Comparing the effect of chlorhexidine mouthwash with kefir drink on clinical indicators of gingivitis.
Design
A clinical trial with a control group with parallel groups, without the possibility of blinding, randomized by the random blocks, on 40 patients, random allocation software 2 will be used for randomization.
Settings and conduct
The location of the Periodontology Department of Mazandaran Dental School, explaining all the treatment steps and obtaining a written statement from the patients, measuring clinical parameters including PI, GI and SBI by a final year dental student on Ramfjord teeth, complete scaling and health education, division Classification into two test and control groups, delivery of mouthwashes to the patient, recording of indicators at the beginning of the study and at the end of the first and third week.
Participants/Inclusion and exclusion criteria
Entry requirements: People must have appropriate cooperation.
People with plaque-related gingivitis;
People with systemic disease, corticosteroid users and smokers.
People with a history of antibiotic treatment in the last 3 months
Intervention groups
In this study, we will have two intervention groups.
One group was given 5 ml of chlorhexidine mouthwash per day for 21 days, and the other group was given 100 ml of kefir mouthwash for 21 days.
Main outcome variables
PI index, GI index, SBI index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200905048620N2
Registration date:2024-02-09, 1402/11/20
Registration timing:registered_while_recruiting
Last update:2024-02-09, 1402/11/20
Update count:0
Registration date
2024-02-09, 1402/11/20
Registrant information
Name
Leila Jabbareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3325 4134
Email address
l.jabbareh@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-08, 1402/11/19
Expected recruitment end date
2024-05-08, 1403/02/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of chlorhexidine mouthwash with kefir drink on clinical indices of gingivitis
Public title
Investigating the effect of kefir drink on gingivitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who have appropriate cooperation
Patients with at least 20 functioning teeth
Patients with plaque-related gingivitis
Exclusion criteria:
People with systemic diseases
People using corticosteroids and smoking
People who are allergic to mouthwash
Poorly cooperative people
People have orthodontics and prostheses
Pregnant people
People with a history of antibiotic treatment or taking anti-inflammatory drugs in the last 3 months
People with mouth breathing habit
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Using random allocation software 2, patients are distributed into two control and intervention groups using the randomized block method (blocks of 4).
The numbers of each block are placed in sealed envelopes.
Then, according to the order of people's visits, an envelope is opened randomly and numbers are assigned to people.
People with even numbers are assigned to the intervention group and people with odd numbers are assigned to the control group.
This process is repeated until the last sample is selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mazandaran University of Medical Sciences
Street address
Research Vice-Chancellor ., University Building No. 2., Moalem Square.,
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2024-01-09, 1402/10/19
Ethics committee reference number
IR.MAZUMS.REC.1402.551
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.10
ICD-10 code description
Chronic gingivitis, plaque induced
Primary outcomes
1
Description
dental plaque index
Timepoint
At the beginning of the study (before using mouthwashes) and 7 and 21 days after starting to use mouthwashes
Method of measurement
Observing and recording the plaque index of each tooth according to the Loe & Silness scale table
Secondary outcomes
1
Description
gingival index
Timepoint
At the beginning of the study (before using mouthwashes) and 7, 21 days after starting to use mouthwashes
Method of measurement
Examination and recording of gingival index for each tooth according to Loe & Silness scale table for gingival index
2
Description
gingival sulcus bleeding index
Timepoint
At the beginning of the study (before using mouthwashes) and 7, 21 days after starting to use mouthwashes
Method of measurement
Examination and recording of gingival bleeding for each tooth by periodontal probe and Muhlemann & Son table
Intervention groups
1
Description
Intervention group: This group will be given 100 ml of kefir drink for 21 days. In this study, homemade kefir drink will be used (after boiling 1.5% fat milk of Pegah Dairy Company of Iran and cooling it at room temperature, kefir grains will be It will be added, fermentation will be done at 48°C for 48 hours and then the kefir grains will be separated by filtering) and the patients will be taught to rinse their mouth twice a day for one minute for 3 weeks. Gargle the given. They will also be told to refrain from eating and drinking for half an hour and from consuming other probiotic products during the treatment period.
Category
Prevention
2
Description
Control group: This group will be given 0.2% chlorhexidine mouthwash made by Iran Najo Company in the amount of 5 ml per day for 21 days. Patients will be instructed to gargle the given mouthwash for one minute twice a day for 3 weeks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Touba Dental Clinic
Full name of responsible person
Dr.Leila Jabareh
Street address
Touba Dental Clinic, Khazar Boulevard, Sari
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3329 1895
Email
l.jabbareh@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.pedram Ebrahim nejad
Street address
Touba Dental Clinic., Khazar Boulevard.
City
Sari
Province
Mazandaran
Postal code
4816895475
Phone
+98 11 3329 1895
Email
l.jabbareh@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Leila Jabbareh
Position
PhD in periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Sari Dental clinic., next to Touba .,Caspian Square
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3329 1895
Email
l.jabbareh@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Leila Jabareh
Position
PhD in periodontics
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Sari Dental Clinic., next to Touba ., Caspian Square
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3329 1895
Email
l.jabbareh@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Leila Jabareh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Sari Dental Clinic., next to Touba., Caspian Square,
City
Sari
Province
Mazandaran
Postal code
33971-48157
Phone
+98 11 3329 1895
Email
l.jabbareh@mazums.ac.ir
Web page address
https://www.mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Title and more details about the data/document
After finishing the project, the results will be delivered in the form of a final report and electronically (on a CD) to the Research Vice-Chancellor and Faculty of Dentistry of Mazandaran University of Medical Sciences.
When the data will become available and for how long
The decision regarding the access to the data will be the responsibility of the vice chancellor of research and the Faculty of Dentistry of Mazandaran Faculty of Medical Sciences, as well as the supervisor.
To whom data/document is available
Vice chancellor of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor
Under which criteria data/document could be used
To submit the final report and write the article
From where data/document is obtainable
Vice chancellor of Research, Faculty of Dentistry, Mazandaran University of Medical Sciences and also a supervisor
What processes are involved for a request to access data/document
Written request to the research assistant or the school of
Dentistry of Mazandaran University of Medical Sciences and
obtaining the consent of the supervisor