Comparative study of the effect of three mouthwashes Alphadent Daily, Vi-One General and Vi-One Chlorhexidine on the level of salivary Streptococcus Mutans
Determination of the effect of mouthwashes Alphadent Daily, Vi-One General and Chlorhexidine Vi-One on the level of salivary Streptococcus Mutans.
Determination of the average age in the studied groups.
Determination of the frequency distribution of gender in the studied groups.
Comparison of the level of salivary Streptococcus Mutans in three groups before and after the intervention.
Determination of the level of salivary Streptococcus Mutans in three group before and after the intervention.
Design
The number of 90 students of Sanandaj Dental School will be divided into 3 groups of 30 people by simple random method and using random blocks. The study will be conducted as a randomized, single-blind, phase 3 interventional study.
Settings and conduct
The place of intervention will be Sanandaj School of Dentistry. The one-sided blind intervention will be done by blinding the participants using unlabeled containers. Bacterial colony counting will be done in the microbiology laboratory of Sanandaj University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Students of Sanandaj Dental Faculty with informed consent to participate in the intervention.
Exit conditions:
Having dry mouth.
Use of orthodontic and prosthodontic appliances.
Any systemic disease such as diabetes.
Any oral soft tissue lesions.
Any composite restoration in the mouth.
Intervention groups
From all the participants , 1 ml of unstimulated saliva samples will be collected. The first group will receive Alfadent Daily mouthwash, the second group will receive Vi-One General mouthwash, and the third group will receive Vi-One Chlorhexidine mouthwash. All members will rinse the mouthwash for 60 seconds and remove it from the mouth every night after brushing. After fourteen days, saliva sampling will be done again.
Main outcome variables
reduction in salivary Streptococcus Mutans level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240219061051N1
Registration date:2024-03-02, 1402/12/12
Registration timing:registered_while_recruiting
Last update:2024-03-02, 1402/12/12
Update count:0
Registration date
2024-03-02, 1402/12/12
Registrant information
Name
Zahra Asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3366 8770
Email address
z1121377@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-28, 1402/12/09
Expected recruitment end date
2024-03-12, 1402/12/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of the effect of three mouthwashes Alphadent Daily, Vi-One General and Vi-One Chlorhexidine on the level of salivary Streptococcus Mutans
Public title
Assessment of the effect of mouthwashes Alphadent, Vi-One General and Chlorhexidine on salivary Streptococcus
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
To be the student of Sanandaj dentistry faculty.
To have informed consent to enter the intervention.
Exclusion criteria:
Having xerostomia.
Antibiotic therapy in the past month.
Any systemic diseases such as Diabetes..
Any compposite filling in oral cavity.
Using orthodontic or prosthodontic appliances.
Flouridetherapy in the past month.
Any oral soft tissue lesions.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The number of 90 students of Sanandaj Dental Faculty are divided into groups of 30 students in a simple random manner using random blocks.
Blinding (investigator's opinion)
Single blinded
Blinding description
In the single-blind intervention, mouthwashes in identical bottles without labels will be delivered to volunteers participating in the intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Approval date
2024-01-29, 1402/11/09
Ethics committee reference number
1402.203
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Level of Streptococcus Mutans in saliva according to the colony forming unit.
Timepoint
At the beginning of the intervention and 14 days later.
Method of measurement
Counting the number of colonies in a specific bacterial culture medium plate.
Secondary outcomes
1
Description
The level of Streptococcus mutans in saliva in terms of colony forming units.
Timepoint
At the beginning of the trial and 14 days later.
Method of measurement
Counting the bacterial colonies formed in the specific culture medium.
Intervention groups
1
Description
First Intervention group: Alfadent Daily mouthwash, containing the active ingredient Alpha-pinene, will be used once a day after brushing at night. Made by Alphadent company.
Category
Prevention
2
Description
Second Intervention group: Vi-One General mouthwash, containing the active ingredient cetylpyridinium chloride and sodium fluoride, will be used once a day after brushing at night. Made by Rojin company.
Category
Prevention
3
Description
third intervention group: Chlorhexidine Vi-One mouthwash, containing the active ingredient chlorhexidine 0.2%, will be used once a day after brushing at night. Made by Rojin company.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kurdistan University of Medical Sciences, Dentistry Faculty.
Full name of responsible person
Kavan Yaghmouri
Street address
Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3366 4645
Email
kavan_yaghmoori@yahoo.com
Web page address
https://www.muk.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Afshin Maleki
Street address
Pasdaran Blvd.
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3322 4645
Email
kavan_yaghmoori@yahoo.com
Web page address
https://www.muk.ac.ir
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
Zahra Asgari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Kurdistan university of medical sciences, Pasdaran Blvd, Sanandaj city
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3366 8770
Fax
Email
z1121377@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Zahra Asgari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Kurdistan university of medical sciences, Pasdaran Blvd, Sanandaj city
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3366 8770
Fax
Email
z1121377@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Sanandaj University of Medical Sciences
Full name of responsible person
Zahra Asgari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Kurdistan university of medical sciences, Pasdaran Blvd, Sanandaj city
City
Sanandaj
Province
Kurdistan
Postal code
66179-13446
Phone
+98 87 3366 8770
Fax
Email
z1121377@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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available