AbstractBackground: Herbal products, including dentifrices, appear to have become an attractive alternative for some consumers and their use has gained appreciable acceptance all over the world. This could be partly due to the perception that herbal toothpastes like other herbal products are “natural”, devoid of chemicals and therefore superior to regular toothpastes. The disturbing remarks that adverse drug reactions do occur from the use of herbal toothpaste stated the need for post marketing surveillance of two herbal dentifrices and prompted this study.
Objective: To evaluate the safety and possible adverse effects of two herbal dentifrices. Materials and Methods: 100 Dental students (45 males, 55 females) attending the first and second years (corresponding to age group 18-19 years) at Inderprastha Dental College and Hospital, Sahibabad - Ghaziabad, India; madeup the study population. Oral signs and symptoms (adverse effects) to be seen included erythema, edema,pain, irritation and burning sensation. Data analysis was done using the SPSS (version 16.0). P values d” 0.05 was considered statistically significant. Results: A total of 98 students, 44 (45%) males and 54 (55%) females,who were allotted two experimental groups (Gel and Toothpaste), completed the 2 weeks clinical trial. The age range of participants was 18-19 years. There was no statistically significant association between the use of herbal toothpastes and adverse reactions (p value > 0.0.5). Conclusion: The use of the two herbal dentifrices in this study resulted in only negligible adverse effects (1 in 98; i.e. 1.02% population) and hence may be considered safe in consumers.
Keywords: Herbal dentifrices; Adverse reactions; Safety; Erythema; Burning sensation; Pain; Irritation;
Dental students.