Comparing of toll like receptor 2 salivary level in head and neck radiotherapy patients with and without probiotic treatment

Comparison of the mean salivary level of Toll like receptor 2 between the two groups with and without probiotics

The clinical trial will have a control group, with parallel groups, three blinded, randomized, phase 3 on 50 patients randomly and by the method of randomized permutation blocks with variable size of variable block 4 and 6 .

The clinical efficacy study is conducted in the Department of Cancer Institute of Imam Khomeini Hospital in a three-way blinded manner (patient, evaluator and statistical analyst) by receiving the saliva of patients and checking the level of TLR2 in two groups.

Inclusion criteria: Patients with oral squamous cell cancer referred to the Imam Khimni Hospital Cancer Institute who were diagnosed and operated on the basis of histopathology and are scheduled to undergo IMRT; Patients aged 18 years and older. Exclusion criteria: Lack of written informed consent to participate in the study; Suffering from systemic diseases such as rheumatoid arthritis/hypertension/leukemia/systemic lupus erythromatous and other types of systemic diseases; Having another malignancy and being treated for it; Patients who have already received chemotherapy or are undergoing chemotherapy; Pregnant and lactating women.

Control group: placebo group. Intervention group: Probiotic mouthwash group.

The expression level of Toll like receptor 2

The method of assigning drugs to patients will be randomly and by random permutation blocks with a block size of 4 and 6 changes. The random list will be obtained manually and using the tables in the book "Design and Analysis of Clinical Trials" which is provided under its reference. The random list preparation method will be as follows: In the present study, placebo and probiotic groups (2 groups) were consideredPatients enter the study in order and they are assigned a code according to the order of their entry (codes 1 to 44). To make the first block (for example: a block of size 4), the numbers 1, 2, 3, and 4 are randomized. For example, the order of randomization is 2, 4, 1 and 3, in this case, in the probiotic group, patients with codes 2 and 4 and in the placebo group, patients with codes 1 and 3 are included. To make the second block (for example: a block of size 6), the numbers 5, 6, 7, 8, 9 and 10 are randomized. Suppose the order of randomization is 10, 7, 9, 5, 6 and 8. In this case, in the probiotic group, patients with codes 10, 7, 9 and in the placebo group, patients with codes 5, 6, and 8 are included in the study. This work will be done until all the blocks are obtained and the sample size of 22 people in each group is reachedIn order to conceal the allocation, sealed envelopes are prepared, the contents of which are not known, and envelope numbers 1 to 44 are inserted. Inside each envelope, based on the list of random numbers, the name of the group to which the person will be assigned is mentioned. It should be noted that this step will be performed by a person who has no role in the evaluation of patients. (1) 1. Fleiss JL. Design and analysis of clinical experiments: John Wiley & Sons; 2011.

This study will be done in a three-way blind. In this research, the patient, the evaluator (the person who measures the results of the study) and the statistical analyst (dissertation statistics consultant) will be uninformed (blind) of the groups under study. The two drugs used in this research are mouthwashes of the same color with the same smell and temperature, which are placed in containers with the same weight and the same appearance, and are numbered by the pharmacist based on a random list. Each patient who enters the study (in the order of patients' entry) is assigned a code and receives the medicine corresponding to that code. Neither the evaluating dentist nor the patient will know the contents of the packages (because each package has a code and only the manufacturer of the drugs will know the contents of the packages). And the nature of the drugs will be revealed after analyzing the results.