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IRCT20210811052147N1 IRCT 2021-10-17 Esfahan University of Medical Sciences Evaluation of the effects of Streptococcus salivarius M18 and K12 probiotic bacteria on the amount of Streptococcus mutans in saliva: a randomized clinical trial Evaluation of the effects of Streptococcus salivarius M18 and K12 probiotic bacteria on the amount of Streptococcus mutans in saliva: a randomized clinical trial 2021-10-20 anticipated 40 Complete https://irct.ir/trial/59305 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Individuals are randomly divided into 2 groups of 20 people. In order to maintain the equality of the number of people in both groups, in this study, the limited randomization method of block randomization will be used. Blocking is usually used to balance the number of samples assigned to each of the study groups. This feature helps researchers to equate the number of samples assigned to each of the study groups in cases where intermediate analyzes are required during the sampling process. The size of all the blocks is the same and in this two-group experiment we will have 40 blocks of 20 people including 20 people in the probiotic group and 20 people in the control group (mouth freshener pill).The randomization tool will be the latest version of random allocation software, which in addition to simple randomization will also be able to block randomization. We also use allocation concealment, which is the method used to execute random sequences on study participants so that the assigned group is not known before the individual is assigned. Using opaque envelopes sealed with random sequence (Sequentially numbered, sealed, opaque envelopes) in which in this method each random sequence is recorded on a card and the cards are inside the envelopes respectively. Are placed. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lids of the letter envelopes are glued and placed inside a box, respectively. At the beginning of the registration of participants, based on the order of entry of eligible participants into the study, one of the envelopes of the letter is opened in order and the assigned group of the participant is revealed. 3 Dental caries. Intervention 1: Intervention group: to standardize oral hygiene, both intervention and control groups are given brushing training one week before the intervention. People also use a type of toothpaste for a week before the intervention and at the end of the entire intervention period. Individuals take a tablet containing the probiotic bacteria Streptococcus salivarius M18 and K12 in their mouth every night before going to bed and suck it until it dissolves and consume this substance for 20 days. This tablet is under the brand name of Lactogam and is a product of Zist Takhmir Company and is made in Iran. These tablets contain 150 mg of M18 bacteria and 150 mg of K12 bacteria. Also, more than 10 to the power of 9 colonies of these bacteria are present in each tablet. The taste of this pill is mint. Intervention 2: Control group: to standardize oral hygiene, both intervention and control groups are given brushing training one week before the intervention. People also use a type of toothpaste for a week before the intervention and at the end of the entire intervention period. Individuals put a mouthwash pill in their mouth at night before going to bed and suck it until it dissolves and consume this substance for 20 days. This pill is under the brand name of Iceberg and made in Iran in Shiva food industry. The sweetener in this pill is xylitol and it is unusable for bacteria in the mouth. Also, the dose of xylitol in each deodorant pill is extremely low and has no therapeutic effect of xylitol. The taste of this pill is mint. Yes - There is a plan to make this available What will be shared: All our data except people names and phone numbers can be published When: The data will be available 1 year after the results are published. To whom: The data is accessible to academic researchers and industry researchers. It should be noted that this information will be available only to Iranian universities and companies. Conditions: If the data is not deleted and changed and the purpose of using the data is clear to the early researchers, it is possible to use the data at the discretion of the early researchers. It should be noted that in case of any discrepancy with moral principles or having bad intentions, this information will not be provided to individuals. Where to obtain: Dr. Firoozeh Nilchian Address: School of Dentistry, Isfahan University of Medical Sciences Phone: 00983137925594 Email: f_nilchian@dnt.mui.ac.ir Postal Code: 8174673461 How to obtain: The application must be mentioned by phone number or email. Then, if the initial researchers agree, the necessary information will be provided to the applicants as soon as possible. Comments:
public Firoozeh Nilchian
School of Dentistry , Isfahan University of Medical Sciences , Hezar Jarib Boulvard, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5594 f_nilchian@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Firoozeh Nilchian
School of Dentistry , Isfahan University of Medical Sciences , Hezar Jarib Boulvard, Isfahan, Iran
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5594 f_nilchian@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) People without orthodontics or people who have had orthodontic treatment for more than six months People who have not taken antibiotics in the past month People who do not have incomplete dental treatment People without immune system diseases 19 years 35 years Both People with orthodontic appliques or people who have had orthodontic treatment for less than six months People who have taken antibiotics in the past month People undergoing incomplete dental treatment People with immune system diseases K02 Dental caries Prevention Placebo Intervention group: to standardize oral hygiene, both intervention and control groups are given brushing training one week before the intervention. People also use a type of toothpaste for a week before the intervention and at the end of the entire intervention period. Individuals take a tablet containing the probiotic bacteria Streptococcus salivarius M18 and K12 in their mouth every night before going to bed and suck it until it dissolves and consume this substance for 20 days. This tablet is under the brand name of Lactogam and is a product of Zist Takhmir Company and is made in Iran. These tablets contain 150 mg of M18 bacteria and 150 mg of K12 bacteria. Also, more than 10 to the power of 9 colonies of these bacteria are present in each tablet. The taste of this pill is mint. Control group: to standardize oral hygiene, both intervention and control groups are given brushing training one week before the intervention. People also use a type of toothpaste for a week before the intervention and at the end of the entire intervention period. Individuals put a mouthwash pill in their mouth at night before going to bed and suck it until it dissolves and consume this substance for 20 days. This pill is under the brand name of Iceberg and made in Iran in Shiva food industry. The sweetener in this pill is xylitol and it is unusable for bacteria in the mouth. Also, the dose of xylitol in each deodorant pill is extremely low and has no therapeutic effect of xylitol. The taste of this pill is mint. The amount of Streptococcus mutans in saliva. Timepoint: Saliva samples are collected at the beginning and end of the intervention. Method of measurement: Bacteria are measured based on colony count. Esfahan University of Medical Sciences Approved 2021-10-12 Ethics committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Boulevard, Isfahan, Iran Isfahan Isfehan Iran (Islamic Republic of)