title: Clinical and microbiological effects of a sanguinaria-containing mouthrinse and dentifrice with and without fluoride during 6 months of use.
abstract: The purpose of this study was to test the efficacy and safety of sanguinaria-containing regimens with and without fluoride using the American Dental Association guidelines for evaluating chemotherapeutic agents. The study was a 6-month, double-blind, 4-cell, placebo-controlled, parallel investigation involving 120 subjects. Following screening procedures, subjects were randomly assigned to 4 groups. Group 1 received a dentifrice containing 0.075% sanguinaria extract (SaE) and 2.0% zinc chloride (ZnCl2) in a dicalcium phosphate base, plus an oral rinse containing 0.03% SaE and 0.2% ZnCl2. Group 2 received identical products without SaE or ZnCl2. Group 3 received a dentifrice containing 0.8% sodium monofluorophosphate, 0.075% SaE, and 0.05% ZnCl2 in a silica base, plus an oral rinse containing 0.03% SaE and 0.2% ZnCl2. Group 4 products were identical to those of Group 3 but without SaE and ZnCl2. Supragingival plaque and gingival inflammation were scored at 0, 1, 2, 1.5, 3, 4.5, and 6 months; bleeding upon probing was measured at 1, 1.5, 3, and 6 months. Microbiological samples were taken from plaque, tongue, and cheek areas. The active products produced statistically significantly lower scores than the placebo agents for all indices (P less than .0001). Six-month plaque scores were 13.1% lower for Group 1 and 17.4% lower for Group 3 compared to placebo products. When the Plaque Severity Index was applied, the percentage reductions were 33% for Group 1 and 41% for Group 3 compared to placebos. Gingival inflammation scores were 16.7% lower for Group 1 and 18.1% lower for Group 3 at 6 months compared to placebo scores.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Department of Oral Health Practice-Periodontics, University of Kentucky, College of Dentistry, Lexington.
authors.forename: R A
authors.initials: RA
authors.lastname: Kopczyk
authors.forename: H
authors.initials: H
authors.lastname: Abrams
authors.forename: A T
authors.initials: AT
authors.lastname: Brown
authors.forename: J L
authors.initials: JL
authors.lastname: Matheny
authors.forename: A L
authors.initials: AL
authors.lastname: Kaplan
mesh_terms: D000328:Adult; D000470:Alkaloids / Q000008:administration & dosage / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001419:Bacteria / Q000187:drug effects / Q000302:isolation & purification; D053119:Benzophenanthridines; D015169:Colony Count, Microbial; D003773:Dental Plaque / Q000382:microbiology / Q000517:prevention & control*; D003774:Dental Plaque Index; D003802:Dentifrices / Q000627:therapeutic use*; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D005459:Fluorides / Q000008:administration & dosage / Q000627:therapeutic use*; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D007546:Isoquinolines; D008297:Male; D009067:Mouthwashes / Q000627:therapeutic use*; D010512:Periodontal Index; D010919:Placebos
chemical_list: D000470:Alkaloids; D000900:Anti-Bacterial Agents; D053119:Benzophenanthridines; D003802:Dentifrices; D004338:Drug Combinations; D007546:Isoquinolines; D009067:Mouthwashes; D010919:Placebos; C005705:sanguinarine; D005459:Fluorides