Evaluation of the effects of Streptococcus salivarius M18 and K12 probiotic bacteria on the amount of Streptococcus mutans in saliva: a randomized clinical trial

The aim of this study was to evaluate the effect of short-term use of probiotics containing Streptococcus salivarius K12 and M18 bacteria on salivary Streptococcus mutans in order to evaluate their effectiveness in reducing tooth decay.

A randomized controlled clinical trial with a parallel group design of 40 patients. Block method and random allocation software were used for randomization.

The place of sampling and examination of people is in the School of Dentistry of Isfahan University of Medical Sciences. Saliva samples are taken from individuals before and after the intervention and cultured, and bacterial colonies are counted.

Entry requirements: people without orthodontic appliques or six months after the end of orthodontic treatment; people who have not taken antibiotics in the past month; people who do not have incomplete dental treatment; people without immune system diseases. No entry conditions: 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.

Probiotic products containing Salivarius M18 and K12 are claimed to be useful in preventing dental caries, however, little research is available to conclusively prove this. This study was designed to evaluate the efficacy of these probiotic substances. The control group in this study also took oral deodorant tablets with the same taste and consistency as the intervention group tablets.

The amount of Streptococcus mutans in saliva; the plaque index of individuals

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.

All our data except people names and phone numbers can be published

The data will be available 1 year after the results are published.

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.

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.

Dr. Firoozeh Nilchian Address: School of Dentistry, Isfahan University of Medical Sciences Phone: 00983137925594 Email: f_nilchian@dnt.mui.ac.ir Postal Code: 8174673461

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.