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IRCT20210620051635N1 IRCT 2021-07-30 Tabriz University of Medical Sciences Antimicrobial efficacy of combination of chlorhexidine and nano-silver fluoride mouthwashes on orthodontic patients The antimicrobial efficacy of combination of chlorhexidine and nano-silver fluoride mouthwashes on Streptococcus mutans in orthodontic patients (Randomized clinical trial) 2021-06-21 anticipated 45 Complete https://irct.ir/trial/56988 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In order to assign patients to the study groups, permuted block randomization method was used with three patients in each block.The created list is as follows: ACB ABC BAC ABC BCA BAC CAB BCA CAB ACB ABC CBA CAB CBA ACB The results will be reported by mean ± standard deviation and frequency percentage. Shapiro-Wilk test will be used to analyze the normality of the data. In order to compare the amount of bacteria in the study groups, analysis of variance of covariance will be used. A probability of less than 5% will be considered a significant level. For data analysis, SPSS software version 20 will be used, Blinding description: This double-blind study is a randomized clinical study designed to evaluate the effectiveness of 3 mouthwashes and will be performed during 14 days in the orthodontic department of Tabriz Dental School. From the patients who refer to the orthodontic department, 45 people who meet the inclusion criteria will be selected and they will be asked to fill out the written consent form. Random allocation software will be used for randomization and allocation. Each eligible patient will be assigned to one of the three study groups, based on the list kept by the head of the faculty. Patients will receive their mouthwashes according to the letters of each block: A: Chlorhexidine B:Silver fluoride nano-particles C: Combined nano-silver fluoride and Chlorhexidine mouthwash ACB ABC BAC ABC BCA BAC CAB BCA CAB ACB ABC CBA CAB CBA ACB Patients will be randomly assigned to three groups. Group 1 (n = 15): Chlorhexidine mouthwash 0.2% Group 2 (n = 15): Silver fluoride nano-particles mouthwash 0.04% Group 3 (n = 15): Mouthwash containing a mixture of 0.1% chlorhexidine and silver fluoride nano-particles (400 ppm) For this purpose, mouthwash will be poured into similar plastic containers with the same size. The patient and the researcher will not be aware of the type of mouthwash. 2 dental caries in orthodontic patients. The first group (n = 15): Chlorhexidine mouthwash 0.2% , The second group (n = 15): Silver fluoride mouthwash 0.04% ,The third group (n = 15): Mouthwash containing 0.1% chlorhexidine mixture and silver fluoride nanoparticles (400 ppm) All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing.. Yes - There is a plan to make this available What will be shared: ---- When: 6 months after the results are published To whom: researchers of academic and scientific institutions Conditions: ----- Where to obtain: ---- How to obtain: ----- Comments:
public amir hooman sadr haghighi
15th floor, Azerbaijan Tower, 17 Shahrivar Jadid Ave Tabriz
tabriz Iran (Islamic Republic of) 0 +98 41 3557 2636 Hooman_sadr7@yahoo.com Tabriz University of Medical Sciences scientific amir hooman sadr haghighi
15th floor, Azerbaijan Tower, 17 Shahrivar Jadid Ave Tabriz
tabriz Iran (Islamic Republic of) 0 +98 41 3557 2636 Hooman_sadr7@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients not receiving antibiotic therapy for the past three weeks Patients not receiving fluoride therapy for the past three weeks patients agreed with the informed written consent previous to the study Patients in the 20-40 age range 20 years 40 years Both Patients with dental prostheses (crown and bridge) Patients with soft tissue pathology Patients with poor oral health (DMFT> 8) Smokers Patients with orthodontic removable appliances Prevention The first group (n = 15): Chlorhexidine mouthwash 0.2% , The second group (n = 15): Silver fluoride mouthwash 0.04% ,The third group (n = 15): Mouthwash containing 0.1% chlorhexidine mixture and silver fluoride nanoparticles (400 ppm) All patients will be asked to brush their teeth with regular toothpaste twice a day for 2-4 minutes and to rinse their mouth with 10 ml of mouthwash twice a day for 30 seconds and not to eat or drink anything for half an hour after that.The best time to use mouthwashes is before bed and after brushing. Time،The amount of bacteria،Studied groups. Timepoint: Before intervention - 14 days after the intervention (Using Mouthwash). Method of measurement: Time: 2 times (before and after using mouthwash (first day and 14th)) Bacterial content: Colony counting unit study groups: Chlorhexidine, silver fluoride, combination of Chlorhexidine and silver fluoride. Time, The amount of bacteria, Study groups. Timepoint: 2 times (before intervention and 14 days after intervention). Method of measurement: Time: 2 times (before intervention _ 14 days after intervention) Bacterial content: colony-forming unit Study groups: 2 times (before intervention _14 days after intervention). Tabriz University of Medical Sciences Approved 2021-05-22 Ethics committee of Tabriz University of Medical Sciences no10، narges alley، baghe esmail agha ave، tohid blvd mahabad West Azarbaijan Iran (Islamic Republic of)