title: The effect of polyvinyl pyrrolidone on the clinical activity of 0.09% and 0.2% chlorhexidine mouthrinses.
abstract: BACKGROUND
  Previous studies have shown that polyvinyl pyrrolidone (PVP) added to a chlorhexidine rinse reduced extrinsic dental stain but at the expense of a reduction in plaque inhibitory activity. This effect appeared due to a reduction in the effective chlorhexidine dose to levels where dose response studies show plaque inhibition falls off rapidly. The aim of these 2 clinical studies was to determine if PVP could be added to chlorhexidine rinses to maintain efficacy and reduce staining.
  
  
  METHODS
  Study 1 involved 42 healthy dentate volunteers and was a blind, randomised, 7 treatment, crossover design balanced for residual effects. The rinses were: 1. 0.09% chlorhexidine to which was added, 2. 1% PVP, 3. 3% PVP, 4. 5% PVP, 5. 7% PVP, 6. Placebo, 7. Essential oil product. Rinses were used 2x on day one of each period after a prophylaxis. Subjects suspended tooth cleaning for 24 h and were then scored for plaque area. Study 2 used the experimental gingivitis model, involved 24 healthy dentate subjects and was a blind, randomised, 3 treatment, crossover design balanced for residual effects. The rinses were 1. 0.2% chlorhexidine, 2. 0.2% chlorhexidine/10% PVP, 3. Placebo. At baseline and the end of each study period subjects were rendered plaque, stain and calculus free, suspended oral hygiene and rinsed 2x per day. Plaque, gingivitis and stain were scored at baseline, 1, 2, and 3 weeks. Calculus was scored at baseline and 3 weeks.
  
  
  RESULTS
  Study 1: Buccal plaque scores were significantly lower with all rinses compared to placebo. Also all buccal plaque scores were significantly lower with chlorhexidine and chlorhexidine/PVP rinses compared to the essential oil/phenolic rinse. There were no significant differences between the chlorhexidine rinse and the chlorhexidine/PVP rinses. Analyses for buccal and lingual plaque combined produced, with one exception, the same results for rinse comparisons as for buccal plaque alone. Thus the essential oil/phenolic rinse just failed to reach significance compared to placebo. Study 2: Plaque and gingivitis scores were significantly lower with positive control and test rinses compared to placebo but with no difference between these rinses. Tooth and tongue stain was significantly higher with the positive control and test rinses compared to placebo but not significantly different between these 2 rinses. Calculus scores were not significantly different between the three study rinses.
  
  
  CONCLUSIONS
  Taken with previous data, the balance of evidence does not support PVP as an inhibitor of staining associated with chlorhexidine. These data are further evidence that chlorhexidine oral hygiene products, which, do not or claim not to cause staining, are most probably lacking efficacy.
authors.affiliation: Division of Restorative Dentistry, Dental School, Bristol, UK.
authors.forename: N
authors.initials: N
authors.lastname: Claydon
authors.forename: C M
authors.initials: CM
authors.lastname: Manning
authors.forename: A
authors.initials: A
authors.lastname: Darby-Dowman
authors.forename: D
authors.initials: D
authors.lastname: Ridge
authors.forename: S
authors.initials: S
authors.lastname: Smith
authors.forename: M
authors.initials: M
authors.lastname: Addy
mesh_terms: D000328:Adult; D000704:Analysis of Variance; D000891:Anti-Infective Agents, Local / Q000009:adverse effects / Q000627:therapeutic use*; D002710:Chlorhexidine / Q000009:adverse effects / Q000627:therapeutic use*; D016001:Confidence Intervals; D018592:Cross-Over Studies; D003728:Dental Calculus / Q000517:prevention & control; D003773:Dental Plaque / Q000517:prevention & control; D004305:Dose-Response Relationship, Drug; D004347:Drug Interactions; D005260:Female; D005500:Follow-Up Studies; D005891:Gingivitis / Q000517:prevention & control; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes / Q000009:adverse effects / Q000627:therapeutic use*; D009822:Oils, Volatile / Q000008:administration & dosage / Q000737:chemistry / Q000627:therapeutic use; D010859:Pigmentation Disorders / Q000139:chemically induced / Q000517:prevention & control; D010919:Placebos; D011205:Povidone / Q000009:adverse effects / Q000627:therapeutic use*; D016037:Single-Blind Method; D013223:Statistics as Topic; D018709:Statistics, Nonparametric; D014060:Tongue Diseases / Q000139:chemically induced / Q000517:prevention & control; D014075:Tooth Discoloration / Q000139:chemically induced / Q000517:prevention & control; D016896:Treatment Outcome
chemical_list: D000891:Anti-Infective Agents, Local; D009067:Mouthwashes; D009822:Oils, Volatile; D010919:Placebos; D011205:Povidone; D002710:Chlorhexidine