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IRCT20181121041713N4 IRCT 2021-10-12 Shiraz University of Medical Sciences Effect of fluoride and xylitol varnish on oral microorganism The effect of combination of xylitol and fluoride varnish on microbial biofilm and saliva in fixed orthodontic patients: a randomized clinical trial 2021-10-11 anticipated 120 Complete https://irct.ir/trial/58543 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Block randomization method will be used with block size of 8, using online software (RANDOM.ORG) to allocate patients to four experimental groups with a 1:1:1:1 ratio. Following the random sequence generation, random numbers will be allocated to each patient in sealed opaque envelopes. Before the varnish application, the envelope will be opened to disclose the assigned treatment, Blinding description: All varnishs will be spilled into identical tubes that will be color coded by the first investigator, so the clinician who assigns the intervention, the patients, laboratory technician, and the statistician will be all blind to the treatment groups. 3 Cariogenic bacteria in the oral cavity. Intervention 1: Intervention group: first/fluoride varnish/sodium fluoride 5 percentage(Product of Asia Chemi Teb Pharmaceutical Company) / two drops of varnish/fluoride varnish is applied to the teeth at the beginning of intervention and 30 days later. Intervention 2: Intervention group: second/xylitol varnish/xylitol 10 percentage(Product of Asia Chemi Teb Pharmaceutical Company)/two drops of varnish/xylitol varnish is applied to the teeth at the beginning of intervention and 30 days later. Intervention 3: Intervention group: third/combination of xylitol varnish and fluoride varnish /xylitol 10 percentage+ fluoride 5 percentage(Product of Asia Chemi Teb Pharmaceutical Company)/two drops of varnish/xylitol varnish is applied to the teeth at the beginning of intervention and 30 days later. Intervention 4: Control group: placebo varnish/ simple varnish with out fluoride and xylitol (Product of Asia Chemi Teb Pharmaceutical Company)/two drops of varnish/ varnish is applied to the teeth at the beginning of intervention and 30 days later. 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 not applicable
public Dr.Neda Babanouri
Qasrodasht Ave , Mehr Blvd
Shiraz Iran (Islamic Republic of) 7195616878 +98 71 3628 0801 nedababanouri@yahoo.com Shiraz University of Medical Sciences scientific Dr. Neda Babanouri
Qasrodasht Ave, Mehr Blvd
Shiraz Iran (Islamic Republic of) 7195615878 +98 71 3628 0801 babanouri@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Age between 12 and 30 years old Permanent dentition Good general health No anti-inflammatory or antibiotic medications taken in the month before the study No chewing gum or mouthwash use in the last week and during the study Brushing twice daily with fluoride toothpaste No active or untreated caries lesions or gingival inflammation 12 years 30 years Both Treatment with antibiotics, steroids or any medication known to cause dry mouth in the last 3 months Poor oral hygiene Active periodontal disease Sever crowding of anterior teeth that would be likely to interfere with cleaning of tooth surface Smoking History of mouth breathing Prevention Prevention Prevention Placebo Intervention group: first/fluoride varnish/sodium fluoride 5 percentage(Product of Asia Chemi Teb Pharmaceutical Company) / two drops of varnish/fluoride varnish is applied to the teeth at the beginning of intervention and 30 days later. Intervention group: second/xylitol varnish/xylitol 10 percentage(Product of Asia Chemi Teb Pharmaceutical Company)/two drops of varnish/xylitol varnish is applied to the teeth at the beginning of intervention and 30 days later. Intervention group: third/combination of xylitol varnish and fluoride varnish /xylitol 10 percentage+ fluoride 5 percentage(Product of Asia Chemi Teb Pharmaceutical Company)/two drops of varnish/xylitol varnish is applied to the teeth at the beginning of intervention and 30 days later. Control group: placebo varnish/ simple varnish with out fluoride and xylitol (Product of Asia Chemi Teb Pharmaceutical Company)/two drops of varnish/ varnish is applied to the teeth at the beginning of intervention and 30 days later. Number of bacterial colonies. Timepoint: Before beginning the intervention and 45 days later. Method of measurement: Counting the number of bacterial colonies. . Timepoint: . Method of measurement: . Shiraz University of Medical Sciences Approved 2021-07-14 Ethics Committee of Shiraz University of Medical Sciences Qasrodasht Ave, Mehr Blvd Shiraz Fars Iran (Islamic Republic of)