Studying the effect of herbal mouthwash (propolis) on the reduction of gingival index, plaque index, and prevalence of dry socket in impacted mandibular wisdom teeth compared to chlorhexidine
Studying the effect of herbal mouthwash (propolis) on the reduction of gingival index, plaque index, and prevalence of dry socket in impacted mandibular wisdom teeth compared to chlorhexidine
Design
A phase 3, double-blind, randomized, parallel-group, controlled clinical trial was used on 60 patients for simple randomization.
Settings and conduct
The location of the study is the School of Dentistry. Patients will undergo a complete dental examination upon entering the study, complete a demographic information checklist, and be divided into two groups.
Participants/Inclusion and exclusion criteria
Entry requirements: Having impacted wisdom teeth in the lower jaw - Not using other mouthwashes - Plaque index and gum index
Conditions of non-entry: Pregnant people - People with cardiovascular problems - People who use antibiotic drugs for any reason
Intervention groups
Intervention group: Effect of herbal mouthwash (propolis)
Control group: Simultaneously uses chlorhexidine mouthwash.
Main outcome variables
The amount of gum index reduction-Prevalence of dry cavity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20241211064021N4
Registration date:2025-03-21, 1404/01/01
Registration timing:prospective
Last update:2025-03-21, 1404/01/01
Update count:0
Registration date
2025-03-21, 1404/01/01
Registrant information
Name
Faeze Noori
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3131 4033
Email address
ethics@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-12, 1404/01/23
Expected recruitment end date
2025-09-14, 1404/06/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying the effect of herbal mouthwash (propolis) on the reduction of gingival index, plaque index, and prevalence of dry socket in impacted mandibular wisdom teeth compared to chlorhexidine
Public title
Comparison of the effects of propolis and chlorhexidine mouthwash on oral health and impacted mandibular wisdom teeth
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having impacted wisdom teeth in the lower jaw
Not using other mouthwashes
Plaque index and gum index
Exclusion criteria:
Pregnant people
People with cardiovascular problems
People who use antibiotic medications for any reason
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used to implement random assignment. In this way, 60 consecutive numbers (from 1 to 60) will be written separately on paper and placed in a container. Then, each participant in the experiment will be asked to randomly select one of these 60 numbers from the container containing the numbers.People who chose numbers 1 to 30 will be assigned to Group A, and people who chose numbers 31 to 60 will be assigned to Group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
Propolis mouthwash and chlorhexidine mouthwash are produced with similar appearance, color, and odor. If possible, additives are used to make both mouthwashes look exactly the same. This is done to prevent the mouthwash from being identified based on appearance. Both mouthwashes are packaged in identical, indistinguishable bottles.In this type of blinding, neither the participants know which mouthwash they are receiving nor do the researchers who perform the clinical assessments (such as measuring gingival and plaque indices). The primary investigator codes the bottles (using numbers). This list is not made available to the researchers or participants until the end of the study.Participants are given coded bottles and told to use the mouthwash according to specific instructions (for example, twice a day after brushing their teeth).
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Hamadan University of Medical Sciences
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2024-11-23, 1403/09/03
Ethics committee reference number
IR.UMSHA.REC.1403.622
Health conditions studied
1
Description of health condition studied
Studying the effect of herbal mouthwash (propolis) on the reduction of gingival index, plaque index, and prevalence of dry socket in impacted mandibular wisdom teeth compared to chlorhexidine
ICD-10 code
K05.1
ICD-10 code description
Chronic gingivitis
Primary outcomes
1
Description
The amount of gum index reduction
Timepoint
Before intervention: Assessment of the initial condition before starting to use the mouthwash. After intervention: Assessment at specific times after the start of treatment, measured on days 7 and 14.
Method of measurement
They are measured using standard clinical methods, which include examination of the teeth and gums by a trained dentist and researcher. Instruments such as a probe are used to measure the depth of the gingival pocket or visual observation is used to determine the presence of plaque.
2
Description
Prevalence of dry cavity
Timepoint
Before intervention: Assessment of the initial condition before starting to use the mouthwash. After intervention: Assessment at specific times after the start of treatment, measured on days 7 and 14.
Method of measurement
It is usually assessed through clinical records and reports of complications from patients after wisdom tooth extraction.
Secondary outcomes
1
Description
Patients' perception of pain or discomfort
Timepoint
Before the intervention: To assess the initial condition of the patients. During the intervention: Periodic assessment (every week and every month) to observe changes.
Method of measurement
It is measured through rating scales (such as a 0 to 10 rating scale) in which patients report their level of pain.
Intervention groups
1
Description
Intervention group: The effect of herbal mouthwash (propolis) is to rinse your mouth with 10 ml of mouthwash for 30 seconds, one hour after brushing your teeth, twice a day (morning and night), as recommended by the manufacturer, and avoid eating and drinking, and preferably rinsing your mouth. This should be done starting the night of surgery and continuing for two weeks.
Category
Treatment - Drugs
2
Description
Control group: Simultaneously uses chlorhexidine mouthwash. This group serves as a benchmark for comparison with the effect of propolis.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Amir Najafi
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
atmonero@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Soltanian
Street address
Shahid Fahmideh St
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
atmonero@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Pouria Karimi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmedeh st
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
atmonero@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Amir Najafi
Position
Academic staff
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmedeh st
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
dr_amn69@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Pouria Karimi
Position
student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shahid Fahmedeh st
City
Hamadan
Province
Hamadan
Postal code
6517838678
Phone
+98 81 3131 0000
Email
atmonero@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
Yes - There is a plan to make this available
Title and more details about the data/document
Much of the data is potentially shareable
When the data will become available and for how long
Access to the data will be available immediately after the publication of the final article
To whom data/document is available
All researchers, researchers and clinical experts will be allowed to access the data of this study.
Under which criteria data/document could be used
It will be welcomed to conduct extensive analysis on the data of this study along with the data of other studies to write meta-analysis review articles.
From where data/document is obtainable
For more information, please send an email to Dr. Pouria Karimi. All correspondence will be sent to the email address: atmonero@gmail.com
What processes are involved for a request to access data/document
After making a phone call and submitting a request via email, the final answer will be sent within at least 1 month.