Conventional clinical measurements failed to identify disease progression over a 6-month period. Significant improvements were observed in clinical parameters after SRP, and a trend towards progressive bone loss was halted and reversed. Regular and frequent maintenance visits are important following treatment to maintain improvements in clinical parameters. Smokers had deeper probing depths than non- and ex-smokers, but pockets were reduced significantly and comparably in all 3 smoking subgroups following efficacious treatment.
The effects of topical ketorolac tromethamine mouthrinse (0.1%) on gingival crevicular fluid (GCF) prostaglandin E2 (PGE2) concentrations were investigated in a 6-week, randomized, double-blind, placebo-controlled, parallel group, single center study of 42 patients with moderately advanced chronic adult periodontitis. Following screening, GCF was sampled from 6 sites per subject with filter paper strips and PGE2 levels measured using an enzyme immunoassay kit. Only those subjects with mouth median GCF PGE2 concentrations >30 ng/ml entered the rinsing phase. Eligible subjects were allocated placebo rinse in the first 2-week period (days 0 through 14), either ketorolac rinse (test group, n = 21) or placebo rinse (control group, n = 21) in the second 2-week period (days 14 through 28), and placebo rinse in the third 2-week period (days 28 through 42). Full mouth median GCF PGE2 concentrations were calculated for each subject at days 0, 14, 28, and 42, and group means were compared. From day 0 to day 14, no significant changes in GCF PGE2 concentrations were detected in either study group (P > 0.05). Utilizing mean GCF PGE2 concentrations at days 0 and 14 as covariates, no significant differences were observed in adjusted mean PGE2 levels at days 28 and 42 between the study groups (ANCOVA, P > 0.05). A statistically significant increase in GCF PGE2 levels was noted at days 28 and 42 in the placebo group (P < 0.01), but not in the ketorolac group (P > 0.05), when compared to baseline, however. GCF PGE2 levels were further studied in a subset of volunteers (n = 11) during a 12-hour period following first rinsing with mouthrinse (active or placebo) at day 14. GCF was sampled 0, 2, 4, 6, 8, and 12 hours post-rinsing. Mean PGE2 levels were higher in the placebo subgroup than in the ketorolac subgroup, and increased gradually over the 12-hour period in both subgroups. These data indicate that 1) 14 days of rinsing with 0.1% ketorolac mouthrinse controlled the elevation of GCF PGE2 observed in the placebo group but did not actually reduce GCF PGE2 concentrations and 2) changes in GCF PGE2 levels were not detectable in the 12-hour period following first rinsing with ketorolac.
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.
This study set out to demonstrate that it was possible to train general dental practitioners (gdps) to achieve and maintain high levels of inter-examiner consistency in the use of simple periodontal indices over a 12-month period. The gdps were trained by one trainer in the use of the plaque index (PII) and a modified version of the gingival index (mGI) which assessed gingival bleeding only. All the gdps underwent intensive training and employed a technique, when assessing inter-examiner consistency in the use of the PII, such that the 1st examiner did not disturb in situ plaque from 50% of the circumference of a tooth. The problem of variation due to repeat probing, when assessing inter-examiner consistency for mGI, was overcome by one examiner lightly probing gingival margins and both examiners scoring the results. The problems relating to the multicentre nature of the study included: distance between the centres, the need for strict adherence to the study protocol, consistency in the use of forms and instruments, in the application of periodontal indices, and of inclusion and exclusion criteria. Techniques for overcoming these problems included: the planning and application of a coherent study design, which employed simple indices, a detailed protocol, the recruitment of very well-motivated gdps of similar age and experience as examiners, the recruitment of an experienced trainer who trained the gdps thoroughly and monitored their performance throughout the study, and repeat visits to the practices involved to explain the nature of the study to all their staff members. Initially, the gdps achieved inter-examiner kappa scores of 0.78-0.85 (mean 0.81) for PII and of 0.73-0.94 (mean 0.87) for mGI when assessing 168 sites for each variable. During the following 12 months, individual kappa scores, assessed every 3 months at 42 sites, ranged from 0.51-0.90 for PII and from 0.73-1.00 for mGI. Mean kappa for PII scores achieved by the five gdps fell during the study from 0.81 to 0.76, whereas that for mGI rose from 0.87 to 0.92. It is concluded that it is possible to train gdps to achieve high levels of inter-examiner consistency in the use of PII and mGI and for these high levels to be maintained during a 12-month multicentre study.
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