Using anti-bacterial effect of chitosan mouth rinse on streptococcus mutans in patients wearing orthodontic removable appliance
Design
Randomized, controlled, clinical trial
Settings and conduct
Babol Dentistry University
Participants/Inclusion and exclusion criteria
20 patients (10 females and 10 males) 9 to18 years old referring to Babol orthodontics department. None of patients suffer from active caries, periodontal and systematic disease. None of patients use antibiotics in the last three months . We exclude patients with past fixed orthodontic treatment and any kind of dental treatment during study.
Intervention groups
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 mouthwash which lacked the Chitosan was used as Placebo, containing the materials as mentioned above with the same pH, except Chitosan. 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
Main outcome variables
streptococcus mutans colonies on mitis salivarius agar medium
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190410043228N2
Registration date:2021-02-08, 1399/11/20
Registration timing:retrospective
Last update:2021-02-08, 1399/11/20
Update count:0
Registration date
2021-02-08, 1399/11/20
Registrant information
Name
mojan madani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3229 1408
Email address
m.madani@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-05, 1399/04/15
Expected recruitment end date
2020-08-05, 1399/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The anti-bacterial effect on streptococcus mutans of chitosan mouth rinse in patients wearing orthodontic removable appliance
Public title
The anti-bacterial effect on streptococcus mutans of chitosan mouth rinse
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
wearing removable orthodontics appliance without expansion screw
patients from 9 to 18 years old
Exclusion criteria:
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
Age
From 9 years old to 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee of Babol University of Medical sciences
Street address
Babol ِDentistry University, Ganj Afroz str.
City
Babol
Province
Mazandaran
Postal code
4774547176
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.MUBABOL.HRI.REC.1398.117
Health conditions studied
1
Description of health condition studied
The anti-bacterial effect on streptococcus mutans of chitosan mouth rinse
ICD-10 code
B95.4
ICD-10 code description
Other streptococcus as the cause of diseases classified elsewhere
Primary outcomes
1
Description
counting of streptococcus mutans colonies
Timepoint
Before intervention, 1 month later
Method of measurement
using the digital colony counter
Secondary outcomes
empty
Intervention groups
1
Description
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
Category
Treatment - Drugs
2
Description
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.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Babol Dentistry University
Full name of responsible person
Mojan Madani
Street address
Ganj Afroz str.
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 9592
Fax
+98 11 3219 0181
Email
mojan.madani@hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Hasan Alizade
Street address
Ganj Afroz str.
City
Babol
Province
Mazandaran
Postal code
4774547176
Phone
+98 11 3219 4647
Fax
+98 11 3219 0181
Email
mojan.madani@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojan Madani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Alghadir str.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Fax
+98 86 3417 3526
Email
mojan.madani@hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojan Madani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Alghadir str.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Fax
+98 86 3417 3526
Email
mojan.madani@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mojan Madani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Alghadir str.
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3526
Fax
+98 86 3417 3526
Email
mojan.madani@hotmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
all data without recognizing participants in research
When the data will become available and for how long
2020 year
To whom data/document is available
researchers
Under which criteria data/document could be used
in future researches
From where data/document is obtainable
published article
What processes are involved for a request to access data/document