Therapeutic efficacy of chlorhexidine‐based mouthwashes and its adverse events: Performance‐related evaluation of mouthwashes added with Anti‐Discoloration System and cetylpyridinium chloride

• Published in: International journal of dental hygiene Vol. 17; no. 3; pp. 229 - 236
• Main Authors: Guerra, Fabrizio, Pasqualotto, Debora, Rinaldo, Francesca, Mazur, Marta, Corridore, Denise, Nofroni, Italo, Ottolenghi, Livia, Nardi, Gianna Maria
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.08.2019
• Subjects: Anti-Infective Agents, Local; Anti‐Discoloration System; Burning; Cetylpyridinium; Cetylpyridinium chloride; Chlorhexidine; chlorhexidine digluconate; Dental Plaque; Gingiva; Gingival bleeding index; Gingivitis; Humans; mouthwash; Mouthwashes; Oral hygiene; Side effects; Statistical analysis; chlorhexidine digluconate; cetylpyridinium chloride; mouthwash; Anti-Discoloration System
• ISSN: 1601-5029; 1601-5037
• DOI: 10.1111/idh.12371

Objectives To compare 3 mouthwashes: 0.20% chlorhexidine (CHX) with Anti‐Discoloration System (ADS), 0.20% CHX and 0.12% CHX with 0.05% cetylpyridinium chloride (CPC), in terms of reduction of plaque and gingival bleeding and side effects. Methods Mild gingivitis patients were randomly divided into three Groups: they underwent professional oral hygiene and received instructions: oral rinse with 10 mL for 1', twice a day, 30' after tooth brushing, for 14 days. Primary outcomes were plaque and gingival bleeding, assessed with Plaque Control Record and Gingival Bleeding Index. Feedback questionnaire and spectrophotometer evaluated secondary outcomes: adverse events. Timing of the study was T0 (baseline), T1 (professional oral hygiene) and T2 (14th day after mouthwash use). Results Sixty‐six patients were recruited, two patients dropped out, and 64 patients completed the study. PCR T1‐T2 mean variation was 30.67 (SD = 15.22; 95% CI 23.55 to 37.80; P = 0.000), 19.93 (SD = 11.03; 95% CI 14.90 to 24.95; P = 0.000) and 16.24 (SD = 15.35; 95% CI 9.60 to 22.88; P = 0.000) respectively in Groups 0.2% CHX + ADS, 0.2% CHX and 0.12% CHX + CPC. GBI mean variation (T0‐T2) was −9.82 (SD = 9.27; 95% CI −5.48 to 14.16; P = 0.000), −19.31 (SD = 11.33; 95% CI −14.15 to −24.47; P = 0.000) and −21.13 (SD = 12.56; 95% CI −15.70 to −26.56; P = 0.000) respectively in Groups 0.2% CHX + ADS, 0.2% CHX and 0.12% CHX + CPC. Statistical significance was found in lower efficacy of 0.2% CHX + ADS Group. Patients tolerated 0.12% CHX + CPC mouthwash better in bleeding perception (95.5%; P = 0.046), burning sensation (13.6%; P = 0.006), and mouthwash taste (100%; P = 0.000). Results on staining were no statistically significant (P = 0.106). Conclusions Addition of CPC allows reduction of CHX percentage in mouthwash formulation while keeping equal efficacy and less side effects. ADS addition decreases CHX efficacy in reducing plaque and bleeding, while resulting more tolerated than CHX.