject.meshAdolescenten_US
dc.subject.meshAdulten_US
dc.subject.meshAnalysis Of Varianceen_US
dc.subject.meshAnti-Infective Agents, Local - Therapeutic Useen_US
dc.subject.meshDental Plaque - Prevention & Controlen_US
dc.subject.meshDentifrices - Chemistry - Therapeutic Useen_US
dc.subject.meshDrug Combinationsen_US
dc.subject.meshFemaleen_US
dc.subject.meshGingivitis - Prevention & Controlen_US
dc.subject.meshHumansen_US
dc.subject.meshLeast-Squares Analysisen_US
dc.subject.meshMaleen_US
dc.subject.meshMiddle Ageden_US
dc.subject.meshMouthwashes - Chemistry - Therapeutic Useen_US
dc.subject.meshStatistics, Nonparametricen_US
dc.subject.meshTreatment Failureen_US
dc.subject.meshTriclosan - Therapeutic Useen_US
dc.titleExperimental Gingivitis Studies: Effects of Triclosan and Triclosan-Containing Dentifrices on Dental Plaque and Gingivitis in Three-Week Randomized Controlled Clinical Trialsen_US
dc.typeArticleen_US
dc.identifier.emailLang, NP:nplang@hkucc.hku.hken_US
dc.identifier.authorityLang, NP=rp00031en_US
dc.description.naturelink_to_subscribed_fulltexten_US
dc.identifier.pmid12116726en_US
dc.identifier.scopuseid_2-s2.0-0036044416en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0036044416&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume13en_US
dc.identifier.issue4en_US
dc.identifier.spage158en_US
dc.identifier.epage166en_US
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridLang, NP=7201577367en_US
dc.identifier.scopusauthoridSander, L=7103372423en_US
dc.identifier.scopusauthoridBarlow, A=7102110527en_US
dc.identifier.scopusauthoridBrennan, K=7101775841en_US
dc.identifier.scopusauthoridWhite, DJ=7404818417en_US
dc.identifier.scopusauthoridBacca, L=6603217342en_US
dc.identifier.scopusauthoridBartizek, RD=7003875369en_US
dc.identifier.scopusauthoridMcClanahan, SF=7004127236en_US

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