Abstract

AN OPEN LABEL, SINGLE ARM, CLINICAL STUDY TO EVALUATE EFFICACY AND SAFETY OF MNDV TOOTHPASTE IN DENTAL CARE OF HEALTHY ADULTS

Gayatri Ganu*, Dheeraj Nagore, Ninad Naik and Ashish Nagoakar

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Abstract

Introduction: Oral disorders have remained the most prevalent disease group in India over the past three decades affecting almost 66.7 cr. (49.2% in comparison to 43.2 cr; 50.2%) people in 2019. Mouthwashes can be unpleasant and induce burning feelings in the oral cavity if they are not suited or used frequently. Mouth lozenges are ineffective in cases of malodour. MNDV toothpaste is a herbal toothpaste with natural ingredients that has the ability to treat dental plaque, gingivitis, and bad breath, among other things. It's supposed to help with general dental and oral health. Aim: The aim of the study is to clinically validate efficacy and safety of MNDV toothpaste in Dental Care of Healthy Adults. Methods: The study included four different visits to the study. Visit 1: Screening visit: The subject were selected for plaque index (between 2 and 4), gingivitis index (between 0.1 and 3.0), and halitosis with the use of Halimeter following the evaluation of trained staff. Visit 2: Registration [Visit 2 Day 1, Day 1, Basic Evaluation] (Before Brushing) Halitosis, gingival bleeding, plaque index and gingivitis (gingival index modified should be 0.1-3.0), etc. have been evaluated. The plaque Index should be 2-4. Adverse events and concurrent medications were recorded in Visit 3: Evaluation Phase [Visit 3 (Day 15 ± 2 days)] Visit 4: Evaluation/end of study [Visit 4 (Day 30 ± 2 days)] After the brushes, the study staff requested test product efficacy and tolerance questionnaires. Results & Conclusion: MNDV toothpaste dramatically improvement in gingivitis (gum inflammation), halimeter assessment, plaque reduction, and improved mouth feel compared to their previous toothpaste. The population began to improve from gingivitis (gum inflammation), plaque reduction after only 15 days of consumption and continued to improve for the next 30 days. The quality of life was improved as measured by various questionnaires. 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.

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