Participants and study procedure
infection, Toxicity
INFECTION, SYSTEMIC DISEASE
This study was designed as a 3-group, single-blind, placebo-controlled phase II preliminary randomized clinical trial. The assessor of clinical symptoms was blinded to the intervention assignments during the study. Inclusion criteria were as follows: Patients with mild to moderate ROM (Grade 1 to 3) over the age of 18 who received the minimum radiation dose of 50 g during the entire study. In addition, patients with the following conditions were removed from the study: uncontrolled underlying systemic disease, smoking, serious dental problems, receiving other concomitant treatments for OM, simultaneous treatment of chemotherapeutic drugs, OM severity rated 4 on a 1-to-4 WHO scale and active infection.Forty-five eligible participants were registered and randomized using a computer-generated random list in a 1:1:1 ratio to receive one of the three interventions: curcumin mouthwash (0.1% w/v); Sinacurcumin soft gel containing 40 mg curcuminoids as nano-micelles (SinaCurcumin®40); or placebo mouthwash with a similar transparent appearance to curcumin mouthwash. Sinacurcumin soft gel (SinaCurcumin®40) was purchased from Exir Nano Sina Pharmaceutical Company. The treatment protocol was initiated within 48 h of enrollment. All the patients were asked to use 10 ml of freshly prepared mouthwashes 3 times a day or one capsule of SinaCurcumin®40 once a day for up to 21 days.The severity of OM was assessed using the WHO Oral Toxicity Scale [