Protocol summary

Study aim
Comparison of the analgesic effect of Meloxicam and Ibuprofen on post endodontic pain
Design
Twenty-two patients with irreversible pulp recognition and two lateral tooth (left and right), will be selected .This study is clinical trial and double blind.
Settings and conduct
Twenty-two patients with irreversible pulp recognition and two lateral tooth (left and right), will be selected .This study is clinical trial and double blind.This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Recognize pulpitis irreversible, Both of gender Exclusion criteria:Lack of cooperation
Intervention groups
We treat patients in Ibuprofen group by 11 tab of Ibuprofen 400 milligram(Aria,Tehran,Iran). We treat patients in Meloxicam group by 11 tab of Meloxicam 7.5 milligram(Zahravi,Tabriz,Iran).
Main outcome variables
Pain

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141209020258N109
Registration date: 2019-04-27, 1398/02/07
Registration timing: registered_while_recruiting

Last update: 2019-04-27, 1398/02/07
Update count: 0
Registration date
2019-04-27, 1398/02/07
Registrant information
Name
Fariba Farokhi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3222 2003
Email address
f.farokhi@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the analgesic effect of Meloxicam and Ibuprofen on post endodontic pain
Public title
Comparison of the analgesic effect of Meloxicam and Ibuprofen on post endodontic pai
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Recognize pulpitis irreversible Both of gender
Exclusion criteria:
Lack of cooperation
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Simple individual randomization with random number table in division of groups in two groups A and B. Randomization method: Simple randomization. Random unit: Individual. How to build sequences: First, we set the framework for our statistical society. We started from a table point in a row or column. Given the type of code in the row, we chose the same number of digits. After that, the numbers control the path. We noticed smaller numbers of the statistical community. We have to continue this work so that the number of samples is completed.Even numbers were used for intervention group and odd numbers were used for the control group. Allocation concealment:Numbered drug containers
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is double blind. Researcher who complete questionnaire and analyzer are blind (double blind).Outcome assessor and analyzer don't aware from grouping.The person evaluating the outcome is unaware of the grouping. Groups A and B are available to analyzer and outcome assessor.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee Arak University Of Medical Sciences
Street address
Vice chancellor for research, Payambar azam complex, Basij squre, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
38149578558
Approval date
2019-01-13, 1397/10/23
Ethics committee reference number
IR.ARAKMU.REC.1397.284

Health conditions studied

1

Description of health condition studied
pulpitis irreversible
ICD-10 code
K04.0
ICD-10 code description
Pulpitis

Primary outcomes

1

Description
Pain
Timepoint
After 2 weeks
Method of measurement
Analog Visual scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: We treat patients in Ibuprofen group by 11 tab of Ibuprofen 400 milligram(Aria,Tehran,Iran).
Category
Treatment - Drugs

2

Description
Intervention group: We treat patients in Meloxicam group by 11 tab of Meloxicam 7.5 milligram(Zahravi,Tabriz,Iran).
Category
Treatment - Drugs

3

Description
Intervention group: We treat patients in Ibuprofen group by 11 tab of Ibuprofen 400 milligram(Aria,Tehran,Iran).
Category
Treatment - Drugs

4

Description
Intervention group: We treat patients in Meloxicam group by 11 tab of Meloxicam 7.5 milligram(Zahravi,Tabriz,Iran).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental clinic
Full name of responsible person
Dr Najmeh Kermani
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
kermani@arakmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor For Research, Arak University Of Medical Science
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Vice Chancellor For Research, Arak University Of Medical Science
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3645
Email
arjmandzadegan@arakmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor For Research, Arak University Of Medical Science
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
Arak University of Medical Sciences
Full name of responsible person
Dr Najmeh Kermani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
kermani@arakmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Najmeh Kermani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
kermani@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Raziye Zokaei
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Payambar Azam Complex, Basij square, Sardasht, Arak
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3417 3505
Email
raziyezokaei73@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
When we publish article in journal
When the data will become available and for how long
After the article is published
To whom data/document is available
researcher in university
Under which criteria data/document could be used
If there are additional questions
From where data/document is obtainable
Dr Kermani
What processes are involved for a request to access data/document
They have to write letters to the professors and the university
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