A study on the design, formulation and effectiveness of chewing gums containing Chlorhexidine Gluconate in the prevention of dental plaque

Statement of Problem: The role of the microbial plaque in caries etiology and periodontal diseases has been proved and the mechanical methods for plaque control have special limitations, consequently, chemical methods have been suggested. One of the most effective materials is Chlorhexidine Gluconate that is commonly used as mouth rinses. However, the medicated formulations of chewing gums, due to several properties, have been paid attention. It should be noted that a new formulation to satisfy the consumer's taste seems necessary. The aim of this study was to present a new formulation for chewing gums containing chlorhexidine to achieve a pleasant taste coupled with their effectiveness and anti-plaque properties maintenance. In this double blind, crossover, prospective clinical trial, 18 volunteers were investigated. Chlorhexidine Gluconate was used and added to the gum-base by Manitole. In order to cover the bitter taste of the drug Aspartam, mint essence and Mentole were used. After gums production, the profile of drug dissolution was evaluated by jaw movement simulating system. It took 5 days to study each type of chewing gums without any mechanical plaque control method. Medicated and placebo chewing gums were identical in shape, size, color and formulation. The washout period was 2 days. Chewing gums were used every 12 hours for 20 minutes. To determine plaque score, Turesky- Gilmore- Glickman modification index was used. Other variables including: subjective evaluation of taste, cleansing effect and taste disturbance were assessed through filling a checklist. The data were analyzed by Paired t test and Wilcoxon test. During 20 mins, 80% of the drug was released from the gum-base. The mean difference of plaque score between the initial and final stages at the first trial was -0.1589 and at the second trial was 2.994 which was statistically significant (P<0.001). Subjective evaluation of cleansing effect showed statistically significant differences between the placebo and medicated chewing gum (PO.00I). There was no statistical significant difference between the subjective evaluations of taste (P-0.157). No taste disturbances were reported. In this investigation, the researchers could for the first time introduce new formulation for chlorhexidine medicated chewing gums with efficacy and anti-plaque effects coupled with an acceptable taste for public usage.