Efficacy of a mouthwash containing standardized Centella asiatica extract (ECa 233) in patients with gingivitis: A randomized double-blind placebo-controlled trial

Background: Gingivitis is the earliest and most reversible stage of periodontal disease, characterized by inflammation of the gingiva caused by the accumulation of plaque. In addition to removing plaque, mouthwash containing antiseptic or anti-inflammatory could be used as an adjunct therapy.Objectives: The objective of this study is to evaluate the efficacy of a 0.10% standardized Centella asiatica extract (ECa 233) mouthwash compared to 0.12% chlorhexidine and placebo mouthwashes in individuals with gingivitis. Materials and Methods: A randomized, double-blind, placebo-controlled clinical trial was conducted in 75 patients assigned equally to ECa 233, chlorhexidine, or placebo groups. Participants used the assigned mouthwash twice daily for 14 days. Gingival and plaque indices were assessed at baseline, day 7, and day 14 using the modified gingival index (MGI), gingival bleeding index (GBI), and modified Quigley-Hein plaque index (MQH). Satisfaction was evaluated using a five-point Likert scale. Results: Intergroup comparisons revealed no statistically significant differences among the three study groups in primary gingival outcomes at any time point (P > 0.05). Within-group analysis showed a significant reduction in MGI scores at day 14 compared with baseline in the ECa 233 group (P < 0.05), whereas no significant intragroup changes were observed in the other groups. For plaque accumulation assessed by MQH, the ECa 233 group demonstrated a significant intragroup reduction by day 7 (P < 0.05); however, intergroup differences were not statistically significant. GBI scores did not differ significantly among groups, and no statistically significant group time interaction was detected (P > 0.05). All participants completed the study, and no adverse effects were reported. Subject satisfaction scores were high across all groups, with no statistically significant differences among them (P > 0.05). Conclusion: Within the limitations of this randomized controlled trial, the 0.10% ECa 233 mouthwash was well tolerated and associated with intragroup reductions in gingival inflammation and plaque accumulation over time. However, no statistically significant differences were observed between the ECa 233, chlorhexidine, and placebo groups. These findings suggest that ECa 233 may have potential as an adjunctive option for gingivitis management.