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IRCT20160117026069N10 IRCT 2024-01-27 Karaj University of Medical Sciences Investigating the effect of chewing gum containing postbiotic on the number of Streptococcus mutans bacteria in saliva Production and investigation of antibacterial effects of chewing gum containing postbiotic yeast Saccharomyces boulardi and its chewing effect on Streptococcus mutans levels in human saliva: a randomized controlled trial 2024-01-27 anticipated 90 Complete https://irct.ir/trial/75095 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Sealed envelopes are considered as the number of patients, whose content determines which group each person belongs to. One of these envelopes is selected for each patient by lottery, and then this envelope is opened and the allocation of the patient will be determined after opening the envelopes, Blinding description: In this study, the gums of all three groups are similar to each other and only the code assigned to them is different. Participants, clinical examiners, researchers, and laboratory personnel who have access to the collected samples and data, as well as the person performing the statistical analysis will be blinded to the coding of the groups until the disclosure of the codes after statistical analysis. 3 Dental decay. Intervention 1: Control group: Normal gum, twice a day for ten days. Intervention 2: Intervention group: Gums containing postbiotic, twice a day for ten days. Intervention 3: Control group: Gums containing xylitol, twice a day for ten days. Yes - There is a plan to make this available What will be shared: After submitting the request to the project manager, this request will be reviewed by a committee with the presence of all the people involved in the project, and then if the committee gives a positive answer, the data will be provided to the applicant. When: Access starts 6 months after results are published To whom: All researchers working in academic and scientific institutions and people working in the industry Conditions: If a request with this theme is received, a decision will be made with the opinion of the research team. Where to obtain: From the project manager, Dr. Hadi Pourjafar How to obtain: After submitting the request to the project manager, this request will be reviewed by a committee with the presence of all the people involved in the project, and then if the committee gives a positive answer, the data will be provided to the applicant. Comments:
public Hadi Pourjafar
Vice-Chancellor for Research and Technology, Golshahr, Safarian Alley
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 pourjafarhadi59@gmail.com Karaj University of Medical Sciences scientific Nadia Sadeghi
Vice-Chancellor for Research and Technology, Golshahr, Safarian Alley
Karaj Iran (Islamic Republic of) 3198764653 +98 26 3464 3705 drnadiasadeghi78@gmail.com Karaj University of Medical Sciences Iran (Islamic Republic of) All adults between 15 and 40 years old 15 years 40 years Both People who have been treated with antibiotics within two weeks before the start of the study Individuals with any active dental or gum disease within two weeks prior to the start of the study People who are allergic to any of the gum compounds K02 Dental caries Prevention Prevention Prevention Control group: Normal gum, twice a day for ten days Intervention group: Gums containing postbiotic, twice a day for ten days Control group: Gums containing xylitol, twice a day for ten days Streptococcus mutans bacteria count in saliva. Timepoint: Before the study, ten days after the study. Method of measurement: Culture and bacterial count. Karaj University of Medical Sciences Approved 2023-12-02 Ethics committee of Alborz University of Medical Sciences Saffarian Alley, Golshahr Blvd, Karaj Karaj Alborz Iran (Islamic Republic of)