Evaluation of the effect of Arnica-Rosemary cream on swelling, trismus and pain following impacted mandibular third molar surgery: A triple-blind, clinical trial study
Evaluation of the effect of Arnica-Rosemary cream on swelling, trismus and pain following impacted mandibular third molar surgery
Design
A clinical trial with parallel intervention and control groups , triple-blinded, randomized and is performed on 30 patients using random allocation software.
Settings and conduct
This study is performed in Qazvin Dental School. After surgery, patients use a coded syringe containing arnica-rosemary or placebo, the contents of which the patient, examiner, and statistician are unaware of and is prepared by someone outside the study.
Participants/Inclusion and exclusion criteria
Having panoramic radiographs of appropriate quality and prepared in the last 6 months
not having any systemic disease
not using drugs, cigarettes, alcohol and drugs (especially corticosteroids)
Non-pregnancy and lactation in women
Patient willingness and satisfaction to participate in the study
Proper patient cooperation
Intervention groups
Patients are divided into two groups, one group receiving rosemary arnica cream and the other group receiving placebo.
Main outcome variables
pain, swelling, trismus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170502033761N2
Registration date:2022-06-18, 1401/03/28
Registration timing:prospective
Last update:2022-06-18, 1401/03/28
Update count:0
Registration date
2022-06-18, 1401/03/28
Registrant information
Name
mahdieh zarabadipour
Name of organization / entity
Qazvin university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 28 3335 3061
Email address
mzarabadipour@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-23, 1401/05/01
Expected recruitment end date
2022-10-23, 1401/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Arnica-Rosemary cream on swelling, trismus and pain following impacted mandibular third molar surgery: A triple-blind, clinical trial study
Public title
Evaluation of the effect of Arnica-Rosemary cream on swelling, trismus and pain following impacted mandibular third molar surgery: A triple-blind, clinical trial study
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a panoramic view radiography with good quality taken in the past 6 months
No systemic diseases
No use of drugs, cigarettes, alcohol (specially corticosteroids)
Non pregnant or lactating women
Patient's willingness and satisfaction to participate
Proper patient cooperation
Exclusion criteria:
complications during surgery
Patient non-cooperation
Age
From 18 years old to 40 years old
Gender
Both
Phase
4
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups of intervention and placebo using Random allocation software. Working with this software is such that it provides an order of numbers with a completely random and irregular sequence. The researcher pre-defines how to assign these numbers to study groups and proceeds accordingly.
Blinding (investigator's opinion)
Triple blinded
Blinding description
after surgery patients use a coded syringe containing arnica-rosemary or placebo that the patient, examiner and statistician do not know the contents of and is prepared by a person who is not a participant 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 Qazvin University of Medical Sciences
Street address
Qazvin university of medical sciences, Bahonar Blvd, Qazvin city
City
qazvin
Province
Qazvin
Postal code
3419915315
Approval date
2020-11-29, 1399/09/09
Ethics committee reference number
IR.QUMS.REC.1399.343
Health conditions studied
1
Description of health condition studied
pain, swelling, truisms
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Patient's Visual Analogue score score
Timepoint
Pain is measured before and immediately after surgery, as well as 3, 7, and 14 days after surgery.
Method of measurement
Pain is assessed by the Visual Anaolgue Score.
2
Description
swelling measurements in millimeter
Timepoint
Swelling is measured before and immediately after surgery, as well as 3, 7, and 14 days after surgery.
Method of measurement
Swelling is measured by constant facial distances with a 4-0 vicryl thread and a millimeter-scale ruler.
3
Description
maximum mouth opening in millimeter
Timepoint
Trismus is measured before and immediately after surgery, as well as 3, 7, and 14 days after surgery.
Method of measurement
Trismus is assessed by a caliper by measuring the maximum distance between the edges of the upper and lower incisor teeth.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Arnica-Rosemary demulcent la farrerr cream Dr. Kamkar International and Research Laboratories Company for two weeks, 2 times a day and each time 1 milliliter.
Category
Treatment - Drugs
2
Description
Control group: Placebo for two weeks, 2 times a day and each time 1 milliliter.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
dental faculty of Qazvin university of medical sciences
Full name of responsible person
Dr. Pejman Janbaz Asiabar
Street address
Qazvin university of medical sciences, Bahonar Blvd, Qazvin city
City
qazvin
Province
Qazvin
Postal code
3419915315
Phone
+98 28 3333 6001
Email
mzarabadipour@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Mahdi Mirhashemi
Street address
Qazvin university of medical sciences, Bahonar Blvd
City
qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3333 6001
Email
mzarabadipour@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Pejman Janbaz
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Qazvin university of medical sciences, Bahonar Blvd
City
qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3333 6001
Email
pejmanjanbaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Pejman Janbaz
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
qazvin university of medical sciences, bahonar blvd
City
qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3333 6001
Email
pejmanjanbaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr. Pejman Janbaz
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
qazvin university of medical sciences, bahonar blvd
City
qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3333 6001
Email
pejmanjanbaz@yahoo.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
All personal information of study participants and information about the main outcomes will be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
Data available to academic researchers
Under which criteria data/document could be used
There are no other conditions.
From where data/document is obtainable
Qazvin university of medical sciences
faculty of dentistry
00982833336001
What processes are involved for a request to access data/document
Contact with the research unit of Qazvin University of Medical Sciences