Evaluation of efficacy and safety of two herbal dentifrices in dental caries, toothache, and oral hygiene: A randomized active controlled prospective clinical study

Abstract

Objective: The use of herbal remedies has assumed a global dimension. A shift of preferences toward herbal ingredients in the oral care segment is gaining momentum. The current study is aimed at assessing the efficacy and safety of two herbal active toothpastes Dabur Red Toothpaste (DRT) and Dabur Babool Toothpaste (DBT) in dental caries, toothache, plaque, and oral hygiene in comparison to a chemical active-based marketed dental cream (MDC). Materials and Methods: The study was an open-label, randomized, controlled, parallel-group, monocentric, efficacy, and safety study. One hundred and twenty healthy male and female subjects between 12 and 65 years who satisfied inclusion and exclusion criteria were randomized equally (1:1:1) into three groups. Each subject was assigned to use one of the three randomized study products, which was to be used twice daily for 24 weeks. Efficacy was assessed on the basis of changes in parameters such as caries, plaque, gum bleeding, halitosis, dental stains, oral hygiene, toothache, and salivary pH; and the subject’s self-assessment of bad breath, toothache, plaque/ yellowish or sticky deposit on the teeth, and the mouth feel of toothpastes. Safety was assessed on the basis of monitoring of adverse events from baseline study completion. Results: Reduction in gum bleeding, halitosis (bad breath), microbial growth, and improvement in oral hygiene were seen in all the tested toothpastes. A significant reduction in tooth pain, stain intensity, and stain area was also observed. No deterioration in the condition of caries was observed in any of the groups. The products also helped maintain the salivary pH. None of the reported AE that was assessed was found to be related to the study treatments, except swelling (gums) and boils (tongue), one each in the DRT and MDC groups, which were resolved on their own without any sequelae. Conclusion: All the tested toothpastes were effective and safe in dental conditions such as dental caries, toothache, and oral hygiene and they were assessed to be well tolerated and safe.