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IRCT20240221061066N1 IRCT 2024-05-26 Sanandaj University of Medical Sciences Effect of green tea and chlorhexidine mouthwash in children with removable orthodontic appliances 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 2024-09-22 anticipated 45 Complete https://irct.ir/trial/76852 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: 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, Blinding description: 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. 4 Prevalence of Streptococcus mutans bacteria in saliva before and after using mouthwash. Intervention group: In this study, the children of the intervention groups are divided into two groups. One group of participants receives 0.2% chlorhexidine mouthwash and another group receives green tea mouthwash. Necessary instructions on how to use mouthwash will be given to the groups receiving the mouthwash. The participants under the intervention use the mouthwash for 15 days and twice a day (at night before bed and in the morning after breakfast) with a volume of 5 ml and for 30 seconds.. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access starts after publishing the results To whom: Researchers working in academic and scientific institutions Conditions: Researchers have access to the data under any circumstances Where to obtain: For more information, you can contact the corresponding author via the following email: ramyar.gh01@gmail.com How to obtain: The applicant has unlimited access to the data after sending the request via email to the corresponding author. Comments:
public Ramyar Qaderzade
Pasdaran
Sanandaj Iran (Islamic Republic of) 6617879947 +98 87 9999 7311 ramyar.gh01@gmail.com Sanandaj University of Medical Sciences scientific Shiva Abdollahi
Pasdaran
Sanandaj Iran (Islamic Republic of) 6617879947 +98 87 3346 7876 sh.abdollahi.dds@gmail.com Sanandaj University of Medical Sciences Iran (Islamic Republic of) Ensuring the cooperation of participants At least one month has passed since using the removable orthodontic appliance Optimal oral hygiene of the participants Healthy gum and oral environment of participating children Not having systemic disease and cleft palate Not having a report of oral and dental chronic infections in the last year Not reporting any allergy to mouthwash Not having any disability that interferes with the patient's health control 6 years 12 years Both Participants treated with steroidal and nonsteroidal anti-inflammatory drugs during the past three months Children treated with antiseptic, antibiotic, probiotic or prebiotic drugs during the last three months Non-cooperative participants with less than 8 hours of appliance use per day Rampant caries Use of mouthwash and fluoride therapy during the last month History of radiotherapy Prevention Intervention group: In this study, the children of the intervention groups are divided into two groups. One group of participants receives 0.2% chlorhexidine mouthwash and another group receives green tea mouthwash. Necessary instructions on how to use mouthwash will be given to the groups receiving the mouthwash. The participants under the intervention use the mouthwash for 15 days and twice a day (at night before bed and in the morning after breakfast) with a volume of 5 ml and for 30 seconds. Streptococcus mutans colony count. Timepoint: Before and 15 days after using mouthwash. Method of measurement: Counting bacterial colonies with a colony counter. Sanandaj University of Medical Sciences Approved 2024-05-19 Ethics committee of Kordestan University of Medical Sciences Pasdaran Street Sanandaj Kurdistan Iran (Islamic Republic of)