title: The effects of a 0.12% chlorhexidine-digluconate-containing mouthrinse versus a placebo on plaque and gingival inflammation over a 3-month period. A multicentre study carried out in general dental practices.
abstract: Several previous studies have evaluated the effects of 0.12% chlorhexidine digluconate (ChD) mouthrinses on plaque and gingival inflammation. However, previously, none have been based in general dental practices. The aim of this study was to evaluate the potential to conduct controlled periodontal clinical trials in co-operation with general dental practitioners (gdps). The project took place in 5 general dental practices in the South of England. 121 healthy subjects (24 at 4 sites and 25 at the 5th), aged 18-65 years, mean 35 +/- 12) years participated in a double-blind, randomised study during which they received full mouth assessments for plaque and gingival bleeding at baseline, 6 and 12 weeks. 60 subjects were randomly assigned to use the 0.12% ChD mouthwash and 61 the placebo. The assessments were carried out by 5 gpds, who had previously achieved inter-examiner kappa scores of 0.78-0.85 (mean 0.81) for the plaque index (PII), and of 0.73-0.94 (mean 0.87) for a modified gingival index (mGI), and who maintained kappa scores of 0.51-0.90 for PII and of 0.73-1.00 for mGI during the 12 months required to complete the study. 98 subjects (48 ChD and 50 placebo) completed the study. Even though the baseline levels of plaque and gingivitis were low, by week 12, mean whole mouth plaque score of the ChD mouthwash users had fallen from 1.33 at baseline to 0.96 and was significantly lower (p < 0.001) than for the placebo users, 1.31 at baseline to 1.13. Whole-mouth gingival bleeding score fell from 0.56 to 0.42 in the ChD mouthwash group but was unchanged (0.54-0.55) in the placebo group. A subsidiary data analysis which considered the effects at sites indicated that within these overall differences, the ChD users experienced almost 2 x the reduction from plaque score 2 at baseline at proximal molar sites over a 12-week period (50.6% ChD versus 27.6% placebo). It was concluded that 0.12% ChD mouthwash reduced plaque accumulation by 28% and gingival inflammation by 25% over a 12-week period, that it is feasible for a group of gdps to maintain high levels of inter-examiner consistency in the use of PII and mGI, that it is also feasible to carry out such a multicentre study in general dental practice, and that the use of mean mouth scores per subject to analyse the effects of mouthrinses may well mask variations in response throughout the mouth.
authors.affiliation: Department of Periodontology. Eastman Dental Institute, London, UK.
authors.forename: K A
authors.initials: KA
authors.lastname: Eaton
authors.forename: F M
authors.initials: FM
authors.lastname: Rimini
authors.forename: E
authors.initials: E
authors.lastname: Zak
authors.forename: D J
authors.initials: DJ
authors.lastname: Brookman
authors.forename: L M
authors.initials: LM
authors.lastname: Hopkins
authors.forename: P J
authors.initials: PJ
authors.lastname: Cannell
authors.forename: L G
authors.initials: LG
authors.lastname: Yates
authors.forename: C A
authors.initials: CA
authors.lastname: Morrice
authors.forename: B A
authors.initials: BA
authors.lastname: Lall
authors.forename: H N
authors.initials: HN
authors.lastname: Newman
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000891:Anti-Infective Agents, Local / Q000008:administration & dosage / Q000627:therapeutic use*; D002710:Chlorhexidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003773:Dental Plaque / Q000517:prevention & control*; D003774:Dental Plaque Index; D004311:Double-Blind Method; D004739:England; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D005792:General Practice, Dental; D005884:Gingival Hemorrhage / Q000517:prevention & control; D005891:Gingivitis / Q000517:prevention & control*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009067:Mouthwashes; D015588:Observer Variation; D010512:Periodontal Index; D010919:Placebos
chemical_list: D000891:Anti-Infective Agents, Local; D009067:Mouthwashes; D010919:Placebos; C010882:chlorhexidine gluconate; D002710:Chlorhexidine