The effect of Misswake herbal mouthwash (containing clove and lavender extracts) on periodontal indices and salivary interleukin 1 beta biomarkers in children with cystic fibrosis: A Randomized Clinical Trial

Determining the effect of Misswake herbal mouthwash (containing clove and lavender extracts) on periodontal indices and salivary interleukin 1 beta biomarker in children with cystic fibrosis.

A double-blind parallel clinical trial, randomized by the Block Allocation, with 44 sample size, which includes 22 people in each intervention and control group.

Cystic fibrosis patients aged 6 to 12 years in the CF clinic of Akbar Hospital in Mashhad city are divided into two intervention and control groups using block randomization.The order of patients in 44 envelopes is set as A or B.In the faculty,first saliva sampling and transferring it to the research institute by a third person, then periodontal gingival index (GI), plaque index (PI), simplified oral hygiene index (SOHI), prophylaxis, fluoride therapy and oral health education (toothbrush and toothpaste) for children is done by the second person.Mouthwash is given to the intervention group by an external observer. Blinding has been done for the laboratory analyst and the second and third person.

The Inclusion criteria include a child aged 6 to 12 years with a definitive diagnosis of cystic fibrosis, moderate severity of cystic fibrosis (spirometry criteria), no mental problems and metabolic and endocrine diseases, and not used oral and dental antimicrobial products in past 6 months. Exclusion criteria include the child's non-cooperation during the 4-week follow-up period, the use of analgesics during this period, and a change in the use of antibiotics.

Control group: examination of periodontal indices, prophylaxis, fluoride therapy, oral hygiene education (toothbrush and toothpaste) and saliva sampling. Intervention group: all previous cases plus giving mouthwash and teaching how to use it

PI, GI, SOHI, salivary interleukin 1-B

Randomization is done in the form of random Block Allocation by the analyser. Conventionally, code A is assigned to patients in the control group and code B to patients in the intervention group. According to the size of the sample, the size of the blocks is considered to be 4, 2, and 6, and the number of each of these types of blocks is determined by the individual. The analyser randomly places A and B codes in the blocks. Also, the number of codes in each block is the same. Codes A and B are written in 44 envelopes based on the result of random block formation, respectively, by analyser and delivered to the external observer. In the meeting of patients visiting the hospital, the external observer opens the envelope related to the patient in the order of patients' selection and is placed in the process of grouping the patient. Due to the fact that placebo will not be used in this study, blinding of patients will not be done sufficiently. However, in order to minimize the exposure of the patients of the two groups, after randomization, the external observer will invite the patients of the control and intervention groups to the dental school on two different days. It should be noted that the outcome assessor (the second researcher) and the third researcher will not be involved in the grouping of patients. (RCT Allocation Concealment)

The design of this study is a double-blind parallel clinical trial by assessor and analyst. - The first researcher/external observer (M. V) for the purpose of blinding, the evaluator is the only person who is in the process of dividing the groups (the patient's code represents his grouping), so the delivery of mouthwash and follow-up of the patients in the last stage is the responsibility of this person. - The second researcher/outcome assessor (S. A) is responsible for evaluating periodontal indicators, health education and prophylaxis-fluoride therapy of patients of both groups. - The third researcher (K.J.) is responsible for saliva sampling and delivering it to Booali Research Institute. The outcome assessor (the second researcher) and the third researcher will not be involved in the grouping of patients. Due to the fact that placebo will not be used in this study, blinding of patients will not be done sufficiently. However, in order to minimize the exposure of the patients of the two groups, after randomization, the external observer will invite the patients of the control and intervention groups to the dental school on two different days. Also, in the consent form of the guardian of the child, the title "promoting oral hygiene" is used.