Investigation of antimicrobial effect of green tea and chlorhexidine mouthwashes on the frequency of Streptococcus mutans strains in children with removable orthodontic appliances: a randomized clinical trial study

Determining the antimicrobial effect of green tea and 0.2% chlorhexidine mouthwashes on the frequency of Streptococcus mutans strains in children with removable orthodontic appliances.

A randomized triple blind phase 3 clinical trial ,with the control group, block randomized parallel groups on 45 patients

Sampling is done from children referred to the orthodontic clinic of Kurdistan University of Medical Sciences. One group of participants receives chlorhexidine mouthwash 0.2% and another group receives green tea mouthwash. The control group receives deionized water. The participants under the intervention rinse the mouthwash for 15 days and twice a day with a volume of 5 ml and for 30 seconds. Saliva sampling from three groups of participants in the study is done in two stages, before and after using mouthwash. The samples are cultured and the colony count of the samples is done and the obtained data are evaluated and compared.

In this study, children who have used their appliance for more than a month and their cooperation in using the appliance has been favorable are included in the study. Children with allergies to mouthwash, systemic disease and a history of radiotherapy are prohibited from entering the study. Participating children must have a good health status and children with rampant caries and gum diseases and dental and oral infections are not included in the study.

The entry of participants into each group is random using the block method. Participants are divided into three groups A, B and C: two groups with clinical intervention(recipient of treatment) and one group as control(recipient of distilled water).

Streptococcus mutans colony count

Participants are divided into three groups A, B and C: two groups with clinical intervention(recipient of treatment) and one group as control(recipient of distilled water). Due to the small sample size in this study, the random block method will be used instead of the simple random method to allocate the number of participants to each group. In this method, at first, all possible states will be extracted from blocks of three, and then a number will be assigned to each block. At the end, blocks will be selected using random numbers. This block method helps to have an equal number of participants in each group.

To assign random numbers and perform blinding of patients and researchers, a senior student (who is not involved in the study) is designated as the operator. The operator is responsible for pouring the mouthwash into the bottle and assigning the type of mouthwash to each random number. All mouthwashes for blinding are delivered to the patients in the identical, dark, opaque and unlabeled medicine storage bottles with a volume of 100 ml. Bottles are given to the patient in a parcel, so the contents of the bottles cannot be distinguished by the observer. Only the patient's unique number is written on the mouthwash bottle and the collected saliva sample, and the way the patients are allocated will be kept confidential by the operator until the end of the study. The patient, the researcher, and the statistical analyst are blinded to the contents of the bottles. At the end of the study and performing the statistical comparison between the groups, the operator provides the information related to each of the three studied groups to the statistical analyst so that the final results can be reviewed and compiled.

All data is potentially shareable after unidentified individuals

Access starts after publishing the results

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Researchers have access to the data under any circumstances

For more information, you can contact the corresponding author via the following email: ramyar.gh01@gmail.com

The applicant has unlimited access to the data after sending the request via email to the corresponding author.