Patients and study procedure
allergy, pain
ALLERGY, CAVITY
This study was a double-blinded randomized clinical trial in 67 patients with HNCs undergoing RT in a tertiary referral hospital affiliated to medical university. After inspecting the oral cavity of the patients for any oral lesions, patients over 18 years of age with the oral mucosa within the range of radiation, and the minimum amount of radiation of 30 Gy were included in the study. At the initiation of the study, we assessed 75 patients for eligibility criteria. Eight patients were excluded from the study due to having one of the exclusion criteria: known allergy to the ingredients of the mouthwashes, previous history of receiving RT, use of any other mouthwash, consumption of oral zinc dietary supplements, or receiving analgesics. Eventually, statistical analysis was performed on the remaining 67 patients.At baseline, just the day before the first RT session, the demographical and baseline characteristics of each patient were recorded by the investigator of clinical responses. The eligible participants were randomly assigned into one of the following groups: zinc sulfate, polyherbal, chlorhexidine (Vi-one 0.2% CHX), or placebo mouthwash. Prior to the enrollment, demographic characteristics of the patients were recorded. Afterwards, the oral cavity of all patients was examined. Follow-up evaluation of oral hygiene was performed in all the participants weekly for seven consecutive weeks. The checklists of OM and the intensity of pain were filled out according to WHO assessment tool [Each patient was instructed to rinse 5 ml of the mouthwash three times a day for 60 s from the first day of starting RT, then poured it out. The patients were informed to continue their treatment for the following 6 weeks. Patients were evaluated weekly during RT by radiation oncologist and investigator of clinical responses. In these weekly follow-up sessions, mouthwash was provided to the patients for one week. Compliance to the treatment was assessed by requesting the patients to take the rest of their bottles to the weekly appointments. The oral cavity was examined and the incidence and severity of OM and intensity of pain was evaluated on a weekly basis (for an overall of seven follow-up sessions).