Inhibition of de novo plaque growth by a new 0.03% chlorhexidine mouth rinse formulation applying a non-brushing model: a randomized, double blind clinical trial.

Abstract

The aim of this study was to investigate the plaque inhibitory effect of a new 0.03% chlorhexidine digluconate (CHX) and 0.05% cetylpyridinium chloride (CPC) mouthrinse formulation and to explore patients' experience and side effects after its use. This short-term, randomized, double blind, parallel, clinical trial enrolled 150 periodontally healthy patients. These volunteers were randomly allocated to one of following mouthrinse groups (n=50/group): 0.12% CHX+0.05% CPC (Perio-Aid® Treatment alcohol-free), 0.03% CHX+0.05% CPC new test formulation or to the placebo group. Clinical parameters (plaque, gingival, and stain indexes) and microbiological samples were taken at baseline, before supragingival cleaning, and after 4days of undisturbed plaque growth, rinsing twice/day with one of the mouthrinses. Plaque reduction was similar for the 0.12% CHX (-0.52±0.55) and 0.03% CHX (-0.47±0.49) groups. Both showed significant reductions in plaque accumulation compared to the placebo (p<0.001). The new formulation had less of a negative impact on taste perception when compared to the 0.12% CHX solution. The new CHX mouthrinse was also able to control bacterial loads and reduce some periodontopathogens. This study indicated that the new 0.03% CHX+0.05% CPC formulation exerted clinical efficacy similar to that achieved by an already-marketed 0.12% CHX+0.05% CPC mouthrinse, but with slightly fewer side effects. Lower CHX mouthrinse formulations could be effective in the inhibition of plaque regrowth with reduced unpleasant subjective side effects.