Document Detail

2 multi-center trials assessing the clinical efficacy of 5% sanguinarine in a biodegradable drug delivery system.
MedLine Citation:
PMID:  8877666     Owner:  NLM     Status:  MEDLINE    
A biodegradable drug delivery system containing 5% sanguinarium (Sa) was compared to vehicle control (VC), scaling and root planing (SRP), and supragingival plaque control (SPC) in the treatment of adult periodontitis in 2 well-controlled clinical trials. Studies were 4-quadrant (split mouth) designs at 2 centers each, having 94 (Study A) and 107 (Study B) patients. All patients had at least 3 pockets between 5 and 9 mm that bled on probing, in each quadrant. Probing pocket depth (PD), clinical attachment level (AL), bleeding on probing (BOP), and plaque index were recorded at baseline, 14, 30, 60, and 90 days. All treatments gave statistically significant reductions from baseline for PD and BOP, and significant gains for AL. For PD reduction, SRP was superior to all test groups at all time points in both studies (p < 0.001). Sa was superior to VC in Study A at 14 and 30 days and to SPC at all time points. For AL gain at 90 days, in both studies, SRP gave gains of 0.42 and 0.78 mm respectively with superiority seen over the SPC group at 90 days (p < 0.001) in study A only, For BOP reduction, in Study A SRP was superior to Sa, VC, and SPC at 60 and 90 days (p < 0.005) and in Study B superiority to Sa and VC was at 90 days and to SPC at 60 days (p < 0.05). Sa was superior to VC for pocket depth in deep pockets only. Sa failed to demonstrate superiority over VC on a consistent basis. Analysis of residual Sa indicates that Sa potency was insufficient to show an advantage beyond clinical effects inherent in treatments with VC and SPC.
A M Polson; N H Stoller; P J Hanes; C L Bandt; S Garrett; G L Southard
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Journal of clinical periodontology     Volume:  23     ISSN:  0303-6979     ISO Abbreviation:  J. Clin. Periodontol.     Publication Date:  1996 Aug 
Date Detail:
Created Date:  1997-05-13     Completed Date:  1997-05-13     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0425123     Medline TA:  J Clin Periodontol     Country:  DENMARK    
Other Details:
Languages:  eng     Pagination:  782-8     Citation Subset:  D; IM    
Atrix Laboratories, Inc., Fort Collins, CO 80525, USA.
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MeSH Terms
Alkaloids / administration & dosage*,  therapeutic use
Analysis of Variance
Anti-Infective Agents, Local / administration & dosage*,  therapeutic use
Biodegradation, Environmental
Drug Delivery Systems*
Middle Aged
Periodontal Attachment Loss / pathology
Periodontal Index
Periodontal Pocket / drug therapy
Periodontitis / drug therapy*
Treatment Outcome
Reg. No./Substance:
0/Alkaloids; 0/Anti-Infective Agents, Local; 0/Benzophenanthridines; 0/Isoquinolines; 2447-54-3/sanguinarine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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