Comparison of Clinical Effects of Essential Oil–Containing Mouthwash and Chlorhexidine Mouth Wash in Patients Undergoing Fixed Orthodontic Treatment – Three‐Month Follow‐up Randomized‐Controlled Trial

Abstract

ABSTRACT Objective This study aimed to compare the clinical effects of chlorhexidine (CHX) and essential oil–containing mouthwash (EOM) on periodontal health in patients undergoing fixed orthodontic treatment over a 3‐month follow‐up period. Material and Methods This double‐blinded, parallel‐arm randomized‐controlled clinical trial with a 1:1 allocation ratio was conducted at the Department of Orthodontics, Saidu College of Dentistry, Swat, Pakistan. Sixty participants aged 13–40 years undergoing fixed orthodontic treatment were randomly allocated to receive either 0.12% chlorhexidine mouthwash or Listerine essential oil mouthwash, dispensed in identical coded containers to ensure blinding. Participants were instructed to rinse with 10 mL of the assigned mouthwash twice daily for 30 s for 3 months while maintaining routine oral hygiene practices. The primary outcomes were the plaque index and the gingival index. Tooth staining was assessed as a secondary outcome (harm). Clinical outcomes, including the plaque index, the gingival index, and the stain index, were recorded at baseline, 1, 2, and 3 months by a calibrated examiner. Data were analyzed using generalized estimating equation models to evaluate longitudinal changes between groups, with statistical significance set at p ≤ 0.05. Results The gingival index showed a significant change over time (Wald p = 0.02), with no statistically significant overall difference between the CHX and Listerine groups (Wald p = 0.07). The plaque index was significantly higher in the CHX group than in the Listerine group (Wald p < 0.001). The stain index was also significantly higher in the CHX group than in the Listerine group (Wald p < 0.001). Conclusion Both mouthwashes were associated with changes in periodontal health during fixed orthodontic treatment. Compared with CHX, EOM was associated with significantly lower plaque index and stain index scores, whereas no statistically significant overall difference between groups was observed for the gingival index. Trial Registration: This trial was retrospectively registered at ClinicalTrials.gov (Identifier: NCT07119840).