Comparison study of Citrullus Colocynthis (L.) schrad oil and Dentol drop on tooth pain reduction
Design
Clinical trial with control group, with parallel groups, blind, randomized With a sample size of 60 people
Settings and conduct
The study will be carried out at the Dental Clinic of Khorram-Abad Dental College, Lorestan University of Medical Sciences. Persons entering the study will receive written consent consciously and the questionnaire will be completed through the interview. Through the Visual Analogue Scale, The patient's pain number is recorded. Then the drug is placed on the pain location and after 10 minutes the drug is removed from the patient's mouth and the patient's pain number is re-recorded. The data is compared and the final report is prepared.
For blinding, drugs are encoded in the same packages by the original investigator and delivered to responsible for collecting data who is unaware of the contents of the packages and is selected by sortition a package for each patient. The patient will also be unaware of the drug given to him.
Participants/Inclusion and exclusion criteria
Entry conditions: Age of 40-18 years, Tooth pain
Exit Conditions: Pregnancy, Hypertension, Diabetes, Heart disease, Immune system disorders, Unwillingness to cooperate
Intervention groups
Group 1: Cotton bullet impregnated with 0.2 ml of Citrullus Colocynthis (L.) schrad oil is applied locally to the tooth that is in pain for 10 minutes.
Group 2: Cotton bullet impregnated with 0.2 ml of Dentol drop is applied locally to the tooth that is in pain for 10 minutes.
Group 3: Cotton bullet impregnated with 0.2 ml of sesame oil (placebo) is applied locally to the tooth that is in pain for 10 minutes.
Main outcome variables
Intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181230042172N1
Registration date:2019-01-20, 1397/10/30
Registration timing:prospective
Last update:2019-01-20, 1397/10/30
Update count:0
Registration date
2019-01-20, 1397/10/30
Registrant information
Name
Ehsan Hamzelouei Moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3320 7826
Email address
hamzelouei.e@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-24, 1397/11/04
Expected recruitment end date
2019-02-23, 1397/12/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Citrullus colocynthis (L.) Schrad oil and Dentol drop on tooth pain reduction: Double blind randomized clinical trial
Public title
Comparison of Citrullus colocynthis (L.) Schrad oil and Dentol drop on tooth pain reduction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy clients suffering from tooth pain referring to the dental clinic of Khorramabad dental college, Lorestan University of Medical Sciences in 2019
Those aged 18 to 40 years old
Exclusion criteria:
Pregnants
Patients in ASA ll or more health status
Patients have taken analgesics and antibiotics in 12 hours before the test
Fail in cooperation
Those who have a history of allergy to Citrullus colocynthis (L.) Schrad
Those who use drug and alcohol
Those who have a disorder of the immune system
Age
From 18 years old to 40 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
ُSimple randomization is done based on Sortition
Blinding (investigator's opinion)
Double blinded
Blinding description
The outcome evaluator and patients are kept blind. Test samples are coded in similar size and packages by investigator and it is given to the outcome evaluator, who is unaware of the contents of each package. After obtainig informed consent from the patient and the necessary explanations about the study and their safety and completing the questionnaire. Then clinician will take one of the packages and write the code in questionnaire before starting the test.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Lorestan University of Medical Sciences
Street address
Deputy of research and technology, Lorestan University of Medical Sciences, Academic Complex Kamalvand
City
Khorramabad
Province
Lorestan
Postal code
6814989468
Approval date
2018-12-31, 1397/10/10
Ethics committee reference number
IR.LUMS.REC.1397.141
Health conditions studied
1
Description of health condition studied
Tooth pain
ICD-10 code
K04.0
ICD-10 code description
Diseases of pulp and periapical tissues-Pulpitis-irreversible
Primary outcomes
1
Description
Score pain severity on the Visual Analogue Scale
Timepoint
Before the intervention and 10 minutes after the intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Cotton bullet impregnated with 0.2 ml of Citrullus colocynthis (L.) Schrad TOUBA company topically for 10 minutes on a tooth that is painful
Category
Treatment - Drugs
2
Description
Intervention group: Cotton bullet impregnated with 0.2 ml of ِDentol drop Khorraman company topically for 10 minutes on a tooth that is painful.
Category
Treatment - Drugs
3
Description
Control group: Cotton bullet impregnated with 0.2 ml of sesame oil topically for 10 minutes on a tooth that is painful.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Dental College, Khorramabad University of Medical Sciences
Full name of responsible person
Ehsan Hamzelouei Moghadam
Street address
Razi St., Khorramabad Dental College
City
Khorramabad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3320 7826
Email
dr.hamzelouei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Sara Mohammadi Sepahvand
Street address
Razi St., Khorram-Abad College of Dentistry
City
Khorram-Abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3320 7826
Email
smohammadis@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khoram-Abad University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ehsan Hamzelouei Moghadam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Razi St., Khorram-Abad Dental College
City
Khorram-Abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3320 7826
Email
dr.hamzelouei@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Ehsan Hamzelouei Moghadam
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Razi St., Khorram-Abad Dental College
City
Khorram-Abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3320 7826
Email
dr.hamzelouei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Mina Asadzadeh
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Razi St., Khorram-Abad Dental College
City
Khorram-Abad
Province
Lorestan
Postal code
6813833946
Phone
+98 66 3322 4879
Email
mina.asadzadeh23@mailfa.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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data is accessible after being unrecognizable
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
All researchers have access to data
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
Dental College, Lorestan University of Medical Sciences
What processes are involved for a request to access data/document