Effect of toothpaste containing amine fluoride and stannous chloride on the reduction of dental plaque and gingival inflammation. A randomized controlled 12-week home-use study.

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.