Comparison of anti-plaque and anti-inflammatory effects of sage (Salvia Officinalis) herbal mouthwash with chlorhexidine
Design
This study is a double-blind clinical trial in a parallel design. The study population will include all patients referred to the School of Dentistry, Islamic Azad University of Isfahan. 63 eligible people will be selected conveniently. Simple randomization is used for randomization and participants are assigned to three intervention groups.
Settings and conduct
This study will be performed in the School of Dentistry of the Islamic Azad University of Isfahan. In this double-blinded study, the researcher and the patient will keep blind to the allocation of study groups and the type of drug received. After health education for patients, mouthwash will be provided to patients by the project partner.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age between 20-65;At least 20 teeth with moderate inflammation
Exclusion criteria: Patients with any systemic disease; Pregnant and breastfeeding women; People who have taken any antibiotics in the last six months or are allergic to any type of antibiotic; People who have had scaling and gum surgery in the last six months; Smokers
Intervention groups
In the first intervention group, patients are asked to rinse 10 ml of mouthwash around their mouth for about 1 minute twice a day for 2 weeks (morning and night and expel it. In the second intervention group, patients are asked to spin 10 ml of mouthwash (2% chlorhexidine 2) in their mouth twice a day (morning and night) for 2 weeks and excrete it. In the third intervention group, patients are asked to spin 10 ml of mouthwash (Salvia) in their mouth twice a day (morning and night) for 2 weeks and excrete it
Main outcome variables
Inflammation of the gums, plaque index
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N183
Registration date:2022-02-19, 1400/11/30
Registration timing:prospective
Last update:2022-02-19, 1400/11/30
Update count:0
Registration date
2022-02-19, 1400/11/30
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-01, 1400/12/10
Expected recruitment end date
2022-04-30, 1401/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of anti-plaque and anti-inflammatory effects of sage (Salvia Officinalis) herbal mouthwash with chlorhexidine
Public title
Comparison of the effects of sage (Salvia Officinalis) herbal mouthwash with chlorhexidine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-65
At least 20 teeth with moderate inflammation
Exclusion criteria:
Patients with any systemic disease
Pregnant and breastfeeding women
People who have taken any antibiotics in the last six months or are allergic to any type of antibiotic
People who have had scaling and gum surgery in the last six months
Smokers
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
63
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. 62 cards will be selected and two-digit, three-digit and four-digit numbers will be inserted on them, and after selecting the cards by the project partner, patients will be placed in the first, second and third intervention groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
All three mouthwashes will be provided to patients in the same package and in coded form. Researchers and patients were kept blind to the type of mouthwash and the allocation of intervention groups.
Placebo
Not 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)
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Approval date
2021-12-22, 1400/10/01
Ethics committee reference number
IR.IAU.KHUISF.REC.1400.295
Health conditions studied
1
Description of health condition studied
Inflammation of the gums
ICD-10 code
K05.0
ICD-10 code description
Acute gingivitis
Primary outcomes
1
Description
Inflammation of the gums
Timepoint
Start of study and end of study (after two weeks)
Method of measurement
Physician examination
2
Description
Plaque index
Timepoint
End of study (after two weeks)
Method of measurement
Physician examination
Secondary outcomes
empty
Intervention groups
1
Description
In the first intervention group, patients are asked to rinse 10 ml of mouthwash around their mouth for about 1 minute twice a day for 2 weeks (morning and night and expel it.
Category
Treatment - Other
2
Description
In the second intervention group, patients are asked to spin 10 ml of mouthwash (2% chlorhexidine 2) in their mouth twice a day (morning and night) for 2 weeks and excrete it.
Category
Treatment - Other
3
Description
. In the third intervention group, patients are asked to spin 10 ml of mouthwash (Salvia) in their mouth twice a day (morning and night) for 2 weeks and excrete it
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Islamic Azad University of Isfahan
Full name of responsible person
Dr. Vahid Esfahanian
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
vahid.esfahanian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
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
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
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Vahid Esfahanian
Position
Faculty member of Esfahan Free University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 13 3323 8306
Email
vahid.esfahanian@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Vahid Esfahanian
Position
Faculty member of Esfahan Azad University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
vahid.esfahanian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Vahid Esfahanian
Position
Faculty member of Esfahan Azad University
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
University Blvd, Arghavaniyeh, East Jay St.
City
Esfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
vahid.esfahanian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD