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Objectives: This single-centre, controlled, randomized, double-blinded clinical study in parallel groups was performed to assess the efficacy of an experimental toothpaste on plaque and gingivitis., Methods: In adult subjects with gingivitis, amine fluoride/stannous chloride toothpaste (test) and monofluorophosphate toothpaste (control) were applied twice daily by regular toothbrushing at home. Evaluations of plaque index (PI), gingival index (GI), modified sulcus bleeding index (mSBI) and safety took place at baseline and after 3 and 12 weeks of study product use. After study completion, all subjects received a dental prophylaxis. A descriptive statistical analysis included means and standard deviations. Unpaired t tests compared index reductions between groups at a significance level of 0.05., Results: Intention-to-treat analysis included 240 out of 241 subjects. Baseline mean PI was reduced by 0.87 ± 0.35 in the test group and by 0.65 ± 0.41 in the control group. Within-group differences and between-group differences in index reduction were statistically significant (P < 0.001). Mean GI and mSBI were reduced significantly over time (P < 0.001) with no clinically meaningful differences between groups., Conclusions: Both toothpastes reduced plaque and gingivitis statistically significant and clinically meaningful over 12 weeks. Compared to the control toothpaste, application of the amine fluoride/stannous chloride toothpaste led to a clinically meaningful and more pronounced plaque reduction., (© 2019 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.)

A variety of parameters is available to assess the efficacy of oral antiseptics. Most study protocols select the parameters according to the specific study goal or according to preferences of the researchers. Beside general recommendations for home-use studies, no recommendations exist for other study types. Therefore, pre-selected parameters should be compared within several study designs and the most suitable parameters should be recommended for further application. The following parameters were selected before study start: plaque indices (PlI, Silness & Loe 1964, M-QHI, Turesky et al. 1970), plaque area (PlA), bacterial vitality (BV, Netuschil et al. 1989), gingivitis indices (GI, Loe 1967; M-GI, Lobene et al. 1986; BOP, Ainamo & Bay 1975), gingival crevicular fluid, colony forming units, and the discoloration index (DI, Brecx et al. 1993). The parameters were applied in four study designs: eight-hour substantivity studies, four-day plaque re-growth studies, 21-day experimental gingivitis studies, and six-month home-use studies. Pearson correlation coefficients were computed. The highest correlations were found between PlI and M-QHI and between GI and M-GI (p<0.01) in all corresponding studies and treatment groups. Few middle correlations existed between BOP and the other gingival indices. Neither GI nor M-GI correlated with GCF nor did BV with plaque indices. Inconsistent correlations were obtained between PlA and plaque indices and between PlI and GI. It is concluded, that primary parameters for these designs should be one plaque index and/or one gingivitis index to monitor plaque and gingivitis. The other parameters did not yield additional information about the study outcome.

In the literature and in the daily study routine, a wide range of study designs exists to test the efficacy of mouthrinses. Within these various designs, a considerable number of parameters is applied. Due to the different protocols currently used the outcome of these investigations is hardly to compare. Therefore, it was the aim of the present investigation to assess suitable study designs of different durations, to select and compare parameters, and to find suitable study participants in order to finally recommend more standardized protocols for future studies on oral antiseptics. Eight-hour substantivity studies, four-day plaque re-growth studies, 21-day experimental gingivitis studies, and six-month home-use studies were performed either cross-over or parallel. The clinical studies were randomized, controlled, and investigator-blinded. From most often applied clinical and laboratory parameters, two plaque indices, bacterial vitality, three gingivitis indices, gingival crevicular fluid, colony forming units, and the discoloration index were selected to assess plaque inhibition, gingivitis development, tooth staining, and possible bacterial shifts in the oral cavity. Four or five, respectively, treatment groups were formed that rinsed with the following solutions: chlorhexidine digluconate 0.06%, 0.12%, 0.20%, amine fluoride/stannous fluoride, and a negative control. In addition, all study designs were tested on two different study populations. Population alpha consisted of persons who had a gingival index <0.8 while population beta participants presented a mean gingival index of >/=0.8. Pearson correlation coefficients were calculated between parameters and between subsets of teeth and full-mouth recording. T-tests were applied to compare between populations alpha and beta.

Objective: The aim of this experimental gingivitis study was to assess the efficacy and safety of two new chlorhexidine (CHX) mouthrinses., Material and Methods: Ninety volunteers participated in this investigator-blind, randomized, clinical-controlled trial in parallel groups. During the treatment period, no oral hygiene measures except rinsing with non-alcoholic 0.2% CHX or 0.2% CHX/0.055% sodium fluoride mouthrinses, a positive control, or a negative control were permitted. The primary parameter was the gingival index; the secondary parameters were plaque index, discolouration index, and bleeding on probing. Clinical examinations were conducted 14 days before the start of the study, at baseline, and after 7, 14, and 21 days. The two sample t-test, anova, and ancova were used for the statistical analysis., Results: No difference in efficacy was found between the two new CHX formulations and the positive control. On day 21, statistically significantly less gingival inflammation and plaque accumulation compared with placebo were observed. Besides discolouration and taste irritations, no adverse events were recorded., Conclusion: The two new CHX mouthrinses were able to inhibit plaque re-growth and gingivitis. Neither the omission of alcohol nor the supplementation with sodium fluoride had weakened the clinical efficacy of CHX with respect to the analysed clinical parameters.