Aim: The aim of this study was to formulate chewing gum using chlorhexidine and chitosan and to prove its antibacterial and antiplaque properties effectively at low doses of chlorhexidine. Materials and Methods: Chewing gums were prepared by using chlorhexidine and various proportions of gum base and chitosan. Hot melt technique was used to prepare chewing gums. The prepared gums were evaluated for physical parameters, compatibility studies, drug content, moisture content, stability studies and in vitro drug-release testing. To carry out in vivo study on humans double-blind, crossover clinical trial was conducted on 18 adult volunteers from Department of Oral Medicine and Radiology, JSS Dental College, Mysore. The test group administered chewing gums containing chlorhexidine, with and without the polymer, while the control group administered dummy chewing gums. The volunteers were visually examined for presence or absence of gingival erythema, gingival edema and gingival bleeding and the antibacterial activity was assessed by the reduction in bacterial count in the plaque samples. Result: As the proportion of gum base was increased, an increase in hardness of the chewing gum was observed. The formulation, which contains highest concentration of chitosan, showed more in vitro release compared to other formulation. Analysis of variance revealed significant differences between subjects receiving F1 and F5 for antiplaque activity. The post plaque samples results showed significant reduction in microbial count (P < 0.05). Conclusion: The in vivo studies on human volunteers were carried out for optimized formulation F5 containing chitosan and antibacterial agent which showed a better reduction in the bacterial count and gingival index. The dose of chlorhexidine can be reduced significantly when used along with chitosan. Chitosan containing chewing gum has a greater antibacterial effect compared with gums containing only chlorhexidine.
Key words: Chewing gum, chitosan, chlorhexidine, dental caries.