Determining the effect of herbal cardamom mouthwash with 0.2% chlorhexidine on plaque and gingivitis indices
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, performed on 23 patients
Settings and conduct
The study is performed in the School of Dentistry of Isfahan Azad University and patients are divided into three groups, including chlorhexidine mouthwash group, cardamom mouthwash group and placebo group, in which both patients and researchers are unaware of the contents of the bottle.
Participants/Inclusion and exclusion criteria
23 patients with gingivitis will be selected.
The patients should be free of any systemic disease and have not taken any medication that causes hyperplasia and bleeding gums in the last 6 months. Patients with periodontitis and recipients of periodontal treatments, smokers and pregnant women, and any other factor that affects the development and course of gum disease are excluded from the study.
Patients with symptoms of gingivitis, including gingival discoloration, bleeding when probing without loss of adhesion, and alveolar bone resorption in the probe are selected.
Intervention groups
Chlorhexidine mouthwash group
Cardamom mouthwash group
Placebo Group
Main outcome variables
Independent variable: mouthwash
Dependent variable: plaque index, gingivitis index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220525054989N1
Registration date:2022-07-31, 1401/05/09
Registration timing:retrospective
Last update:2022-07-31, 1401/05/09
Update count:0
Registration date
2022-07-31, 1401/05/09
Registrant information
Name
Zahra Aghajani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3212 6036
Email address
zaghajani736@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-29, 1401/04/08
Expected recruitment end date
2022-07-13, 1401/04/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of cardamom herbal mouthwash with 0.2% chlorhexidine on plaque index and gingival index
Public title
Comparison of the effect of cardamom herbal mouthwash with 0.2% chlorhexidine on plaque index and gingival index
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with gingivitis
Patients with symptoms of gingivitis, including gingival discoloration, bleeding when probing without loss of adhesion, and alveolar bone resorption in the probe are selected.
Exclusion criteria:
The patients studied should be free of any systemic disease
Do not take any medication that causes hyperplasia and bleeding gums in the last 6 months
Patients with periodontitis and recipients of periodontal treatments, smokers and pregnant women, and any other factor that affects the development and course of gum disease are excluded from the study.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
23
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The person is asked to pour both mouthwash and placebo into the bottles in a uniform and opaque shape and then bring it to the researcher so that both the person being studied and the researcher do not know what type of substance is inside the bottle. Participate in the study)
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University-Isfahan Branch (Khorasgan)
Street address
Kerman, 33 South Jomhuri Blvd., 3 Star Complex, Unit 8
City
kerman
Province
Kerman
Postal code
7617998596
Approval date
2022-05-30, 1401/03/09
Ethics committee reference number
IR.IAU.KHUISF.REC.1401.102
Health conditions studied
1
Description of health condition studied
Gingivitis
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
"The percentage of plaque before and after using mouthwash"
Timepoint
At the beginning of the study and 14 days later
Method of measurement
Disclosure tablets
2
Description
Gingivitis before and after using mouthwash
Timepoint
At the beginning of the study and 14 days later
Method of measurement
prob
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 0.5% cardamom mouthwash group. The treatment method is that cardamom mouthwash is swirled in the mouth twice a day for two weeks and every day for 30 seconds. Plaque and gingivitis index are measured by disclosing tablet and probe before and after using the mouthwash. Mouthwash concentration is 0.5 %. The mouthwash is made by Dr. Darusaz.
Category
Treatment - Drugs
2
Description
Intervention group: 0.2% chlorhexidine mouthwash group. The treatment method is that chlorhexidine mouthwash is swirled in the mouth twice a day for two weeks and every day for 30 seconds. Plaque and gingivitis index by disclosing tablet and probe before and after using the mouthwash. The concentration of the mouthwash is 0.2% and it is prepared from a pharmacy and is of the Behsa brand.
Category
Treatment - Drugs
3
Description
Control group: Placebo (water) group. The treatment method is that the water is swirled in the mouth twice a day for two weeks and every day for 30 seconds. The index of plaque and gingivitis is measured by disclosing tablets and probes before and after consuming water. In addition, water bottles are similar to mouthwash bottles.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran-Isfahan-Islamic Azad University (Khorasgan) -Dental School
Full name of responsible person
Zahra Aghajani
Street address
Unit 8-Star Complex -South3-Jomhouri Blvd. 33-kerman
City
Kerman
Province
Kerman
Postal code
7617998596
Phone
+98 34 3212 6036
Email
zaghajani736@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Majid Toghiani
Street address
Unit 8-Star Complex-South 3-Republic Blvd. 33-kerman
City
kerman
Province
Kerman
Postal code
7617998596
Phone
+98 913 562 0736
Email
zaghajani736@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Majid Toghiani
Street address
Research and Technology Deputy-Islamic Azad Uni
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
50
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
Islamic Azad University
Full name of responsible person
Ehsan Rafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan - Middle Tohid - Upper floor of Pasargad Bank - Negar Building 1 - 2nd floor - Unit 8
City
Isfahan
Province
Isfehan
Postal code
1234567859
Phone
+98 913 318 2508
Email
dr-ehsanrafiei@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ehsan Rafiei
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Isfahan - Middle Tohid - Upper floor of Pasargad Bank - Negar Building 1 - 2nd floor - Unit 8
City
Isfahan
Province
Isfehan
Postal code
1236459756
Phone
+98 913 318 2508
Email
dr-ehsanrafiei@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Zahra Aghajani
Position
University student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Kerman - Republic Boulevard - South 3 - Star Complex - Unit 8
City
Kerman
Province
Kerman
Postal code
7617998596
Phone
+98 34 3212 6036
Email
zaghajani736@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