Abstract
BACKGROUND: Orthodontic treatment can cause traumatic ulcers within the first month due to friction and irritation. Curcumin, a turmeric extract, exhibits analgesic, anti-inflammatory, antibacterial, and wound-healing properties. This study investigated the effectiveness of curcumin mouthwash in preventing traumatic ulcers in fixed orthodontic patients during the first month of treatment. METHODS: In this double-blind, placebo-controlled, randomized clinical trial, 70 patients aged 12-30 years were assigned to curcumin or placebo mouthwash, used twice daily for 28 days after bracket cementation. Primary outcomes were (1) incidence and (2) duration of traumatic ulcers. Secondary outcomes included pain scores, ulcer sites, adverse effects, plaque index (PI), gingival index (GI), gingival bleeding index (GBI), and patient feedback. Data were analyzed using descriptive statistics and SPSS software. RESULTS: All 70 patients completed the trial, with 35 participants in the curcumin group (mean age 20.88 ± 4.87 years) and 35 in the placebo group (mean age 18.60 ± 4.20 years). No significant between-group differences were observed in the incidence or duration of traumatic ulcers (p > 0.05). Patients in the curcumin group reported significantly lower pain scores compared with those in the placebo group during the first and second weeks (p < 0.05), indicating an early analgesic effect; however, no significant differences were observed thereafter. The buccal mucosa was the most frequent ulcer site, and orthodontic wax use did not differ significantly between groups (p > 0.05). No adverse effects were reported in the curcumin group, and participants rated its smell as more pleasant. Baseline PI was lower in the curcumin group (p < 0.05), but no post-intervention differences were observed (p > 0.05). Within-group analyses showed a PI reduction in the placebo group and a GI reduction in the curcumin group (both p < 0.05), while GBI remained unchanged. CONCLUSIONS: Although ulcer prevention was not observed, curcumin mouthwash may serve as an adjunct for early pain relief in orthodontic patients. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT05147376), registered on December 7, 2021. Available at: https://clinicaltrials.gov/study/NCT05147376 .