The aim of the present study is to investigate the effect of Iranian propolis mouthwash compared to chlorhexidine mouthwash on the complications (pain, swelling and trismus) after surgery of the impacted third molar of the mandible.
Design
Clinical trial with control group with parallel groups, double-blind, randomized, on 40 patients.
Settings and conduct
Patients referred to the maxillofacial surgeon's office for the surgery of the impacted third molar of the mandible,
The surgical conditions are the same for both intervention and control groups. After surgery, the intervention group uses propolis mouthwash and the control group uses 0.2% chlorhexidine mouthwash for one week.
On the second and seventh days after the surgery, the amount of swelling, the maximum opening of the mouth, the pain and the number of painkillers consumed are recorded. the surgeon and the patient did not know which mouthwash they used. .
Participants/Inclusion and exclusion criteria
Including healthy people (ASA I or II)
Impacted third molar of the mandible (with vertical impact and grade I and A according to the Pell and Gregory criteria)
Exclusion criteria include pregnant and lactating people, people under 18 years of age and people who were allergic to honey or used tobacco.
Intervention groups
After the surgical procedure, the intervention group was given a 240 ml bottle containing Iranian propolis mouthwash, and the control group was given a 240 ml bottle containing 0.2% chlorhexidine mouthwash according to the usual procedure of oral surgeries. The patients were taught that for a week. Twice a day after breakfast and before going to bed, swish 15 ml of mouthwash in the mouth for one minute and then take it out of the mouth .
Main outcome variables
The effect of two mouthwashes on pain, swelling and mouth opening rate was similar
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230212057392N1
Registration date:2024-11-03, 1403/08/13
Registration timing:retrospective
Last update:2024-11-03, 1403/08/13
Update count:0
Registration date
2024-11-03, 1403/08/13
Registrant information
Name
Faezeh Aghamolaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3216 4121
Email address
faezeh.aghamolaei1997@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-21, 1401/03/31
Expected recruitment end date
2022-09-20, 1401/06/29
Actual recruitment start date
2022-06-21, 1401/03/31
Actual recruitment end date
2022-09-21, 1401/06/30
Trial completion date
2022-10-18, 1401/07/26
Scientific title
Evaluation of the effect of Iranian Propolis mouthwash on some complications of mandibular impacted third molar surgery
Public title
Evaluation of the effect of Iranian Propolis mouthwash on some complications of mandibular impacted third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy people (ASA I or II)
The impacted third molar of the mandible (with vertical impact and grades I and A according to the Pell and Gregory criteria
People have not taken any type of antibiotics at least two weeks before surgery
Exclusion criteria:
Pregnant and lactating people
People under 18 years old
People who are allergic to honey
Tobacco user
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The people who referred to the personal office of oral, maxillofacial surgery specialist for mandibular impacted third molar surgery were randomly divided into two equal control and intervention groups .Randomization was carried out in such a way that patients were given numbers according to the day and time of their visit to the office, and the numbers were randomly assigned to two intervention and control groups using Excel.
Blinding (investigator's opinion)
Double blinded
Blinding description
The packaging bottles of the two mouthwashes had a completely similar appearance, and the surgeon and the patient did not know which mouthwash they had used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Rafsanjan University of Medical Sciences
Street address
Central Organization - Imam Ali Boulevard
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2022-06-07, 1401/03/17
Ethics committee reference number
IR.RUMS.REC.1401.049
Health conditions studied
1
Description of health condition studied
A patient who needs surgery for an impacted third molar of the mandible (with vertical impaction and grades I and A according to the Pell and Gregory criteria
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
swelling
Timepoint
Before surgery, the second and seventh days after surgery
Method of measurement
The amount of swelling was measured based on the change of facial reference points. The distances between the reference points were measured and recorded using a cloth meter. These distances included the tragus to the midline of the tooth and the angle of the mandible to the midline of the tooth, which was measured with a tape measure.
2
Description
The maximum amount of mouth opening
Timepoint
Before surgery, the second and seventh days after surgery
Method of measurement
The patient was asked to open his mouth straight as far as he could so that he did not have any jaw deviation and did not suffer pain, then the distance between the upper and lower centers was measured with a ruler.
3
Description
Pain
Timepoint
Second and seventh day after surgery
Method of measurement
Visual analog scale control and evaluation method
4
Description
Number of painkillers used
Timepoint
Second and seventh day after surgery
Method of measurement
questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the surgical procedure, the intervention group was given Iranian propolis mouthwash. The mouthwash used contained 1% propolis with a salt concentration of 0.25%, which was prepared in the laboratory of the Faculty of Dentistry. The patient was instructed to swish 15 ml of mouthwash in the mouth for one minute for a week, twice a day after breakfast and before bed, and then remove it from the mouth, and to refrain from eating and drinking for 30 minutes.
Category
Treatment - Drugs
2
Description
Control group: For the control group, according to the usual oral surgery procedure, a bottle containing 0.2% chlorhexidine mouthwash (V-One, Tabriz, Iran) was given. The patient was instructed to swish 15 ml of the mouthwash in the mouth for one minute twice a day for one week after breakfast and before going to bed, and then to remove it from the mouth, and to refrain from eating or drinking for 30 minutes. It should be noted that the packaging bottles of the two mouthwashes had a completely similar appearance. surgeon and the patient were unaware of which mouthwash they had used. Also, patients were not allowed to use any other mouthwash during the study period.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Oral and maxillofacial surgery specialist's private office
Full name of responsible person
Dr.Ali peimani mojaver
Street address
5Ave ,Modares street
City
Rafsanjan
Province
Kerman
Postal code
7717747135
Phone
+98 34 3426 6473
Email
Alipeimani2001@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Building No. 3 - Central Organization - Imam Ali Blvd.
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0086
Email
vcrt@rums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali nabavizade
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry , Muftah St
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0031
Email
alinabavizadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Nabavizade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Muftah St.
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0008
Email
alinabavizadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Ali Nabavizade
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry ,Muftah St.
City
Rafsanjan
Province
Kerman
Postal code
7717931136
Phone
+98 34 3428 0008
Email
alinabavizadeh@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
No - There is not a plan to make this available
Clinical Study Report
Yes - There is 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
Only a part of the data, such as the information related to the main result or the like, can be shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Respecting the author's rights
From where data/document is obtainable
through the mail address faezeh.aghamolaei1997@gmail.com
What processes are involved for a request to access data/document
A period of one month after the request by postal address