Method: The studies were single-centre, examiner blind, three treatment, parallel group, stratified and randomised studies. At screening, subjects brushed for one minute and expectorated into a white cup. Evidence of blood in the expectorant or observed bleeding when brushing was the initial entry criteria to the study. Subjects abstained from brushing over a 12 hour period prior to all study visits. Subjects went through standard oral soft tissue (OST) assessment, Bleeding Index (BI) assessment and then dental plaque assessment and any Adverse Events (AEs) were recorded. An appropriately trained dental professional performed a dental prophylaxis on all subjects. After using their assigned treatment twice daily at home for 6 weeks and 12 weeks, subjects returned to the study centre. They underwent a full OST examination and the recording of any Adverse Events (AEs). Subjects then underwent BI assessment followed by dental plaque assessment.
Result: Statistically significantly lower levels were observed in the number of bleeding sites and bleeding index at both week 6 and week 12 in subjects assigned the 67% sodium bicarbonate (with and without herbs) and 62% sodium bicarbonate (with and without herbs) toothpaste, vs. those assigned to the 0% sodium bicarbonate toothpaste. Differences in plaque scores were also observed.
Conclusion: For the bleeding variables the 67% and the 62% Sodium Bicarbonate toothpastes were statistically significantly different from the 0% Sodium Bicarbonate toothpaste at weeks 6 and 12.