A CLINICAL VALIDATION OF EFFICACY AND SAFETY OF TEST DENTAL CREAM (HERBS & MORE HERBAL DENTAL PASTE) IN DENTAL CARE OF HEALTHY ADULTS

Namita Pandharipande, Ashish Rajput and Dr. Omkar Kulkarni*

ABSTRACT

The primary objective of this study was to investigate efficacy of test products in reduction in gingivitis and secondary objective was oral malodour control, plaque reduction, reduction in gingival bleeding, carious teeth assessments. This was an open label, single center, single arm, 4 weeks clinical study to evaluate the efficacy and safety of Herbs & More Herbal Dental Paste in dental care of healthy adults. Study visits were consisting of a screening visit (Within -30 Days prior to Day 1) and enrollment (Day 1), evaluation (Day 15± 2days) and evaluation/end of study (Day 30± 2days). Subjects were report to the facility on Day 0 i.e. prior to enrolment Day 1. The study was conducted in multiple batches. Primary study indicates the Change in gingivitis was evaluated by dentist using modified gingival index compare to baseline readings i.e. before brushing on Visit 2 (Day 1) to after brushing on Visit 3 (Day 15) and Visit 4 (Day 30). Improvement in gum tightening was evaluated by dental examination by dentists. The results of the tests product showed statistically significant (P-value 0.0000) reduction in Plaque, T-VSC, Gingivitis, and Gingival bleeding as early as 15 days of use and continued to improve till 30 days. There were no adverse events (AEs) reported neither by the Investigator and Dentist nor self-reported by the subjects during the conduct of the study.

Keywords: Plaque, T-VSC, Gingivitis, Gingival bleeding.