THE EFFECTS OF A 0.12-PERCENT CHLOR-HEXIDINE-DIGLUCONATE-CONTAINING MOUTHRINSE VERSUS A PLACEBO ON PLAQUE AND GINGIVAL INFLAMMATION OVER A 3-MONTH PERIOD - A MULTICENTER STUDY CARRIED OUT IN GENERAL DENTAL PRACTICES

Several previous studies have evaluated the effects of 0.12% chlorhexi dine digluconate (ChD) mouthrinses on plaque and gingival inflammation . However, previously, none have been based in general dental practice s. The aim of this study was to evaluate the potential to conduct cont rolled periodontal clinical trials in co-operation with general dental practitioners (gdps). The project took place in 5 general dental prac tices 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 mo uth assessments for plaque and gingival bleeding at baseline, 6 and 12 weeks. 60 subjects were randomly asigned to use the 0.12% ChD mouthwa sh 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 (mea n 0.81) for the plaque index (P1I), and of 0.73-0.94 (mean 0.87) for a modified gingival index (mGI), and who maintained kappa scores Of 0.5 1-0.90 for P1I 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 t he study. Even though the baseline levels of plaque and gingivitis wer e low by week 12, mean whole mouth plaque score of the ChD mouthwash u sers had fallen from 1.33 at baseline to 0.96 and was significantly lo wer (p<0.001) than for the placebo users, 1.31 at baseline to 1.13. Wh ole-mouth gingival bleeding score fell from 0.56 to 0.42 in the ChD mo uthwash group but was unchanged (0.54-0.55) in the placebo group. A su bsidiary data analysis which considered the effects at sites indicated that within these overall differences, the ChD users experienced almo st 2x 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 c oncluded that 0.12% ChD mouthwash reduced plaque accumulation by 28% a nd gingival inflammation by 25% over a 12-week period, that it is feas ible for a group of gdps to maintain high levels of inter-examiner con sistency in the use of P1I 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 mouthri nses may well mask variations in response throughout the mouth.