pyrophosphate and Gingival-Hemorrhage

The basic design for human clinical trials which examine prevention of gingivitis recurrence is well known. However, the anti-gingivitis efficacy of triclosan-containing dentifrices has not been routinely demonstrated using this design, regardless of formulation. In an effort to better understand the subtleties of design which show triclosan efficacy, a study was undertaken to prospectively test how subjects with a range of baseline disease levels (which encompassed the range of gingivitis severity documented in the triclosan literature) benefit from a triclosan dentifrice. This trial was a randomized, double-blind, parallel group, six-month study where subjects brushed twice daily with either triclosan/pyrophosphate, triclosan/copolymer, triclosan placebo or sodium fluoride control (NaF) dentifrice following a prophylaxis. Both gingivitis and bleeding were measured using the Löe-Silness Gingival Index (GI) and plaque was measured using the Turesky Plaque Index. Comparisons between treatments were performed using an analysis of covariance. At month 3, the triclosan/pyrophosphate group had a relative mean plaque benefit of 14.4% versus the triclosan placebo group (with an associated p-value of 0.004), and subjects using triclosan/copolymer had a mean reduction in GI bleeding sites of 16.2% relative to those brushing with the NaF control (with an associated p-value of 0.031). The overall results did not demonstrate a treatment effect for gingivitis or plaque for either triclosan-containing dentifrice at month 6. There was evidence of modest anti-gingivitis efficacy in the triclosan placebo. In an effort to better understand how baseline disease severity may have impacted the trial outcome, additional analyses were performed to investigate whether the magnitude of a triclosan effect was related to baseline gingivitis levels. An analysis of covariance model incorporating a baseline group interaction effect indicated that the magnitude of the treatment differences depended on the baseline scores The effect was most pronounced for GI bleeding sites. Further analysis showed that differences between triclosan dentifrices and the NaF control dentifrice were only present for subjects with more than 33 to 63 bleeding sites, depending on the specific comparison. These findings were illustrated through a series of subset analyses on subjects with > or = 20 (entire study population), > or = 31, > or = 40 and > or = 45 baseline GI bleeding sites. The magnitude of the tr

Topics: Adult; Analysis of Variance; Anti-Infective Agents, Local; Cariostatic Agents; Complex Mixtures; Dental Plaque; Dental Plaque Index; Dentifrices; Diphosphates; Double-Blind Method; Female; Fluorides; Gingival Hemorrhage; Gingivitis; Humans; Male; Maleates; Periodontal Index; Placebos; Polyvinyls; Prospective Studies; Research Design; Sensitivity and Specificity; Silicic Acid; Silicon Dioxide; Sodium Fluoride; Toothpastes; Treatment Outcome; Triclosan

A double blind, seven month clinical study was conducted to determine the effects of three Triclosan containing test dentifrices on supragingival plaque, gingivitis and supragingival calculus formation compared to a 0.8 per cent monofluorophosphate-silica control dentifrice. Each test dentifrice contained 0.3 per cent Triclosan; additionally one contained 0.75 per cent zinc citrate, the second contained 2 per cent Gantrez and the third contained 5 per cent pyrophosphate. Subjects were assigned to one of the three test groups or to the control group according to random allocation within nine strata. Subjects were evaluated for supragingival plaque and calculus formation and for gingivitis after one, four and seven months' use of the dentifrices. After seven months, the Triclosan/Gantrez and the Triclosan/pyrophosphate dentifrices each provided a statistically significant reduction of approximately 25 per cent in gingival bleeding compared to the control. Neither dentifrice gave statistically significant reductions in supragingival plaque or calculus formation. In contrast, the Triclosan/zinc citrate dentifrice provided statistically significant reductions of 33 per cent in supragingival plaque, 51 per cent in gingival bleeding and 67 per cent in supragingival calculus formation. The reductions in gingival bleeding and calculus formation were statistically superior to those of the Triclosan/Gantrez and the Triclosan/pyrophosphate products. The results demonstrate that use of the Triclosan/zinc citrate dentifrice over a seven month period provided statistically significant and clinically relevant reductions in supragingival plaque and calculus formation, and control of gingivitis as compared to a control dentifrice.

Topics: Adult; Citrates; Citric Acid; Dental Calculus; Dental Plaque; Dental Plaque Index; Dentifrices; Diphosphates; Double-Blind Method; Drug Combinations; Female; Fluorides; Gingival Hemorrhage; Gingivitis; Humans; Male; Maleates; Oral Hygiene; Periodontal Index; Phosphates; Polyvinyls; Silicon Dioxide; Tooth; Triclosan; Zinc