Randomized, Double Blind, Placebo Controlled Trial of Polo Tabs Containing Igy to Reduce Oral Colonization by S Mutans in Children

Background: The present study aims to evaluate the S Mutans-inhibitory effect of oral IgY among healthy 4-12 year old Indian children and compare it with Chlorhexidine and herbal mouthwash for the same

Methods: 80 children aged between 4–12 years were randomly selected for the study after due consent and ethical clearance and divided into IgY Tab, Placebo Tab, Herbal mouthwash and Chlorhexidine mouthwash groups. Saliva samples from the same subjects were obtained at 16, 30, 45, 60 days after the start of the experiment after continuing due applications of their respective group for 15 days and then discontinuing all medications. Clinical and lab assessments are performed and colonies are counted after due lab protocols.

Results: The variables were assessed for normality using the Kolmogorov Smirnov test. ANOVA test was used for comparison of all clinical indicators and Chi-square test used for qualitative data. On day 16 evaluations it was seen that the S Mutans score reduction was seen maximum in Chlorhexidine group & IgY group. On day 30 evaluations it was revealed that only IgY Tab group has continued effect of reduction whereas values in other groups were reaching baseline limits. Thus exhibiting that in whereas maximum reduction during usage was seen in Chlorhexidine group but IgY Tab group had the best cumulative effect as it continued to provide benefits even after stopping of the drug till about 60 days when it reached similar values to baseline.

Conclusions: The study presents evidence that IgY effectively reduces S Mutans score in children not only during its usage but also after stopping the drug, thus demonstrating the efficacy and substantivity of drug over a period of time. This drug can be used in potential combination with regular measures of oral hygiene to prevent ECC.