Evaluation the effect of distilled water, chlorhexidine mouthwash and ethanolic extract of Peganum Harmala plant on the count of Streptococcus mutans settled on removable orthodontic appliances
Evaluation the effect of distilled water, chlorhexidine mouthwash and ethanolic extract of Peganum Harmala plant on the count of Streptococcus mutans settled on removable orthodontic appliances
Design
A clinical trial with control group ,with a single design ,without blinding ,non-randomized ,phase 1-2 , on 30 patients
Settings and conduct
The number of 30 patients referred to the orthodontic department of the clinic of the dental school of Ilam province is selected. Due to the difference in the microbial flora of the people's mouths, the comparison between the amount of flora obtained from each person's test and his own. During 10-day cycles, 3 containers are given to the patients to place the orthodontic plaques inside when they are removed from the mouth. At the end, the flora obtained from each of these three containers will be compared with that person's own container. We will compare container 1, 2 and 3 for each person) and then make a general conclusion. - Method of work in order: entry of patients into the study, obtaining informed consent, molding and preparation of retainer, sampling and determination of MIC and MBC of herbal extract, delivery of orthodontic plate and dishes to patients in 10-day periods respectively - analysis
Participants/Inclusion and exclusion criteria
entering the study:prescription of orthodontic retainer by a specialist - age 20-60 years
not entering the study: active periodontal disease - History of using chlorhexidine mouthwash during the last two weeks
Intervention groups
Intervention1(Chlorhexidine mouthwash)-Intervention2(Ethanol extract of Paganum harmala plant)
Main outcome variables
the count of Streptococcus mutans settled on removable orthodontic appliances .
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221030056345N1
Registration date:2023-07-16, 1402/04/25
Registration timing:registered_while_recruiting
Last update:2023-07-16, 1402/04/25
Update count:0
Registration date
2023-07-16, 1402/04/25
Registrant information
Name
Fatemeh Jafarzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3385 3746
Email address
doctorfj1999@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2023-08-06, 1402/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of distilled water, chlorhexidine mouthwash and ethanolic extract of Peganum Harmala plant on the count of Streptococcus mutans settled on removable orthodontic appliances
Public title
Evaluation the effect of distilled water, chlorhexidine mouthwash and ethanolic extract of Peganum Harmala plant on the count of Streptococcus mutans settled on removable orthodontic appliances
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Consent of participants to participate in the study
Retainer prescription by an orthodontic specialist
Age 20-60 years
Exclusion criteria:
Active periodontal disease
History of using chlorhexidine mouthwash during the last two weeks
Age
From 20 years old to 60 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research ethics committees of ilam university of medical sciences
Street address
Pardis of Ilam University of Medical Sciences ,Paghoohesh Blvd,Banganjab,Ilam
City
Ilam
Province
Ilam
Postal code
6939177143
Approval date
2023-06-17, 1402/03/27
Ethics committee reference number
IR.MEDILAM.REC.1402.038
Health conditions studied
1
Description of health condition studied
the count of Streptococcus mutans settled on removable orthodontic appliances
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
count of Streptococcus mutans settled on removable orthodontic appliances
Timepoint
10 days after the intervention
Method of measurement
Through microbial culture and colony counting
Secondary outcomes
empty
Intervention groups
1
Description
Control: Distilled water-ph=6.5-7.5-TDS=0.00ppm-CL=0.00-once for 30 participants in a 10-day period-after removing the movable orthodontic plate from the mouth, the participant will immerse it in a container containing distilled water. and to put it back in the mouth, he will use tweezers to remove the mobile plaque from distilled water. After 10 days, the solution will be cultured - Sina Noor Company
Category
N/A
2
Description
First Intervention: The first intervention group: Chlorhexidine 0.2% - mouthwash - every 100 ml containing: chlorhexidine gluconate 0.2 g + 10% ethanol - Najo company - the participant for 10 days after removing the removable orthodontic plate from the mouth, put it in a container containing Chlorhexidine mouthwash will be immersed and forceps will be used to remove the mobile plaque from the mouthwash to put it back in the mouth. After 10 days, the solution will be cultured.
Category
Treatment - Drugs
3
Description
Second Intervention: Ethanol extract of pecan plant-combination: 600 grams of pecan is prepared for the preparation of herbal mouthwash. After washing and drying, the fruit and seeds of the plant will be separated and ground with a grinder. The resulting powder is poured into a container and Its surface is completely covered with 96% ethanol and it remains in this state for 48 hours. Then the resulting mixture is placed in the oven. After 72 hours, when the solution remains in the oven, the solution is removed from the machine and passed through filter paper. Then the resulting solution is placed in the rotary device little by little and several times. And in this way, the alcohol is separated from the solution and a liquid is obtained, which after drying will be the same pecan plant extract that is used to prepare Different concentrations will be dissolved in normal saline serum.-The concentration used in the study will be lower than MTT (the highest value obtained from MIC determination) - the participant will immerse the movable orthodontic plate in a container containing pecan plant mouthwash for 10 days after removing it from the mouth. Placing it back in the mouth will use forceps to remove the moving plaque from the solution. After 10 days, the solution will be cultured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Facuity of dentistry, ilam university of medical scienes,Ilam,Iran
Full name of responsible person
Parisa Kazemi
Street address
Faculty of Dentistry (old Parsian building)-pardis2-the end of the paghoohesh Blvd-Bangjnab-Ilam
City
ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3223 8499
Fax
Email
kazemip222@gmail.com
Web page address
https://dentistry.medilam.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Sobhan ghafurian
Street address
Paghoohesh Blvd
City
Ilam
Province
Ilam
Postal code
6939177143
Phone
+98 84 3222 7134
Email
info@medilam.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
ilam university of medical sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Fatemeh Jafarzadeh
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Amirkabir
City
Ilam
Province
Ilam
Postal code
6931836116
Phone
+98 84 3385 3746
Fax
Email
doctorfj99@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Fatemeh Jafarzadeh
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Amirkabir
City
Ilam
Province
Ilam
Postal code
6931836116
Phone
+98 84 3385 3746
Fax
Email
doctorfj99@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ilam University of Medical Sciences
Full name of responsible person
Fatemeh Jafarzadeh
Position
dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Amirkabir
City
Ilam
Province
Ilam
Postal code
۶۹۳۱۸۳۱۱۶
Phone
+98 84 3385 3746
Email
doctorfj1999@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Without mentioning the name of the participants, the amount of MIC and MBC of the plant extract and cfu obtained from the three materials used will be shared.
When the data will become available and for how long
The access period will start 1 year after the results are published
To whom data/document is available
The data will be accessible to researchers working in academic and scientific institutions and students interested in research
Under which criteria data/document could be used
Data access is allowed if researchers use them to increase awareness and interest in conducting further studies
From where data/document is obtainable
Email address: doctorfj1999@yahoo.com
What processes are involved for a request to access data/document
Applicants should include researchers working in academic and scientific institutions or students who, after sending the documents to the email address doctorfj1999@yahoo.com and mentioning the purpose of the data study, the result will be sent to them via email within 2-3 months at most. becomes