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IRCT20210821052241N1 IRCT 2021-10-20 Esfahan University of Medical Sciences Clinical effects of Lactogum and ParsiLact-LA on oral health Evaluation of clinical effects of two probiotic products, Lactogum & ParsiLact-LA on oral health of patients treated with removable and fixed orthodontic appliances 2021-10-07 anticipated 60 Complete https://irct.ir/trial/58370 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 3 Oral health & periodontal status. Intervention 1: Intervention group 1: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a lozenge from Zist Takhmir company (Lactogum), which contains Streptococcus salivarius K12 and M12 with a concentration of 1000000000 CFU along with mint flavoring daily for 2 months. After 2 months those indices will be re-evaluated. Intervention 2: Intervention group 2: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a sachet from Pardis Roshd Mehrgan company (ParsiLact-/LA), which contains Lactobacillus acidophilus with a concentration of 2000000000 CFU along with Maltodextrin and Dextrose daily for 2 months. After 2 months those indices will be re-evaluated. Intervention 3: Control group 1: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a placebo lozenge from Zist Takhmir company, which are similar to the relevant probiotic in all respects daily for 2 months. After 2 months those indices will be re-evaluated. Intervention 4: Control group 2: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a placebo sachet from Pardis Roshd Mehrgan company, which are similar to the relevant probiotic in all respects daily for 2 months. After 2 months those indices will be re-evaluated. Yes - There is a plan to make this available What will be shared: It is possible to share study information after the patients became unidentifiable. When: 5 months after the results are published, the information will be available. To whom: Researchers related to academic services and scientific journals with sufficient credibility and probiotic products companies. Conditions: In order to use the results of the present study for similar studies or Production of probiotic products. Where to obtain: The respondent in this regard is Amin Ansarinia and applicants can contact him at the following address: ansar.ssu@gmail.com How to obtain: 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. Comments:
public Saeid Sadeghian
Isfahan School of Dentistry, Isfahan University of Medical Sciences, Hezar jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5543 sadeghian@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Amin Ansarinia
Isfahan School of Dentistry, Isfahan University of Medical Sciences, Hezar jerib street
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5543 ansar.ssu@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients planned for removable functional orthodontic appliances or full arch both jaws fixed orthodontic appliance therapy. Good general health. Good oral health (have a dental history that includes brushing at least once a day). Be willing and able to comply with the trial regime. To have normal tooth anatomy, oral mucosa and periodontal status. no limit no limit Both Inability to obtain informed consent. Presence of allergies, food sensitivities or food intolerance. Any congenital syndromes of the head and neck. Medical contraindications such as heart conditions or Gastrointestinal disorders. Any state or diseases necessitating taking immunosuppressants or antibiotics or any medication chronically prior to the procedures. Any special physical or mental needs that would compromise patient cooperation. History of surgery within the past year or planned to have a surgery in the next 90 days. Severe fever, nausea, vomiting, bloody Diarrhea or severe abdominal pain within the past 1 month. Chronic use of probiotics or food supplements of any kind and use of antibiotics, steroids, hormones, oral prophylaxis or anti-microbial mouth wash or tooth paste within 1 month before the start of the study. Use of products containing xylitol and fluoride or other anti cariogenic products. Poor compliance with oral hygiene regimens; poor periodontal health(presence of calculus and/or periodontal pocket); extensive dental restorations or uncontrolled caries activity. Pregnancy. Smoking. K05 Gingivitis and periodontal diseases Treatment - Drugs Treatment - Drugs Placebo Placebo Intervention group 1: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a lozenge from Zist Takhmir company (Lactogum), which contains Streptococcus salivarius K12 and M12 with a concentration of 1000000000 CFU along with mint flavoring daily for 2 months. After 2 months those indices will be re-evaluated. Intervention group 2: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a sachet from Pardis Roshd Mehrgan company (ParsiLact-/LA), which contains Lactobacillus acidophilus with a concentration of 2000000000 CFU along with Maltodextrin and Dextrose daily for 2 months. After 2 months those indices will be re-evaluated. Control group 1: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a placebo lozenge from Zist Takhmir company, which are similar to the relevant probiotic in all respects daily for 2 months. After 2 months those indices will be re-evaluated. Control group 2: Prior to the intervention, their PI, GI, BOP and saliva PH indices will be evaluated. Then they will take a placebo sachet from Pardis Roshd Mehrgan company, which are similar to the relevant probiotic in all respects daily for 2 months. After 2 months those indices will be re-evaluated. BOP index. Timepoint: BOP measurement before intervention and 2 months after use of probiotic /placebo. Method of measurement: The number of sites where bleeding is recorded is divided by the total number of available sites in the mouth and multiplied by 100 to express the bleeding index as a percentage. GI index. Timepoint: GI measurement before intervention and 2 months after use of probiotic/placebo. Method of measurement: Using the gingival index classification. PI index. Timepoint: PI measurement before intervention and 2 months after use of probiotic/placebo. Method of measurement: Using the plaque index classification. Saliva pH number. Timepoint: PH saliva measurement before intervention and 2 months after use of probiotic/placebo. Method of measurement: PH meter. Esfahan University of Medical Sciences Approved 2021-09-01 Ethics committee of Isfahan University of Medical Sciences Isfahan School of Dentistry, Isfahan University of Medical Sciences, Hezar jerib street Isfahan Isfehan Iran (Islamic Republic of)