Journal of Dental Medicine (Aug 2003)
A study on the design, formulation and effectiveness of chewing gums containing Chlorhexidine Gluconate in the prevention of dental plaque
Abstract
Statement of Problem: The role of the microbial plaque in caries etiology and periodontal diseases has been"nproved and the mechanical methods for plaque control have special limitations, consequently, chemical"nmethods have been suggested. One of the most effective materials is Chlorhexidine Gluconate that is"ncommonly used as mouth rinses. However, the medicated formulations of chewing gums, due to several"nproperties, have been paid attention. It should be noted that a new formulation to satisfy the consumers' taste"nseems necessary."nPurpose: The aim of this study was to present a new formulation for chewing gums containing chlorhexidine"nto achieve a pleasant taste coupled with their effectiveness and anti-plaque properties maintenance."nMaterials and Methods: In this double blind, crossover, prospective clinical trial, 18 volunteers were"ninvestigated. Chlorhexidine Gluconate was used and added to the gum-base by Manitole. In order to cover the"nbitter taste of the drug Aspartam, mint essence and Mentole were used. After gums production, the profile of"ndrug dissolution was evaluated by jaw movement simulating system. It took 5 days to study each type of"nchewing gums without any mechanical plaque control method. Medicated and placebo chewing gums were"nidentical in shape, size, color and formulation. The washout period was 2 days. Chewing gums were used"nevery 12 hours for 20 minutes. To determine plaque score, Turesky- Gilmore- Glickman modification index"nwas used. Other variables including: subjective evaluation of taste, cleansing effect and taste disturbance were"nassessed through filling a checklist. The data were analyzed by Paired t test and Wilcoxon test."nResults: During 20 mins, 80% of the drug was released from the gum-base. The mean difference of plaque"nscore between the initial and final stages at the first trial was -0.1589 and at the second trial was 2.994 which"nwas statistically significant (P<0.001). Subjective evaluation of cleansing effect showed statistically"nsignificant differences between the placebo and medicated chewing gum (PO.00I). There was no statistical"nsignificant difference between the subjective evaluations of taste (P-0.157). No taste disturbances were"nreported."nConclusion: In this investigation, the researchers could for the first time introduce new formulation for"nchlorhexidine medicated chewing gums with efficacy and anti-plaque effects coupled with an acceptable taste"nfor public usage.
