Efficacy of a zinc mouthwash in prevention of head and neck radiotherapy-induced-oral mucositis: A double-blind randomized placebo-controlled trial

Zinc mouthwash in preventing mucositis

Clinical practice includes control group, and two parallel, double blinded and randomized groups.

This study is a cohort, blind, randomized controlled trial of 75 patients randomly divided into three groups of 25 controls or interventions. After random selection of patients, they will receive written consent (after explaining its content by the student) and eligible patients will be randomly assigned to one of the interventions by permutation blocks (each group is 25) Group 1: Zinc sulfate mouthwash, Group 2: Placebo mouthwash and Group III oral chlorhexidine. Each patient uses a group of mouthwashes three times a day for 6 weeks. Patients attending the study will be selected from randomly assigned patients to Radiation Clinic of Imam Ali Hospital in Bojnourd. The radiotherapist doctor who is responsible for recording the degree of mucositis and the patient as well as the student responsible for completing the questionnaires, are also unaware of the type of treatment intervention performed in relation to the patient.

Entry requirement: age over 18 undergoing head and neck radiotherapy excluding conditions: co-existing systematic diseases

Intervention group: 1% zinc sulfate, 1% of wetting factors, surfactants, and various suppositories (methyl cellulose, hydroxypropylmethyl cellulose, xanthan gum) will be used to produce mouthwash. Control group: For the preparation of placebo mouthwash, different factors such as water, ethanol, glycerin, citric acid, methyl paraben and propylene paraben are used. Chlorhexidine mouthwash (Vi-one 0.2% CHX) is prepared as a ready-to-use preparation. Chlorhexidine mouthwash is used as a positive control.

mucositis based on clinical manifestations, severity of mucositis, pain intensity

After random selection, each group will be identified based on the randomized table. In order to receive one of the interventions, they are randomly divided into permutational blocks. The radiotherapist is responsible for recording the degree of mucositis and the participants will not be informed of any grouping. Also, students who are responsible for completing the questionnaires are also unaware of the type of treatment interventions The physician who is aware of the study and the type of medication will be told the method of selecting and assigning samples based on a randomized table of numbers and each group will be followed up through random selection.

This study was a cohort, double-blinded, randomized controlled clinical trial And will be performed on 75 patients who will be randomly assigned to three 25-patient groups of control or intervention. After completing the preparation of the products, the first performer places mouthwashes in 120-cc glasses for one week use of the patients and identifies them with codes A, B or C. The radiotherapists who are responsible for recording the degree of mucositis and the patient will not be aware of any groupings done. Also, the student responsible for completing the questionnaire is also unaware of the type of medical interventions Given the double-blindness of the study, the treatments will be covered in form A, B, C. The doctor who is aware of the study and the type of medication, will be told the method of selecting and assigning samples based on a randomized table of numbers and each group will be followed up through random selection.