Comparative study of effect of three mouthwashes Listerine, Irsha, and Vi one general on the salivary streptococcus mutans level.
Design
Clinical trial, single blind and with parallel groups
Settings and conduct
School of Dentistry, Kurdistan University of Medical Sciences
Participants/Inclusion and exclusion criteria
Clinical samples are selected from dental students of Kurdistan University of Medical Sciences.
Inclusion criteria: informed consent of participants
Exclusion criteria:
Taking antibiotics in the last month
- Performed fluoride therapy in the last month
Existence of orthodontic appliques
Existence of diseases with suppressed immune system and diabetes
Presence of oral soft tissue lesions such as irritated fibroids, PGCG, papilloma
Intervention groups
1- listerine mouthwash, COOL MINT model
2. Vi one General mouthwash without alcohol
3- Irsha Anti-Plaque Mouthwash
Main outcome variables
Reduction of salivary streptococcus mutans
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161019030377N1
Registration date:2021-12-18, 1400/09/27
Registration timing:registered_while_recruiting
Last update:2021-12-18, 1400/09/27
Update count:0
Registration date
2021-12-18, 1400/09/27
Registrant information
Name
Seyyedeh Pouya Morovati
Name of organization / entity
kurdistan university of medical sciences,school of dentistry
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 9507
Email address
morovati.p@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2021-12-22, 1400/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of effect of three mouthwashes Listerine, Irsha, and Vi one general on the salivary streptococcus mutans level.
Public title
Comparative study of effect of three mouthwashes Listerine, Irsha, and Vi one general on the salivary streptococcus mutans level.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Dental Students of Kurdistan University of Medical Sciences
Informed Consent
Exclusion criteria:
antibiotic consumption within recent month
fluoride therapy within recent month
orthodontic appliance
immune- compromised condition like Diabetic patients
soft tissue oral pathology like PGCG etc.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The names of all the people who are eligible to enter the research (180 people) are written on separate cards and all are placed in a container, then the people who are drawn out one by one, The research samples (90 people) are randomly divided into three groups of one, two and three. They are written with the letter A, another third with the letter B, and the other third with the letter C, and people are grouped into one, two, or three based on the letter of the selected card.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study will be single blinded and all mouthwashes are prepared into opaque bottles of the same volume without any specifications
Placebo
Not used
Assignment
Parallel
Other design features
For the first time, the clinical efficacy of Vi One mouthwash in relation to other mouthwashes in reducing salivary streptococcus mutans is being evaluated.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Approval date
2021-01-11, 1399/10/22
Ethics committee reference number
IR.MUK.REC.1399.264
Health conditions studied
1
Description of health condition studied
salivary streptococcus mutans
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Reduction of salivary streptococcus mutans
Timepoint
2weeks
Method of measurement
Samples are asked to use mouthwash once a day for 2 weeks and after consuming mouthwash for at least 30 minutes to refrain from consuming any food and beverages as well as mouth washing. Saliva samples are taken from all participants before and after mouthwash. The sampling method is to ask them to rinse their mouths with saline before eating breakfast and brushing their teeth. Then 1 cc of non-stimulating saliva is collected by spitting in a sterile tube and immediately sent to the laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Listeine mouthwash:Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).
Category
Prevention
2
Description
Intervention group: Vi One general mouthwash :Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).
Category
Prevention
3
Description
Intervention group: Irsha mouthwash:Samples are asked to use this mouthwash once a day for 2 weeks and after using the mouthwash, avoid consuming any food and drink for at least 30 minutes and also to rinse the mouth. Before and after using the mouthwash, saliva sampling is performed from all participants. In this way,They are asked to rinse their mouths with saline before eating breakfast and brushing their teeth, and to rinse their contents after rinsing. 1 cc of their non-stimulated saliva is then collected by spitting into a sterile tube and immediately sent to a laboratory for microbial culture and measurement of Streptococcus mutans (CFU / ml).
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
dental school ,Kurdistan university of medical sciences
Full name of responsible person
Seyyedeh Pouya Morovati
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 8770
Email
pouyamorovati@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Dr Afshin Maleki
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
6617713446
Phone
+98 87 3366 8770
Email
Pouyamorovati@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sanandaj 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
Sanandaj University of Medical Sciences
Full name of responsible person
Seyyedeh Pouya Morovati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
66177713446
Phone
+98 87 3366 8770
Email
pouyamorovati@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Seyyedeh Pouya Morovati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
66177713446
Phone
+98 87 3366 8770
Email
pouyamorovati@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Seyyedeh Pouya Morovati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Street
City
Sanandaj
Province
Kurdistan
Postal code
66177713446
Phone
+98 87 3366 8770
Email
pouyamorovati@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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