Clinical study to evaluate the efficacy and safety of an herbal toothpaste in reducing gingivitis in a diabetic population.

Purpose: To assess the efficacy and safety of Glister multi-action toothpaste Herbals (GHT) on gingivitis in diabetic subjects.

Methods: A total of 72 diabetic subjects were enrolled and 61 subjects completed the open label single arm clinical study for a period of 30 days. Subjects were evaluated on Day 10 (visit 3), Day 20 (visit 4), and Day 30 (visit 5) for reduction in gingivitis, plaque, gingival bleeding, pocket depth, S. mutans count, hypersensitivity, teeth whiteness, extrinsic stains, malodor, product tolerance, product sensory experience and product perception.

Results: Modified Gingival Index mean (SD) score was 1.91 (0.82) at screening, reduced to 1.5 (0.9) at Day 10, 1.4 (0.8) at Day 20 and 1.2 (0.6) at Day 30, respectively. The P-value was highly significant (P< 0.0001) on Days 10, 20 and 30 when compared to screening as well as from Day 10 to Day 20, and Day 20 to Day 30.The Modified Plaque Index mean (SD) score was 1.6 (0.7) on screening day which reduced to 1.3 (0.7) on Day 10, 1.1 (0.7) on Day 20 and 1.0 (0.6) on Day 30, respectively from screening. Significant reduction (P< 0.0001) in plaque was observed in as early as 10 days of regular usage. Similarly, gingival bleeding reduced significantly (P< 0.0001) from screening day value 86.5 (16.1) to Day 10 value of 66.9 (19.8), and on Day 20 to 47.5 (15.5) and Day 30 to 33.0 (12.8), respectively. The S. mutans mean (SD) count from the screening day count of 43,259.7 (10,455.63) CFU/ml was reduced after the use of GHT on Day 10 to 38,662.3 (10,501.81), on Day 20 to 33,019.7 (9,803.31) and on Day 30 to 28,344.3 (9,404.42) CFU/ml respectively. At the screening visit, the malodor mean (SD) score was 2.2 (1.2), which was reduced to 1.8 (1.1) on visit 3, to 1.4 (1.0) on visit 4 and to 1.0 (0.8) on visit 5 respectively with statistical significance of P< 0.0001 on Day 10 compared to baseline, Day 20 compared to baseline and Day 10 and also on Day 30 as compared to other two intervals.

Clinical significance: In the current study, Glister Multi-action Toothpaste Herbals demonstrated a clinically significant improvement in diabetic subjects as measured by gingival index, bleeding index, plaque index, malodor and S. mutans count. The toothpaste was well accepted by the subjects without any adverse effects. Thus, this toothpaste may be beneficial in improving gum health among those with diabetes.