Carolina Mor-Reinoso1, Andres Pascual2, Jose Nart1, Marc Quirynen3. 1. Department of Periodontology, Hospital General de Catalunya, Universitat Internacional de Catalunya, C/ Josep Trueta s/n, C.P. 08195, Sant Cugat del Vallès, Barcelona, Spain. 2. Department of Periodontology, Hospital General de Catalunya, Universitat Internacional de Catalunya, C/ Josep Trueta s/n, C.P. 08195, Sant Cugat del Vallès, Barcelona, Spain. pascuallarocca@hotmail.com. 3. Departments of Oral Health Sciences and Periodontology, Katholieke Universiteit Leuven, University Hospitals & Dentistry Leuven, Leuven, Belgium.
Abstract
OBJECTIVES: 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. MATERIALS AND METHODS: 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 4 days of undisturbed plaque growth, rinsing twice/day with one of the mouthrinses. RESULTS: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. CONCLUSIONS: 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. CLINICAL RELEVANCE: Lower CHX mouthrinse formulations could be effective in the inhibition of plaque regrowth with reduced unpleasant subjective side effects.
RCT Entities:
OBJECTIVES: 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. MATERIALS AND METHODS: 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 4 days of undisturbed plaque growth, rinsing twice/day with one of the mouthrinses. RESULTS: 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. CONCLUSIONS: 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. CLINICAL RELEVANCE: Lower CHX mouthrinse formulations could be effective in the inhibition of plaque regrowth with reduced unpleasant subjective side effects.