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IRCT20220504054736N1 IRCT 2022-11-30 Ahvaz University of Medical Sciences Effect of post-biotic on the number of Streptococcus Mutans in patients undergoing fixed orthodontic treatment. Comparison of the effect of daily use of mouthwash and toothpaste containing post-biotic on the number of Streptococcus Mutans in the saliva of patients undergoing fixed orthodontic treatment. 2022-12-22 anticipated 60 Complete https://irct.ir/trial/63355 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization: For this purpose, after creating a computer-generated random sequence using Winpepi software, equal blocks of 6 will be used. unit of randomization is individual and randomization tool is sealed envelopes. These steps are performed by an independent statistician who is also responsible for transferring the envelopes containing the treatment code to the pharmacist in charge of the making of the treatment and placebo products, Blinding description: When entering the study, each of the participants will be given a number, which is transferred to the pharmacist in charge of the making of the treatment and placebo products. The participants, the person evaluating the results of the intervention and the data analyst will not know the type of treatment of the people. Therapeutic products and placebo are packed in exactly the same opaque sealed bags, there is no difference in terms of color, smell and taste, and the label does not specify the nature of the treatment or placebo. 3 Dental caries. Intervention 1: Intervention group: participants in this group brush their teeth twice a day for 4 weeks, using toothpaste containing post-biotic Bifidobacterium animalis subsp. animalis with a concentration of 2*10^ 9. Intervention 2: Intervention group: participants in this group wash their mouths daily for 4 weeks, using a mouthwash containing post-biotic Bifidobacterium animalis subsp. animalis with a concentration of 2*10^ 9. Intervention 3: Control group: Participants in this group use mouthwash and toothpaste similar to the intervention groups daily for 4 weeks. The only difference between toothpaste and mouthwash used by this group will be the absence of post-biotic. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Minoo sadat Alavi
Orthodontics Departman, Faculity Of Dentistry, Ahvaz Jundishapur University of Medical Sciences, Valiasr Blv, Golestan Town
Ahvaz Iran (Islamic Republic of) 6135715775 +98 61 3311 2785 minooalavi116@gmail.com Ahvaz University of Medical Sciences scientific Minoo sadat Alavi
Orthodontics Departman, Faculity Of Dentistry, Ahvaz Jundishapur University of Medical Sciences, Valiasr Blv, Golestan Town,
Ahvaz Iran (Islamic Republic of) 6135715775 +98 61 3311 2785 minooalavi116@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Good oral hygiene Good general health Permanent dentition DMF (decay, missing, filling)<5 12 years and older 12 years no limit Both Use of anti-inflammatory drugs or antibiotics in the last month and during orthodontic treatment Use of products containing Xylitol, Fluoride, Chlorhexidine and probiotics or post-biotics K02 Dental caries Prevention Prevention Placebo Intervention group: participants in this group brush their teeth twice a day for 4 weeks, using toothpaste containing post-biotic Bifidobacterium animalis subsp. animalis with a concentration of 2*10^ 9. Intervention group: participants in this group wash their mouths daily for 4 weeks, using a mouthwash containing post-biotic Bifidobacterium animalis subsp. animalis with a concentration of 2*10^ 9. Control group: Participants in this group use mouthwash and toothpaste similar to the intervention groups daily for 4 weeks. The only difference between toothpaste and mouthwash used by this group will be the absence of post-biotic. Number of Streptococcus mutans in saliva. Timepoint: before intervention, 4 and 8 weeks after intervention. Method of measurement: Saliva collection and Streptococcus mutans count. Ahvaz University of Medical Sciences Approved 2022-11-11 Ethics committee of Ahvaz University of Medical Sciences Deputy of research and technology, Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd Ahvaz Khouzestan Iran (Islamic Republic of)