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IRCT20200203046363N1 IRCT 2020-03-02 Mashhad University of Medical Sciences The effectiveness of probiotics pills on microbial population in orthodontic patient A clinical trial to compare the effectiveness of probiotics pills with fluoride mouthwash on microbial population in saliva in fixed orthodontic patients 2020-04-20 anticipated 75 Complete https://irct.ir/trial/45785 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: The subjects will be randomly assigned into three groups of 25 patients with blocks of 2, 4, and 6 using randomization method. A noninvolved researcher will determine the random assignment sequencing in sampling using a statistical analysis system (SAS), computer software. Sequentially numbered sealed opaque envelopes will be used to conceal the sequencing. Accordingly, the participants were given codes and assigned into the intervention and two control groups, Blinding description: Patients whose undergoing orthodontic treatment and referring to Dental Clinic of Mashhad Faculty of Dentistry, are chosen as the participants of the study. In this double-blind study, sealed opaque envelopes will be used to conceal the sequencing. The person responsible for data collection and clinical care are blind to group allocation and the type of drugs. 2-3 Orthodontic. Intervention 1: The intervention group will receive Lacto Gum biodegradable sucker pills containing Lactobacillus salivarius produced by Biology Fermentation Company for 3 weeks. Intervention 2: Control group one will receive sucker pills of placebo without Lactobacillus salivarius produced by Biology Fermentation Company for 3 weeks. Intervention 3: Control group two will receive fluoride mouthwash for 3 weeks. Yes - There is a plan to make this available What will be shared: Information on the main outcome or the like can be shared. When: 6 months after printing results To whom: Our data will only be available to researchers working at science centers and universities. Conditions: Our data will be available for scholars working at science centers and universities. Where to obtain: Amirreza Faraji Eraghi provides the data analysis to the applicants via email: farajiar931@mums.ac.ir How to obtain: Applicants can respond to the email of the respondent and receive a response within a week. Comments:
public Amirreza Faraji Eraghi
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3884 1674 farajiar931@mums.ac.ir Mashhad University of Medical Sciences scientific Amirreza Faraji Eraghi
Dental Clinic of Mashhad Faculty of Dentistry, Opposite Mellat Park, Vakilabad Blvd
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3884 1674 farajiar931@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age of 17-18 years No history of systemic disease Nonuse of antibiotic and probiotic drugs The patient is in the middle of the spectrum regarding caries risk, and not high caries risk is recommended. In addition, the individual should have good oral hygiene 14 years 18 years Both Dentinogenesis imperfect Amelogenesis imperfect Having specific metabolic diseases Bulimia nervosa Anorexia nervosa Having probiotics drug intolerance Z46.5 Fitting and adjustment of ileostomy and other intestinal appliances Prevention Prevention Prevention The intervention group will receive Lacto Gum biodegradable sucker pills containing Lactobacillus salivarius produced by Biology Fermentation Company for 3 weeks. Control group one will receive sucker pills of placebo without Lactobacillus salivarius produced by Biology Fermentation Company for 3 weeks. Control group two will receive fluoride mouthwash for 3 weeks. Buffering power of the saliva. Timepoint: Before and 3 weeks after the intervention. Method of measurement: PH meter device. Streptococcus mutans population. Timepoint: Before and 3 weeks after the intervention. Method of measurement: Microbial counting. Lactobacillus population. Timepoint: Before and 3 weeks after the intervention. Method of measurement: Microbial counting. Mashhad University of Medical Sciences Approved 2020-01-01 Ethics Committee of Mashhad University of Medical Sciences Vice Chancellor for Research, Mashhad University of Medical Sciences, Ghoreishi building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)