Comparison of salivary Streptococcus mutans species density in two groups of chlorhexidine mouthwash and licorice extract
Design
Single-group, single-blind, randomized controlled clinical trial on 60 patients.
Settings and conduct
60 patients with dental caries referred to the Oral Diseases Department of Tabriz Dental School will be randomly divided into two groups (30 people in each group). Licorice plant gel will be used in the intervention group and mouthwash containing 0.2% chlorhexidine will be used in the control group. . Quantification of Streptococcus mutans species in saliva samples of patients will be done using culture method. Mouthwash and gel will be poured into bottles. The evaluator of the number of Streptococcus mutans colonies in the saliva sample will not be aware of the grouping method (one-sided blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age range from 18 to 55 years
Good oral hygiene (using SOHI (simplified oral hygiene index) based on DIS (debries index) and CIS (calculus index). Based on this index, which includes the sum of CIS and DIS index, oral hygiene is from zero to number 6 Good health in this index is equal to the interval between zero and 1/2.
Patients with average DMFT index above 2 (high-risk caries)
Patients willing to participate in the study
Exit criteria
pregnancy
high blood pressure
a smoker
Severe periodontal disease
Patients who have taken antibiotics 2 weeks before the intervention.
Patients who take antibiotics during the study.
Patients who are allergic to licorice or it is harmful to them.
Intervention groups
Intervention group: mouthwash containing licorice extract gel will be used.
Control group: 0.2% chlorhexidine mouthwash will be used.
Main outcome variables
Measuring of Streptococcus mutans microbial load in saliva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048756N7
Registration date:2023-09-11, 1402/06/20
Registration timing:prospective
Last update:2023-09-11, 1402/06/20
Update count:0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Solmaz Maleki Dizaj
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 3161
Email address
maleki.s.89@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-06, 1402/07/14
Expected recruitment end date
2024-10-05, 1403/07/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of licorice extract gel and 0.2% chlorhexidine mouthwash on the amount of Streptococcus mutans in saliva.
Public title
Comparing the effects of licorice extract gel and 0.2% chlorhexidine mouthwash on the amount of Streptococcus mutans in saliva.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range from 18 to 55 years
good oral hygiene (using SOHI (simplified oral hygiene index)
Patients willing to participate in the study
Exclusion criteria:
pregnancy
high blood pressure
being a smoker
Severe periodontal disease
Patients who have taken antibiotics 2 weeks before the intervention
Patients who take antibiotics during the study
Patients who are allergic to licorice or it is harmful to them
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 patients are placed in two intervention and control groups using the randomization method of coin toss (tap and line) in such a way that one group is considered tap and the other group is considered line and based on the desired sample size, the same The number of coins is thrown and people are assigned to two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Mouthwash and gel will be poured into bottles. The active form of chlorhexidine mouthwash prepared for the control group is chlorhexidine hydrochloride. The evaluator of the number of Streptococcus mutans colonies in the saliva sample will not be aware of the grouping method (one-sided blind).
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2023-08-07, 1402/05/16
Ethics committee reference number
IR.TBZMED.REC.1402.345
Health conditions studied
1
Description of health condition studied
Infection or inflammation of the oral environment
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reducing the microbial load of saliva
Timepoint
Saliva sampling will be done in two stages: one stage before starting to consume the formulations (extract and mouthwash) and the second sampling at the end of one week after consuming the formulations.
Method of measurement
The prepared saliva samples are sent to the microbiology laboratory of Tabriz University of Medical Sciences to count the colonies by a microbiologist.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: use of licorice extract mouthwash
Category
Prevention
2
Description
Control group: Chlorhexidine mouthwash 2%
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences
Full name of responsible person
دکتر پریا مطهری
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 3161
Email
paria.motahari@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research and Technology, Tabriz University of Medical Sciences
Street address
Golgasht St, Tabriz University of Medical Sciences, Central Building No. 2 / Third Floor, Vice Chancellor for Research and Technology
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Paria Motahari
Position
استادیار
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht St, Daneshgah Ave, Tabriz University of Medical Sciences, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Email
paria.motahari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Solmaz Maleki Dizaj
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Nanotechnology
Street address
Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 3161
Fax
Email
maleki.s.89@gmail.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
Yes - There is 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
The data will be published as an article.
When the data will become available and for how long
After the final publication of the article resulting from the data.
To whom data/document is available
Public
Under which criteria data/document could be used
For use in research articles and systematic reviews with citation.
From where data/document is obtainable
Dr. Solmaz Maleki Dizaj, Tabriz Faculty of Dentistry
What processes are involved for a request to access data/document