Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis
Objective: P‐113, a 12 amino acid histatin‐based peptide, was evaluated in a mouthrinse formulation for safety, prevention of the development of experimental gingivitis, and for its effects on periodontal flora. Method: 159 periodontally healthy subjects abstained from oral hygiene procedures and se...
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| Veröffentlicht in: | Journal of clinical periodontology 2001-05, Vol.28 (5), p.404-410 |
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| creator | Mickels, Nancy McManus, Colleen Massaro, Joseph Friden, Phillip Braman, Virginia D'Agostino, Ralph Oppenheim, Frank Warbington, Martha Dibart, Serge Van Dyke, Thomas |
| description | Objective: P‐113, a 12 amino acid histatin‐based peptide, was evaluated in a mouthrinse formulation for safety, prevention of the development of experimental gingivitis, and for its effects on periodontal flora.
Method: 159 periodontally healthy subjects abstained from oral hygiene procedures and self‐administered either 0.005%, 0.01%, 0.05% P‐113 or placebo mouthrinse formulations twice daily over a four week treatment period. During this time, the safety, anti‐plaque, and anti‐gingivitis effects of P‐113 were evaluated.
Results: There was a significant reduction in plaque (p=0.046) and a reduction in gingivitis (p=0.086) for subjects using 0.01% P‐113 mouthrinse. Significantly more subjects in the 0.01% and 0.05% treatment groups showed a small increase in plaque index of |
| doi_str_mv | 10.1034/j.1600-051x.2001.028005404.x |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_70841532</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>70841532</sourcerecordid><originalsourceid>FETCH-LOGICAL-c4494-51d1b7c1a32d962422969eeb10a59565cdddc048c06cc157bcf9004eca962a2a3</originalsourceid><addsrcrecordid>eNqVkV1v2yAUhtHUaUk__sLExdQ7u4cvO5Z2U2Vd2irapqlVcocwJgkZxqmxW_ffjyhZe70r9IrnvMADQl8IpAQYv9qmJANIQJAhpQAkBToBEBx4OnxA43-byxM0BgYsyYq8GKHTELYRzhljn9CIECZAAB0jN3XWW60cVr7CtdVtU9qYzLNyveps43GzwgpvbOhi9IlufKfiiF_juum7TWt9MNh6vOlr5QN-sd0Gm2FnWlubiDq8jqx9tp0N5-jjSrlgLo7rGXr8fvMwvU3mP2d30-t5ojkveCJIRcpcE8VoVWSUU1pkhTElASUKkQldVZUGPtGQaU1EXupVAcCNVpFWVLEzdHno3bXNU29CJ2sbtHFOedP0QeYw4UQwGsGvBzA-O4TWrOQuXlu1r5KA3NuWW7kXKve25d62fLMthzj--XhOX9ameh8-6o3AtwPwYp15_a9yeT_9dROjAB5rkkNN_AQzvNWo9o_McpYLufgxkws2_53N5kt5y_4CvpShpw</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>70841532</pqid></control><display><type>article</type><title>Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis</title><source>Access via Wiley Online Library</source><source>MEDLINE</source><creator>Mickels, Nancy ; McManus, Colleen ; Massaro, Joseph ; Friden, Phillip ; Braman, Virginia ; D'Agostino, Ralph ; Oppenheim, Frank ; Warbington, Martha ; Dibart, Serge ; Van Dyke, Thomas</creator><creatorcontrib>Mickels, Nancy ; McManus, Colleen ; Massaro, Joseph ; Friden, Phillip ; Braman, Virginia ; D'Agostino, Ralph ; Oppenheim, Frank ; Warbington, Martha ; Dibart, Serge ; Van Dyke, Thomas</creatorcontrib><description>Objective: P‐113, a 12 amino acid histatin‐based peptide, was evaluated in a mouthrinse formulation for safety, prevention of the development of experimental gingivitis, and for its effects on periodontal flora.
Method: 159 periodontally healthy subjects abstained from oral hygiene procedures and self‐administered either 0.005%, 0.01%, 0.05% P‐113 or placebo mouthrinse formulations twice daily over a four week treatment period. During this time, the safety, anti‐plaque, and anti‐gingivitis effects of P‐113 were evaluated.
Results: There was a significant reduction in plaque (p=0.046) and a reduction in gingivitis (p=0.086) for subjects using 0.01% P‐113 mouthrinse. Significantly more subjects in the 0.01% and 0.05% treatment groups showed a small increase in plaque index of <0.25 as compared to the placebo group (p<0.05). Similar trends were noted for changes in the % of sites with bleeding on probing in the 0.01% P‐113 group. There were no treatment‐related adverse events, and there were no adverse shifts in supragingival microflora during the study.
Conclusion: These data suggest that P‐113 mouthrinse is safe and reduces plaque, gingivitis and gingival bleeding in the human experimental gingivitis model.
Zusammenfassung
Ziel: P‐113, ein 12‐Aminosäure‐Histatin‐basierendes Peptid, wurde in der Darreichung als Mundspüllösung bezüglich Sicherheit, Prävention der Entwicklung einer experimentellen Gingivitis und hinsichtlich seiner Wirkung auf die parodontale Flora evaluiert.
Methode: 159 parodontal gesunde Personen enthielten sich der Mundhygiene und verwendeten selbständig für eine Dauer von 4 Wochen 2× pro Tag entweder eine 0.005%ige, 0.01%ige, 0.05%ige P‐113 oder eine Placebo‐Mundspüllösung. Während dieser Zeit wurde die Sicherheit, die Antiplaquewirkung und der Antigingivitiseffekt von P‐113 evaluiert
Ergebnisse: Bei Personen, die die 0.01%ige‐P‐113‐Mundspüllösung verwendeten gab es eine signifikante Reduktion der Plaque (p=0.046) und eine Reduktion der Gingivitis (p=0.086). Im Vergleich mit der Placebogruppe zeigten signifikant mehr Personen (p<0.05) der 0.01%‐ und 0.05%‐Behandlungsgruppen eine geringe Erhöhung des Plaque‐Index von <0.25. In der 0.01%‐P‐113‐Gruppe wurden ähnliche Trends für die Veränderung des Prozentsatzes von Stellen mit Sondierungsblutung festgestellt. Es gab keine Behandlungs‐bedingten Nebenwirkungen und es gab keine unerwünschten Verschiebungen der supragingivalen Mikroflora während der Studie.
Schlussfolgerung: Diese Daten lassen annehmen, dass die P‐113‐Mundspüllösung sicher ist und in einem Modell mit experimenteller Gingivitis am Menschen sowohl Plaque und Gingivitis als auch die Gingivablutung reduziert.
Résumé
But: P113, un peptide à base d’histatine de 12 acides aminés, a étéévalué dans une formule de bain de bouche pour sa sécurité, pour la prévention du développement de gingivite expérimentale et pour son action sur la flore parodontale.
Méthodes: 159 sujets sans maladies parodontales s’abstinrent de pratiquer une hygiène buccodentaire et prirent soit, 0.005%, 0.01%, 0.05% P‐113 ou une formule placebo 2×par jour pendant 4 semaines. Pendant ce temps, la sécurité, l’action anti‐gingivite et antiplaque furent évaluées.
Resultats: Il y avait une réduction significative de la plaque (p=0.046) et une réduction de la gingivite (p=f0.086) pour les sujets utilisant un bain de bouche à une concentration de 0.01% P‐113. Significativement plus de sujets dans les groupes de traitement 0.01% et 0.05% présentaient une petite augmentation de l’indice de plaque inférieure à 0.25 par rapport au groupe placebo. Des tendances similaires étaient notées pour les modifications du % de sites saignant au sondage dans le groupe 0.01% P‐113. Il n’y avait pas d’effets secondaires relatifs au traitement et aucune modification négative de la microflore supragingivale pendant l’étude.
Conclusions: Ces données suggèrent que le bain de bouche P‐113 est sans danger, et réduit la plaque, la gingivite et le saignement gingival dans un modèle de gingivite expérimentale chez l’homme.</description><identifier>ISSN: 0303-6979</identifier><identifier>EISSN: 1600-051X</identifier><identifier>DOI: 10.1034/j.1600-051x.2001.028005404.x</identifier><identifier>PMID: 11350502</identifier><language>eng</language><publisher>Copenhagen: Munksgaard International Publishers</publisher><subject><![CDATA[Adult ; antimicrobial mouthrinse ; Bacteria - classification ; Bacteria - drug effects ; clinical trial ; Dental Plaque - microbiology ; Dental Plaque - prevention & control ; Dental Plaque Index ; Dentistry ; Disease Progression ; Double-Blind Method ; Female ; Gingival Hemorrhage - prevention & control ; gingivitis ; Gingivitis - prevention & control ; Glycoproteins - administration & dosage ; Glycoproteins - therapeutic use ; histatin ; Histidine - administration & dosage ; Histidine - therapeutic use ; Humans ; Male ; Middle Aged ; Mouthwashes - therapeutic use ; Periodontal Index ; Periodontium - microbiology ; Placebos ; Prevotella intermedia - drug effects ; Proteins - administration & dosage ; Proteins - therapeutic use ; Safety ; Statistics as Topic ; supragingival plaque]]></subject><ispartof>Journal of clinical periodontology, 2001-05, Vol.28 (5), p.404-410</ispartof><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4494-51d1b7c1a32d962422969eeb10a59565cdddc048c06cc157bcf9004eca962a2a3</citedby><cites>FETCH-LOGICAL-c4494-51d1b7c1a32d962422969eeb10a59565cdddc048c06cc157bcf9004eca962a2a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>315,782,786,1419,27933,27934</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/11350502$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mickels, Nancy</creatorcontrib><creatorcontrib>McManus, Colleen</creatorcontrib><creatorcontrib>Massaro, Joseph</creatorcontrib><creatorcontrib>Friden, Phillip</creatorcontrib><creatorcontrib>Braman, Virginia</creatorcontrib><creatorcontrib>D'Agostino, Ralph</creatorcontrib><creatorcontrib>Oppenheim, Frank</creatorcontrib><creatorcontrib>Warbington, Martha</creatorcontrib><creatorcontrib>Dibart, Serge</creatorcontrib><creatorcontrib>Van Dyke, Thomas</creatorcontrib><title>Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis</title><title>Journal of clinical periodontology</title><addtitle>J Clin Periodontol</addtitle><description>Objective: P‐113, a 12 amino acid histatin‐based peptide, was evaluated in a mouthrinse formulation for safety, prevention of the development of experimental gingivitis, and for its effects on periodontal flora.
Method: 159 periodontally healthy subjects abstained from oral hygiene procedures and self‐administered either 0.005%, 0.01%, 0.05% P‐113 or placebo mouthrinse formulations twice daily over a four week treatment period. During this time, the safety, anti‐plaque, and anti‐gingivitis effects of P‐113 were evaluated.
Results: There was a significant reduction in plaque (p=0.046) and a reduction in gingivitis (p=0.086) for subjects using 0.01% P‐113 mouthrinse. Significantly more subjects in the 0.01% and 0.05% treatment groups showed a small increase in plaque index of <0.25 as compared to the placebo group (p<0.05). Similar trends were noted for changes in the % of sites with bleeding on probing in the 0.01% P‐113 group. There were no treatment‐related adverse events, and there were no adverse shifts in supragingival microflora during the study.
Conclusion: These data suggest that P‐113 mouthrinse is safe and reduces plaque, gingivitis and gingival bleeding in the human experimental gingivitis model.
Zusammenfassung
Ziel: P‐113, ein 12‐Aminosäure‐Histatin‐basierendes Peptid, wurde in der Darreichung als Mundspüllösung bezüglich Sicherheit, Prävention der Entwicklung einer experimentellen Gingivitis und hinsichtlich seiner Wirkung auf die parodontale Flora evaluiert.
Methode: 159 parodontal gesunde Personen enthielten sich der Mundhygiene und verwendeten selbständig für eine Dauer von 4 Wochen 2× pro Tag entweder eine 0.005%ige, 0.01%ige, 0.05%ige P‐113 oder eine Placebo‐Mundspüllösung. Während dieser Zeit wurde die Sicherheit, die Antiplaquewirkung und der Antigingivitiseffekt von P‐113 evaluiert
Ergebnisse: Bei Personen, die die 0.01%ige‐P‐113‐Mundspüllösung verwendeten gab es eine signifikante Reduktion der Plaque (p=0.046) und eine Reduktion der Gingivitis (p=0.086). Im Vergleich mit der Placebogruppe zeigten signifikant mehr Personen (p<0.05) der 0.01%‐ und 0.05%‐Behandlungsgruppen eine geringe Erhöhung des Plaque‐Index von <0.25. In der 0.01%‐P‐113‐Gruppe wurden ähnliche Trends für die Veränderung des Prozentsatzes von Stellen mit Sondierungsblutung festgestellt. Es gab keine Behandlungs‐bedingten Nebenwirkungen und es gab keine unerwünschten Verschiebungen der supragingivalen Mikroflora während der Studie.
Schlussfolgerung: Diese Daten lassen annehmen, dass die P‐113‐Mundspüllösung sicher ist und in einem Modell mit experimenteller Gingivitis am Menschen sowohl Plaque und Gingivitis als auch die Gingivablutung reduziert.
Résumé
But: P113, un peptide à base d’histatine de 12 acides aminés, a étéévalué dans une formule de bain de bouche pour sa sécurité, pour la prévention du développement de gingivite expérimentale et pour son action sur la flore parodontale.
Méthodes: 159 sujets sans maladies parodontales s’abstinrent de pratiquer une hygiène buccodentaire et prirent soit, 0.005%, 0.01%, 0.05% P‐113 ou une formule placebo 2×par jour pendant 4 semaines. Pendant ce temps, la sécurité, l’action anti‐gingivite et antiplaque furent évaluées.
Resultats: Il y avait une réduction significative de la plaque (p=0.046) et une réduction de la gingivite (p=f0.086) pour les sujets utilisant un bain de bouche à une concentration de 0.01% P‐113. Significativement plus de sujets dans les groupes de traitement 0.01% et 0.05% présentaient une petite augmentation de l’indice de plaque inférieure à 0.25 par rapport au groupe placebo. Des tendances similaires étaient notées pour les modifications du % de sites saignant au sondage dans le groupe 0.01% P‐113. Il n’y avait pas d’effets secondaires relatifs au traitement et aucune modification négative de la microflore supragingivale pendant l’étude.
Conclusions: Ces données suggèrent que le bain de bouche P‐113 est sans danger, et réduit la plaque, la gingivite et le saignement gingival dans un modèle de gingivite expérimentale chez l’homme.</description><subject>Adult</subject><subject>antimicrobial mouthrinse</subject><subject>Bacteria - classification</subject><subject>Bacteria - drug effects</subject><subject>clinical trial</subject><subject>Dental Plaque - microbiology</subject><subject>Dental Plaque - prevention & control</subject><subject>Dental Plaque Index</subject><subject>Dentistry</subject><subject>Disease Progression</subject><subject>Double-Blind Method</subject><subject>Female</subject><subject>Gingival Hemorrhage - prevention & control</subject><subject>gingivitis</subject><subject>Gingivitis - prevention & control</subject><subject>Glycoproteins - administration & dosage</subject><subject>Glycoproteins - therapeutic use</subject><subject>histatin</subject><subject>Histidine - administration & dosage</subject><subject>Histidine - therapeutic use</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Mouthwashes - therapeutic use</subject><subject>Periodontal Index</subject><subject>Periodontium - microbiology</subject><subject>Placebos</subject><subject>Prevotella intermedia - drug effects</subject><subject>Proteins - administration & dosage</subject><subject>Proteins - therapeutic use</subject><subject>Safety</subject><subject>Statistics as Topic</subject><subject>supragingival plaque</subject><issn>0303-6979</issn><issn>1600-051X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2001</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqVkV1v2yAUhtHUaUk__sLExdQ7u4cvO5Z2U2Vd2irapqlVcocwJgkZxqmxW_ffjyhZe70r9IrnvMADQl8IpAQYv9qmJANIQJAhpQAkBToBEBx4OnxA43-byxM0BgYsyYq8GKHTELYRzhljn9CIECZAAB0jN3XWW60cVr7CtdVtU9qYzLNyveps43GzwgpvbOhi9IlufKfiiF_juum7TWt9MNh6vOlr5QN-sd0Gm2FnWlubiDq8jqx9tp0N5-jjSrlgLo7rGXr8fvMwvU3mP2d30-t5ojkveCJIRcpcE8VoVWSUU1pkhTElASUKkQldVZUGPtGQaU1EXupVAcCNVpFWVLEzdHno3bXNU29CJ2sbtHFOedP0QeYw4UQwGsGvBzA-O4TWrOQuXlu1r5KA3NuWW7kXKve25d62fLMthzj--XhOX9ameh8-6o3AtwPwYp15_a9yeT_9dROjAB5rkkNN_AQzvNWo9o_McpYLufgxkws2_53N5kt5y_4CvpShpw</recordid><startdate>200105</startdate><enddate>200105</enddate><creator>Mickels, Nancy</creator><creator>McManus, Colleen</creator><creator>Massaro, Joseph</creator><creator>Friden, Phillip</creator><creator>Braman, Virginia</creator><creator>D'Agostino, Ralph</creator><creator>Oppenheim, Frank</creator><creator>Warbington, Martha</creator><creator>Dibart, Serge</creator><creator>Van Dyke, Thomas</creator><general>Munksgaard International Publishers</general><scope>BSCLL</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>200105</creationdate><title>Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis</title><author>Mickels, Nancy ; McManus, Colleen ; Massaro, Joseph ; Friden, Phillip ; Braman, Virginia ; D'Agostino, Ralph ; Oppenheim, Frank ; Warbington, Martha ; Dibart, Serge ; Van Dyke, Thomas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4494-51d1b7c1a32d962422969eeb10a59565cdddc048c06cc157bcf9004eca962a2a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2001</creationdate><topic>Adult</topic><topic>antimicrobial mouthrinse</topic><topic>Bacteria - classification</topic><topic>Bacteria - drug effects</topic><topic>clinical trial</topic><topic>Dental Plaque - microbiology</topic><topic>Dental Plaque - prevention & control</topic><topic>Dental Plaque Index</topic><topic>Dentistry</topic><topic>Disease Progression</topic><topic>Double-Blind Method</topic><topic>Female</topic><topic>Gingival Hemorrhage - prevention & control</topic><topic>gingivitis</topic><topic>Gingivitis - prevention & control</topic><topic>Glycoproteins - administration & dosage</topic><topic>Glycoproteins - therapeutic use</topic><topic>histatin</topic><topic>Histidine - administration & dosage</topic><topic>Histidine - therapeutic use</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Mouthwashes - therapeutic use</topic><topic>Periodontal Index</topic><topic>Periodontium - microbiology</topic><topic>Placebos</topic><topic>Prevotella intermedia - drug effects</topic><topic>Proteins - administration & dosage</topic><topic>Proteins - therapeutic use</topic><topic>Safety</topic><topic>Statistics as Topic</topic><topic>supragingival plaque</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mickels, Nancy</creatorcontrib><creatorcontrib>McManus, Colleen</creatorcontrib><creatorcontrib>Massaro, Joseph</creatorcontrib><creatorcontrib>Friden, Phillip</creatorcontrib><creatorcontrib>Braman, Virginia</creatorcontrib><creatorcontrib>D'Agostino, Ralph</creatorcontrib><creatorcontrib>Oppenheim, Frank</creatorcontrib><creatorcontrib>Warbington, Martha</creatorcontrib><creatorcontrib>Dibart, Serge</creatorcontrib><creatorcontrib>Van Dyke, Thomas</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical periodontology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Mickels, Nancy</au><au>McManus, Colleen</au><au>Massaro, Joseph</au><au>Friden, Phillip</au><au>Braman, Virginia</au><au>D'Agostino, Ralph</au><au>Oppenheim, Frank</au><au>Warbington, Martha</au><au>Dibart, Serge</au><au>Van Dyke, Thomas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis</atitle><jtitle>Journal of clinical periodontology</jtitle><addtitle>J Clin Periodontol</addtitle><date>2001-05</date><risdate>2001</risdate><volume>28</volume><issue>5</issue><spage>404</spage><epage>410</epage><pages>404-410</pages><issn>0303-6979</issn><eissn>1600-051X</eissn><abstract>Objective: P‐113, a 12 amino acid histatin‐based peptide, was evaluated in a mouthrinse formulation for safety, prevention of the development of experimental gingivitis, and for its effects on periodontal flora.
Method: 159 periodontally healthy subjects abstained from oral hygiene procedures and self‐administered either 0.005%, 0.01%, 0.05% P‐113 or placebo mouthrinse formulations twice daily over a four week treatment period. During this time, the safety, anti‐plaque, and anti‐gingivitis effects of P‐113 were evaluated.
Results: There was a significant reduction in plaque (p=0.046) and a reduction in gingivitis (p=0.086) for subjects using 0.01% P‐113 mouthrinse. Significantly more subjects in the 0.01% and 0.05% treatment groups showed a small increase in plaque index of <0.25 as compared to the placebo group (p<0.05). Similar trends were noted for changes in the % of sites with bleeding on probing in the 0.01% P‐113 group. There were no treatment‐related adverse events, and there were no adverse shifts in supragingival microflora during the study.
Conclusion: These data suggest that P‐113 mouthrinse is safe and reduces plaque, gingivitis and gingival bleeding in the human experimental gingivitis model.
Zusammenfassung
Ziel: P‐113, ein 12‐Aminosäure‐Histatin‐basierendes Peptid, wurde in der Darreichung als Mundspüllösung bezüglich Sicherheit, Prävention der Entwicklung einer experimentellen Gingivitis und hinsichtlich seiner Wirkung auf die parodontale Flora evaluiert.
Methode: 159 parodontal gesunde Personen enthielten sich der Mundhygiene und verwendeten selbständig für eine Dauer von 4 Wochen 2× pro Tag entweder eine 0.005%ige, 0.01%ige, 0.05%ige P‐113 oder eine Placebo‐Mundspüllösung. Während dieser Zeit wurde die Sicherheit, die Antiplaquewirkung und der Antigingivitiseffekt von P‐113 evaluiert
Ergebnisse: Bei Personen, die die 0.01%ige‐P‐113‐Mundspüllösung verwendeten gab es eine signifikante Reduktion der Plaque (p=0.046) und eine Reduktion der Gingivitis (p=0.086). Im Vergleich mit der Placebogruppe zeigten signifikant mehr Personen (p<0.05) der 0.01%‐ und 0.05%‐Behandlungsgruppen eine geringe Erhöhung des Plaque‐Index von <0.25. In der 0.01%‐P‐113‐Gruppe wurden ähnliche Trends für die Veränderung des Prozentsatzes von Stellen mit Sondierungsblutung festgestellt. Es gab keine Behandlungs‐bedingten Nebenwirkungen und es gab keine unerwünschten Verschiebungen der supragingivalen Mikroflora während der Studie.
Schlussfolgerung: Diese Daten lassen annehmen, dass die P‐113‐Mundspüllösung sicher ist und in einem Modell mit experimenteller Gingivitis am Menschen sowohl Plaque und Gingivitis als auch die Gingivablutung reduziert.
Résumé
But: P113, un peptide à base d’histatine de 12 acides aminés, a étéévalué dans une formule de bain de bouche pour sa sécurité, pour la prévention du développement de gingivite expérimentale et pour son action sur la flore parodontale.
Méthodes: 159 sujets sans maladies parodontales s’abstinrent de pratiquer une hygiène buccodentaire et prirent soit, 0.005%, 0.01%, 0.05% P‐113 ou une formule placebo 2×par jour pendant 4 semaines. Pendant ce temps, la sécurité, l’action anti‐gingivite et antiplaque furent évaluées.
Resultats: Il y avait une réduction significative de la plaque (p=0.046) et une réduction de la gingivite (p=f0.086) pour les sujets utilisant un bain de bouche à une concentration de 0.01% P‐113. Significativement plus de sujets dans les groupes de traitement 0.01% et 0.05% présentaient une petite augmentation de l’indice de plaque inférieure à 0.25 par rapport au groupe placebo. Des tendances similaires étaient notées pour les modifications du % de sites saignant au sondage dans le groupe 0.01% P‐113. Il n’y avait pas d’effets secondaires relatifs au traitement et aucune modification négative de la microflore supragingivale pendant l’étude.
Conclusions: Ces données suggèrent que le bain de bouche P‐113 est sans danger, et réduit la plaque, la gingivite et le saignement gingival dans un modèle de gingivite expérimentale chez l’homme.</abstract><cop>Copenhagen</cop><pub>Munksgaard International Publishers</pub><pmid>11350502</pmid><doi>10.1034/j.1600-051x.2001.028005404.x</doi><tpages>7</tpages></addata></record> |
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| identifier | ISSN: 0303-6979 |
| ispartof | Journal of clinical periodontology, 2001-05, Vol.28 (5), p.404-410 |
| issn | 0303-6979 1600-051X |
| language | eng |
| recordid | cdi_proquest_miscellaneous_70841532 |
| source | Access via Wiley Online Library; MEDLINE |
| subjects | Adult antimicrobial mouthrinse Bacteria - classification Bacteria - drug effects clinical trial Dental Plaque - microbiology Dental Plaque - prevention & control Dental Plaque Index Dentistry Disease Progression Double-Blind Method Female Gingival Hemorrhage - prevention & control gingivitis Gingivitis - prevention & control Glycoproteins - administration & dosage Glycoproteins - therapeutic use histatin Histidine - administration & dosage Histidine - therapeutic use Humans Male Middle Aged Mouthwashes - therapeutic use Periodontal Index Periodontium - microbiology Placebos Prevotella intermedia - drug effects Proteins - administration & dosage Proteins - therapeutic use Safety Statistics as Topic supragingival plaque |
| title | Clinical and microbial evaluation of a histatin-containing mouthrinse in humans with experimental gingivitis |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-11-30T12%3A52%3A33IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Clinical%20and%20microbial%20evaluation%20of%20a%20histatin-containing%20mouthrinse%20in%20humans%20with%20experimental%20gingivitis&rft.jtitle=Journal%20of%20clinical%20periodontology&rft.au=Mickels,%20Nancy&rft.date=2001-05&rft.volume=28&rft.issue=5&rft.spage=404&rft.epage=410&rft.pages=404-410&rft.issn=0303-6979&rft.eissn=1600-051X&rft_id=info:doi/10.1034/j.1600-051x.2001.028005404.x&rft_dat=%3Cproquest_cross%3E70841532%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=70841532&rft_id=info:pmid/11350502&rfr_iscdi=true |