IADR Abstract Archives
Clinically Validated Non-Cidal Technologies That Inhibit Oral Surface Biofilm Formation
Objectives: To evaluate the safety and efficacy of three experimental mouth rinses with barrier forming capability compared to control mouthrinses for the reduction of plaque and gingivitis.
Methods: This was a single-center, randomized, examiner-blind, five treatments, parallel group clinical trial. Following informed consent and screening, 180 subjects received oral tissue, gingivitis (MGI), bleeding (BI), stain (Modified Lobene), and plaque (PI) examinations followed by dental prophylaxes. Subjects were randomized to one of five mouthrinse treatment groups: alcohol-free 0.075 hexyl lauroyl argininamide hydrochloride (AF 0.075 HLA), alcohol-free 0.15 HLA (AF 0.15 HLA), alcohol-free ethyl lauroyl arginate/ no essential oils (AFLAE/NEO), positive control (ALAE/EO) or a negative control (5% hydroalcohol). All subjects brushed twice daily with a marketed non-SLS toothpaste followed by 20 mL of their assigned rinse for 30 seconds. Examinations were repeated at 2 and 4 weeks. Comparisons between investigational products were based on a repeated measure mixed model, including terms for investigational product and visit, and the baseline value as a covariate.
Results: One hundred and seventy-nine subjects were included in the efficacy analysis. There were no statistically significant differences in demographic and baseline characteristics among the five groups.
At Week 4, compared with 5% hydroalcohol, superiority, as measured by the whole-mouth mean PI was demonstrated by reductions for AF 0.075 HLA (26.6%, p<0.001), AF 0.15 HLA (24.8%, p<0.001), AFLAE/NEO 25.1%, p<0.001), and ALAE/EO (27.8%, p<0.001]).
At Week 4, compared with 5% hydroalcohol, superiority, as measured by the whole-mouth mean MGI, was demonstrated by reductions for AF 0.075 HLA (15.8%, p<0.001), AF 0.15 HLA (17.3%, p<0.001), AFLAE/NEO (15.0%, p<0.001), and ALAE/EO (19.9%, p<0.001) mouth rinses.
All study products were well tolerated.
Conclusions: HLA, a newly identified compound with barrier forming qualities, has significant clinical efficacy to help prevent plaque accumulation.
Methods: This was a single-center, randomized, examiner-blind, five treatments, parallel group clinical trial. Following informed consent and screening, 180 subjects received oral tissue, gingivitis (MGI), bleeding (BI), stain (Modified Lobene), and plaque (PI) examinations followed by dental prophylaxes. Subjects were randomized to one of five mouthrinse treatment groups: alcohol-free 0.075 hexyl lauroyl argininamide hydrochloride (AF 0.075 HLA), alcohol-free 0.15 HLA (AF 0.15 HLA), alcohol-free ethyl lauroyl arginate/ no essential oils (AFLAE/NEO), positive control (ALAE/EO) or a negative control (5% hydroalcohol). All subjects brushed twice daily with a marketed non-SLS toothpaste followed by 20 mL of their assigned rinse for 30 seconds. Examinations were repeated at 2 and 4 weeks. Comparisons between investigational products were based on a repeated measure mixed model, including terms for investigational product and visit, and the baseline value as a covariate.
Results: One hundred and seventy-nine subjects were included in the efficacy analysis. There were no statistically significant differences in demographic and baseline characteristics among the five groups.
At Week 4, compared with 5% hydroalcohol, superiority, as measured by the whole-mouth mean PI was demonstrated by reductions for AF 0.075 HLA (26.6%, p<0.001), AF 0.15 HLA (24.8%, p<0.001), AFLAE/NEO 25.1%, p<0.001), and ALAE/EO (27.8%, p<0.001]).
At Week 4, compared with 5% hydroalcohol, superiority, as measured by the whole-mouth mean MGI, was demonstrated by reductions for AF 0.075 HLA (15.8%, p<0.001), AF 0.15 HLA (17.3%, p<0.001), AFLAE/NEO (15.0%, p<0.001), and ALAE/EO (19.9%, p<0.001) mouth rinses.
All study products were well tolerated.
Conclusions: HLA, a newly identified compound with barrier forming qualities, has significant clinical efficacy to help prevent plaque accumulation.