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IRCT20190410043228N2 IRCT 2021-02-08 Babol University of Medical Sciences The anti-bacterial effect on streptococcus mutans of chitosan mouth rinse The anti-bacterial effect on streptococcus mutans of chitosan mouth rinse in patients wearing orthodontic removable appliance 2020-07-05 anticipated 20 Complete https://irct.ir/trial/48989 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: Replacement blocks will be utilized for the purpose of randomization (the number of blocks based on the sample volume in the study). In this regard, "A" represents experimental group and “B” represents control group. Two individual outcomes AB and BA are possible. Moreover, it will be assumed that AB replaces even outcomes from the data table and BA replaces odd numbers. 3 The anti-bacterial effect on streptococcus mutans of chitosan mouth rinse. Intervention 1: Intervention group: Patients will learn oral hygiene instructions including brushing (modified Bass) and flossing the teeth. All patients were given time schedule for one month, in which they had to check it after each usage. All patients needed removable orthodontic appliances without expansion screw. A new removable orthodontic appliance was produced with Acroplus acrylic resin in the faculty laboratory a week after the healtheducation.The Chitosan with low (75%<DD<85%,MW 107 kDa) and high (75%<DD,MW 624 kDa) molecular weight which is produced by Sigma-Aldrich, St.Loius, USA was used for producing mouthwash. The mouthwash was produced with the 0.4% v/v dose and PH=5 of Chitosan. This compound consisted of 0.5% (W/V) NaCl salt, 1% (W/V) of Arabic gum stabilizer, and 5% (W/V) of Mannitol. After the complete solution, food flavor and oral dyes were added with a dose of 0.1% (V/V). The swab samples were made for the buccal area of upper right first molar. Each sample was placed inside a tube of 1 mL brain - heart infusion and then cultured in the Mitis salivarius agar medium. After 48h of incubation at 37℃, the Streptococcus mutans colonies were counted using the digital colony counter. Intervention 2: Control group: Patients will learn oral hygiene instructions including brushing (modified Bass) and flossing the teeth. All patients were given time schedule for one month, in which they had to check it after each usage. All patients needed removable orthodontic appliances without expansion screw. A new removable orthodontic appliance was produced with Acroplus acrylic resin in the faculty laboratory a week after the healtheducation. The mouthwash was produced with PH=5. This compound was consisted of 0.5% (W/V) NaCl salt, 1% (W/V) of Arabic gumstabilizer, and 5% (W/V) of Mannitol. After the complete solution, food flavor and oral dyes were added with the dose of 0.1% (V/V). Placebo mouthwashes were used (7 times in a week, each time for 20 seconds). The swab samples were made for Palatal area. Each sample was placed inside a tube of 1 mL brain - heartinfusion and then cultured in the Mitis salivarius agar medium. After 48h of incubation at 37℃,the Streptococcus mutans colonies were counted using the digital colony counter. Yes - There is a plan to make this available What will be shared: all data without recognizing participants in research When: 2020 year To whom: researchers Conditions: in future researches Where to obtain: published article How to obtain: referring to published article Comments:
public Mojan Madani
Alghadir str.
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3526 mojan.madani@hotmail.com Arak University of Medical Sciences scientific Mojan Madani
Alghadir str.
Arak Iran (Islamic Republic of) 3848176941 +98 86 3417 3526 mojan.madani@hotmail.com Arak University of Medical Sciences Iran (Islamic Republic of) wearing removable orthodontics appliance without expansion screw patients from 9 to 18 years old 9 years 18 years Both active caries and periodontal disease Suffering from a systemic disease antibiotic consumption in the last three months past fixed orthodontics or any kind of dental treatment during clinical study B95.4 Other streptococcus as the cause of diseases classified elsewhere Treatment - Drugs Placebo Intervention group: Patients will learn oral hygiene instructions including brushing (modified Bass) and flossing the teeth. All patients were given time schedule for one month, in which they had to check it after each usage. All patients needed removable orthodontic appliances without expansion screw. A new removable orthodontic appliance was produced with Acroplus acrylic resin in the faculty laboratory a week after the healtheducation.The Chitosan with low (75%<DD<85%,MW 107 kDa) and high (75%<DD,MW 624 kDa) molecular weight which is produced by Sigma-Aldrich, St.Loius, USA was used for producing mouthwash. The mouthwash was produced with the 0.4% v/v dose and PH=5 of Chitosan. This compound consisted of 0.5% (W/V) NaCl salt, 1% (W/V) of Arabic gum stabilizer, and 5% (W/V) of Mannitol. After the complete solution, food flavor and oral dyes were added with a dose of 0.1% (V/V). The swab samples were made for the buccal area of upper right first molar. Each sample was placed inside a tube of 1 mL brain - heart infusion and then cultured in the Mitis salivarius agar medium. After 48h of incubation at 37℃, the Streptococcus mutans colonies were counted using the digital colony counter Control group: Patients will learn oral hygiene instructions including brushing (modified Bass) and flossing the teeth. All patients were given time schedule for one month, in which they had to check it after each usage. All patients needed removable orthodontic appliances without expansion screw. A new removable orthodontic appliance was produced with Acroplus acrylic resin in the faculty laboratory a week after the healtheducation. The mouthwash was produced with PH=5. This compound was consisted of 0.5% (W/V) NaCl salt, 1% (W/V) of Arabic gumstabilizer, and 5% (W/V) of Mannitol. After the complete solution, food flavor and oral dyes were added with the dose of 0.1% (V/V). Placebo mouthwashes were used (7 times in a week, each time for 20 seconds). The swab samples were made for Palatal area. Each sample was placed inside a tube of 1 mL brain - heartinfusion and then cultured in the Mitis salivarius agar medium. After 48h of incubation at 37℃,the Streptococcus mutans colonies were counted using the digital colony counter. Counting of streptococcus mutans colonies. Timepoint: Before intervention, 1 month later. Method of measurement: using the digital colony counter. Babol University of Medical Sciences Approved 2019-06-09 Ethics Comittee of Babol University of Medical sciences Babol ِDentistry University, Ganj Afroz str. Babol Mazandaran Iran (Islamic Republic of)