Anticalculus effect of a cetylpyridinium chloride/zinc gluconate mucoadhesive gel: results of a randomized, double-blind, controlled clinical trial.

OBJECTIVE: This randomized, double-blind, controlled clinical trial investigated the anticalculus effect of a cetylpyridinium chloride/ zinc gluconate (CPC/ZG) mucoadhesive gel. METHODOLOGY: The 80 adults from the San Francisco area who fulfilled the enrollment criteria were stratified based on total Volpe-Manhold Index (VMI) scores (low, medium, or high), gender, and other demographic data. Within these strata, they were randomly assigned to the CPC/ZG gel group or the placebo gel group, and underwent a baseline oral soft tissue (OST) examination. Subjects were dispensed Oral-B Indicator 35 Compact Head soft toothbrushes and Colgate Cavity Protection MFP toothpaste, and instructed to brush twice daily using these products. Every night for three months, following the nighttime brushing and just before retiring, subjects applied their assigned treatment gel to the lingual surfaces of the six mandibular anterior teeth. They were instructed not to eat or drink until morning and to avoid using other methods of interdental cleaning between the treated teeth, except to remove impacted food. Total VMI scores and OST examination findings obtained at three months were compared with baseline findings. RESULTS: Seventy-eight (78) of the 80 subjects complied with the protocol and completed the study. After three months of treatment, the CPC/ZG group showed a 30% decrease in mean VMI score compared with a 0% decrease in the placebo group. OST examination at three months revealed no serious adverse events in either group. CONCLUSION: Results of this clinical trial indicate that regular use of the CPC/ZG gel, with or without the use of floss or other interdental cleaning products, yields a statistically significant reduction in calculus.