Evaluation of clinical effects of two probiotic products, Lactogum & ParsiLact-LA on oral health of patients treated with removable and fixed orthodontic appliances

Evaluation and comparison of clinical effects of two probiotic products, Lactogum & ParsiLact-LA on oral health of orthodontic patients

A controlled randomized clinical trial, double blind, parallel group design of 60 patients. Block randomization will be performed by random number table.

The study will be conducted at Isfahan Dental School. 60 orthodontic patients will randomly be divided into 2 intervention groups and 2 control groups and effects of probiotic consumption on BOP, GI, PI and PH saliva will be evaluated. In the present study, research team members and statistical analyzer will be blinded, by coding system.

Inclusion criteria: patients treated with removable and fixed orthodontic appliances of both jaws. Exclusion criteria: any Physical, mental, physiologic & anatomic conditions preventing the intervention.

In the present study, there are four intervention groups. Two groups will receive probiotics (group A: Lactogum which contains Streptococcus salivarius & group B: ParsiLact-LA which contains Lactobacillus acidophilus) and two groups will receive placebo (which are similar to probiotics in all respects).

The score of BOP, GI, PI and PH saliva

In the present study, block randomization with a 1: 1 allocation ratio using a random number table and by someone outside the research team will be used. For this purpose we will have 6 blocks (ABC - ACB - BAC - BCA - CAB - CBA). Each block will be randomly assigned a number from 1 to 6. After that, we will select the starting point in the randomization table with closed eyes, and then move on to the same row or column, and numbers that are less than or equal to 6; Are selected to reach the desired sample size of 60 (three groups of 20 people). In the present study, if we call the control group C; Later, control group patients can be divided into two groups using double blocks to form two control groups (C1 and C2). Allocation will be concealed using identical, sealed, opaque envelopes which will be ordered by number by someone outside the research team. To do this, patients' names will be coded and a list of these codes (with no other patients' demographic information) will be sent to the person outside the research team. So, the assignor person will identify each patient with a only by the allocated code.

In the present study, members of the study team and statistical analyzer will be blinded (double blind). Description: First, demographic information and study variables will be taken from all patients. Then, this information will be sent to the statistical analyzer after being coded (each code represents a patient). The statistician will randomly classify the patients into intervention and control groups, without knowing that each code belongs to which patient. After assigning each code to the intervention or control groups, the information will be transferred by the statistician to a person outside the study team. This person will place the probiotic or placebo in opaque, identical and sealed envelopes according to the patients' codes (therefore, blinding will be performed on him as well) ,and then the envelopes will be delivered to the research team members. Research team members will not have any information about the contents of each envelope (probiotic or placebo) or the information exchanged between the statistician and that person outside the research team (assigning probiotic or placebo to each code). They will deliver the envelope belonged to each patient to that patient (code) (the envelopes will be arranged in numbers, with the number of each code representing each specific patient). Patients are then asked to consume the substance in the envelope according to the instructions in their envelope. In order to measure variables, a member of the research team will measure the variables, without knowing how patients are assigned to the study groups. Then he will report the information without reporting the patient's name (using another code) to the statistician, who will analyze the results without knowing each code belongs to which intervention group.

It is possible to share study information after the patients became unidentifiable.

5 months after the results are published, the information will be available.

Researchers related to academic services and scientific journals with sufficient credibility and probiotic products companies.

In order to use the results of the present study for similar studies or Production of probiotic products.

The respondent in this regard is Amin Ansarinia and applicants can contact him at the following address: ansar.ssu@gmail.com

The applicant can send his request to the mentioned email address and if his eligibility for access to the information is confirmed, he will receive them within two weeks.