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IRCT20170502033770N3 IRCT 2023-06-20 Mazandaran University of Medical Sciences The comparison of the effects of protact mouthwash with chlorhexidine on Streptococcus in orthodontic patients The comparison of the effects of protact mouthwash with chlorhexidine on Streptococcus mutans attached to orthodontic elastic rings 2023-06-17 anticipated 22 Complete https://irct.ir/trial/70324 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random block method will be used to assign samples to groups (type of mouthwash). First, the samples will be matched in terms of age, gender, periodontium condition and oral hygiene and people with similar status will be placed in a block. According to the total number of required samples (22 samples) and the number of mouthwashes, finally 11 blocks with matched samples will be considered as 2 samples in each block (number of mouthwashes). Selection of blocks and type of mouthwash for each sample will be done through random allocation software 2 and the samples will be placed in one of the groups by this software, Blinding description: The study is double-blind. In order to blind patients, therapists and researchers, mouthwashes are placed in dark-colored bottles with the same appearance with different labels and according to the recommendations of the manufacturers, the mouthwash instructions leaflet is given to the patients in identical envelopes with different labels according to the mouthwash label, and the patients are asked to use the relevant mouthwash according to the leaflet. N/A Dental caries and gingivitis caused by Streptococcus mutans bacterial plaques. Intervention 1: The intervention group will be given Protact mouthwash (Daneshgar Zolang Respina pharmaceutical company) and the patients will be required to use 5 ml of their mouthwash for 30 seconds to one minute twice a day (morning and night) for 20 days. and avoid eating and drinking for an hour after that. All patients will be given the same Oral_B toothbrush and toothpaste, and they will be taught proper mechanical hygiene (at least twice a day). Intervention 2: Control group: The control group will be given 0.2% chlorhexidine mouthwash (Iran Najo Pharmaceutical Company) and the patients will be required to use 5 ml of their mouthwash for 30 seconds to one minute twice a day (morning and night) for 20 days. and avoid eating and drinking for an hour after that. All patients will be given the same Oral_B toothbrush and toothpaste, and they will be taught proper mechanical hygiene (at least twice a day). Yes - There is a plan to make this available What will be shared: After the completion of the project, the results will be delivered in the form of a final report and in electronic form (on a CD) to the Vice-Chancellor of Research and Faculty of Dentistry of Mazandaran University of Medical Sciences. When: The decision regarding access to the data will be the responsibility of the vice president of research and the Faculty of Dentistry of Mazandaran University of Medical Sciences, as well as the supervisor. To whom: Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also the supervisor Conditions: The request should be sent to the responsible person after consultation with the research team, the data will be provided to the requesting person, and it is necessary to give reference to the data owners in the articles or wherever the data is to be used, and the use of the results only It is allowed by citing its source. Where to obtain: Vice President of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also the supervisor How to obtain: A written request to the vice president of research or the Faculty of Dentistry of Mazandaran University of Medical Sciences and also obtaining the consent of the supervisor. Comments:
public Hodis Ehsani
Khazar Blvd, Sari Faculty of Dentistry
Sari Iran (Islamic Republic of) 4816895475 +98 11 3325 4135 hehsani@mazums.ac.ir Mazandaran University of Medical Sciences scientific Hodis Ehsani
Khazar Blvd, Sari Faculty of Dentistry
Sari Iran (Islamic Republic of) 4816895475 +98 11 3325 4135 hehsani@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Patients without periodontitis Patients with appropriate cooperation Patients with a minimum age of 15 years 15 years no limit Both Patients using any antibiotics and mouthwash during the last three months for 10 consecutive days Patients taking corticosteroids Patients with mouthwash allergy Treatment - Drugs Treatment - Drugs The intervention group will be given Protact mouthwash (Daneshgar Zolang Respina pharmaceutical company) and the patients will be required to use 5 ml of their mouthwash for 30 seconds to one minute twice a day (morning and night) for 20 days. and avoid eating and drinking for an hour after that. All patients will be given the same Oral_B toothbrush and toothpaste, and they will be taught proper mechanical hygiene (at least twice a day). Control group: The control group will be given 0.2% chlorhexidine mouthwash (Iran Najo Pharmaceutical Company) and the patients will be required to use 5 ml of their mouthwash for 30 seconds to one minute twice a day (morning and night) for 20 days. and avoid eating and drinking for an hour after that. All patients will be given the same Oral_B toothbrush and toothpaste, and they will be taught proper mechanical hygiene (at least twice a day). The number of Streptococcus mutans bacteria. Timepoint: in three occasions, before consumption, immediately after consumption and after 20 consecutive days of consumption. Method of measurement: Separation and collection of elastic rings. Mazandaran University of Medical Sciences Approved 2022-07-06 Ethics committee of Mazandaran University of Medical Sciences Khazar Blvd, Sari Faculty of Dentistry (Tooba dental clinic) Sari Mazandaran Iran (Islamic Republic of)