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Article: Phase 1 evaluation of a local delivery device releasing silver ions in periodontal pockets: Safety, pharmacokinetics and bioavailability

TitlePhase 1 evaluation of a local delivery device releasing silver ions in periodontal pockets: Safety, pharmacokinetics and bioavailability
Authors
KeywordsClinical Trial
Gingival Fluid
Local Delivery
Pharmacokinetics
Silver
Issue Date2001
PublisherWiley-Blackwell Publishing, Inc.. The Journal's web site is located at http://www.wiley.com/bw/journal.asp?ref=0022-3484&site=1
Citation
Journal Of Periodontal Research, 2001, v. 36 n. 3, p. 187-193 How to Cite?
AbstractA new local delivery device (LDD) capable of releasing silver in periodontal pockets has been developed and tested pre-clinically. Silver has potent antimicrobial effects on Gram-negative periodontal pathogens with a mean in vitro minimum bactericidal concentration (MBC) ≤0.5 μg/ml. This phase 1 study assessed the safety, pharmacokinetics and bioavailability of silver ions delivered intracrevicularly with a resorbable LDD (PocketGuard™) in a group of 9 volunteers affected with periodontitis. In each subject, a PLGA/PEG LDD loaded with 12% silver nitrate (w/w) was inserted in each of 4 selected pockets >5 mm. Serum, gingival fluid and subgingival plaque samples were evaluated before and at various time points after LDD placement for 21 days. At each time point, the concentration of silver in gingival crevicular fluid (GCF) was quantified with an Inductively Coupled Plasma-Mass Spectrometer. Subgingival plaque samples were processed for evaluation of total anaerobic and aerobic counts (CFU/ml). The maximum mean silver concentration in GCF was 1493 ± 709 μg/ml (range 589-2245). It decayed exponentially with a half-life of 7.1 ± 6.1 days (2.7-20.4). Average silver concentrations in excess of 10 μg/ml were detected in each patient for 14 days after LDD placement with the average concentration for all patients in excess of 25 μg/mL at day 21. Total anaerobic counts decreased an average of 1.7 ± 1.9 × 10 6 CFU/ml (p = 0.0078) from baseline to day 7, indicating that the silver was biologically active. A mild increase in cervical root discoloration was observed at day 21: 0.25 ± 0.31 stain index units. Discoloration that did not resolve spontaneously could be removed at the end of the study with polishing. No systemic effects were observed. It is concluded that local silver concentrations above the MBC in serum were maintained for at least 21 days. A specific microbiologic effect was also observed.
Persistent Identifierhttp://hdl.handle.net/10722/154159
ISSN
2015 Impact Factor: 2.474
2015 SCImago Journal Rankings: 0.932
References

 

DC FieldValueLanguage
dc.contributor.authorStraub, AMen_US
dc.contributor.authorSuvan, Jen_US
dc.contributor.authorLang, NPen_US
dc.contributor.authorMombelli, Aen_US
dc.contributor.authorBraman, Ven_US
dc.contributor.authorMassaro, Jen_US
dc.contributor.authorFriden, Pen_US
dc.contributor.authorTonetti, MSen_US
dc.date.accessioned2012-08-08T08:23:36Z-
dc.date.available2012-08-08T08:23:36Z-
dc.date.issued2001en_US
dc.identifier.citationJournal Of Periodontal Research, 2001, v. 36 n. 3, p. 187-193en_US
dc.identifier.issn0022-3484en_US
dc.identifier.urihttp://hdl.handle.net/10722/154159-
dc.description.abstractA new local delivery device (LDD) capable of releasing silver in periodontal pockets has been developed and tested pre-clinically. Silver has potent antimicrobial effects on Gram-negative periodontal pathogens with a mean in vitro minimum bactericidal concentration (MBC) ≤0.5 μg/ml. This phase 1 study assessed the safety, pharmacokinetics and bioavailability of silver ions delivered intracrevicularly with a resorbable LDD (PocketGuard™) in a group of 9 volunteers affected with periodontitis. In each subject, a PLGA/PEG LDD loaded with 12% silver nitrate (w/w) was inserted in each of 4 selected pockets >5 mm. Serum, gingival fluid and subgingival plaque samples were evaluated before and at various time points after LDD placement for 21 days. At each time point, the concentration of silver in gingival crevicular fluid (GCF) was quantified with an Inductively Coupled Plasma-Mass Spectrometer. Subgingival plaque samples were processed for evaluation of total anaerobic and aerobic counts (CFU/ml). The maximum mean silver concentration in GCF was 1493 ± 709 μg/ml (range 589-2245). It decayed exponentially with a half-life of 7.1 ± 6.1 days (2.7-20.4). Average silver concentrations in excess of 10 μg/ml were detected in each patient for 14 days after LDD placement with the average concentration for all patients in excess of 25 μg/mL at day 21. Total anaerobic counts decreased an average of 1.7 ± 1.9 × 10 6 CFU/ml (p = 0.0078) from baseline to day 7, indicating that the silver was biologically active. A mild increase in cervical root discoloration was observed at day 21: 0.25 ± 0.31 stain index units. Discoloration that did not resolve spontaneously could be removed at the end of the study with polishing. No systemic effects were observed. It is concluded that local silver concentrations above the MBC in serum were maintained for at least 21 days. A specific microbiologic effect was also observed.en_US
dc.languageengen_US
dc.publisherWiley-Blackwell Publishing, Inc.. The Journal's web site is located at http://www.wiley.com/bw/journal.asp?ref=0022-3484&site=1en_US
dc.relation.ispartofJournal of Periodontal Researchen_US
dc.subjectClinical Trialen_US
dc.subjectGingival Fluiden_US
dc.subjectLocal Deliveryen_US
dc.subjectPharmacokineticsen_US
dc.subjectSilveren_US
dc.titlePhase 1 evaluation of a local delivery device releasing silver ions in periodontal pockets: Safety, pharmacokinetics and bioavailabilityen_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.scopuseid_2-s2.0-0035375247en_US
dc.relation.referenceshttp://www.scopus.com/mlt/select.url?eid=2-s2.0-0035375247&selection=ref&src=s&origin=recordpageen_US
dc.identifier.volume36en_US
dc.identifier.issue3en_US
dc.identifier.spage187en_US
dc.identifier.epage193en_US
dc.publisher.placeUnited Statesen_US
dc.identifier.scopusauthoridStraub, AM=7006186066en_US
dc.identifier.scopusauthoridSuvan, J=19637686000en_US
dc.identifier.scopusauthoridLang, NP=7201577367en_US
dc.identifier.scopusauthoridMombelli, A=7006180872en_US
dc.identifier.scopusauthoridBraman, V=6602305604en_US
dc.identifier.scopusauthoridMassaro, J=7003893512en_US
dc.identifier.scopusauthoridFriden, P=55228444100en_US
dc.identifier.scopusauthoridTonetti, MS=35602248900en_US

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