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A comparative study of analgesic effects of Ibuprofen, Novafen, Mefenamic acid and Celecoxib in relieving pain of symptomatic pulpitis before emergency endodontic intervention

Protocol summary

Study aim
A comparative study of analgesic effects of Ibuprofen, Novafen, Mefenamic acid and Celecoxib in relieving pain of symptomatic pulpitis before emergency endodontic intervention
Design
In this study, 120 patients selected from the Department of Endodontics, Faculty of Dentistry, Kerman, who have been diagnosed with symptomatic pulpitis and had moderate to severe pain (VAS above 3), will be able to take immediate medical treatment in their department. There are no patients with any drug interactions or systemic diseases. People are divided into 4 groups of 30 people who give each group a specific home
Settings and conduct
This study was conducted to compare Ibuprofen, Naufafen, Mefenamic acid and Celecoxib with dentinal pain relief in symptomatic pulpitis patients before endodontic treatment. A total of 120 patients referred to the endodontics department of Kerman dental school, The root that has been diagnosed with symptomatic pulp is given that the VAS is above 3 and have the conditions for entry into the study, will be selected.The patients are divided into 4 groups of 30, each of whom has a specific type of housing that has the powder of the analgesics in the same capsule so that both the designers and the patients will be unaware of the type of drug. Also, the code The drug groups will be opened and identified after the statistical review. The statistician will also be aware of the type of drug and the groups studied.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The patient has an irreversible acute pulpitis, diagnosed by a dentist; Lack of medical problem (20) (such as history of stroke or heart failure, heart failure, blood pressure, asthma, nasal polyps, liver or kidney disease, gastric ulcer, systemic lupus, blood clotting problems, etc.); Access to the patient; Patients without oral and history of corticosteroid susceptibility are nonsteroidal inflammation; The teeth should be permanent and apex; Failure to quickly deal with endodontic emergencies; Patient Satisfaction and Compliance Form Completion; Do not be pregnant, pregnant or breastfeeding. Exit criteria: Patients who have received housing for up to 6 hours; Patients who for any reason prohibit the use of the drugs studied.
Intervention groups
In this study, we divided the patients into four groups, which divided the first group of ibuprofen, the second group of naufaffen, into the third group of mefenamic acid, and the fourth group of celecoxib, to determine the most effective drug in reducing the pain of patients with severe irreversible pulpitis.
Main outcome variables
The results of our research can help the dentist to control and reduce the pain and discomfort to the patients due to the severity of the pain and the effects of various types of analgesics (ibuprofen, naufafen, mefenamic acid and celecoxib). Has an irreversible acute pulpitis in the pre-endodontic treatment.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171109037332N1
Registration date: 2018-01-06, 1396/10/16
Registration timing: registered_while_recruiting

Last update: 2018-01-06, 1396/10/16
Update count: 0
Registration date
2018-01-06, 1396/10/16
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32118022
Email address
h.kamyabi1244@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-01, 1396/09/10
Expected recruitment end date
2019-01-20, 1397/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of analgesic effects of Ibuprofen, Novafen, Mefenamic acid and Celecoxib in relieving pain of symptomatic pulpitis before emergency endodontic intervention
Public title
Comparison of the effect of Ibuprofen, Naufafen, Mefenamic acid and Celecoxib on the improvement of dental pain in the stage before the endodontic emergencies
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has an irreversible acute pulpitis, diagnosed by a dentist; Lack of medical problem (20) (such as history of stroke or heart failure, heart failure, blood pressure, asthma, nasal polyps, liver or kidney disease, gastric ulcer, systemic lupus, blood clotting problems, etc.); Access to the patient; Patients without oral disease and history of corticosteroid susceptibility are nonsteroidal inflammation; The teeth should be permanent with closed apex; Failure to quickly deal with endodontic emergencies; Patient satisfaction and compliance form completion
Exclusion criteria:
Patients who have received a home for up to 6 hours before; Patients who for any reason prohibit the use of the drugs studied.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
  • Data analyser
Sample size
Target sample size: 120
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
In each group, the company will take 30 pills of powdered detergents and will be placed inside a blank capsule. So that both the project executives and the patients will be unaware of the type of medication. Also, the code of the drug groups will be revealed and determined after the statistical review. The statistician will also be aware of the type of medication and the groups being studied.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences
Street address
Blvd.Heft Gardens Alavi-Pardis University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2017-11-17, 1396/08/26
Ethics committee reference number
IR.KMU.REC.1395.1002

Health conditions studied

1

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

Primary outcomes

1

Description
Intensity of pain
Timepoint
Measure the severity of pain at the beginning of the study (before the intervention) and 1 hour after taking the drug
Method of measurement
Visual Analogue Scale

Secondary outcomes

empty

Intervention groups

1

Description
First Intervention group: Ibuprofen 400 once
Category
Other

2

Description
Second intervention group: Novafer once, containing 325 mg of acetaminophen, 40 mg of caffeine and 200 mg of ibuprofen.
Category
Other

3

Description
Third intervention group: Mefenamic acid 250 once
Category
Other

4

Description
Fourth intervention group: Celecoxib 200 once
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
School of Dentistry, Kerman University of Medical Sciences
Full name of responsible person
rahim fereidooni
Street address
Shafa St., Faculty of Dentistry
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9028
Email
endo_kerman@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
abbas pardakhti
Street address
Boulevard of Al-Awli Gardens, Kerman University of Medical Sciences
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5700
Email
endo_kerman@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Homa kamyabi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shafa St., School of Dentistry
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9028
Fax
Email
h.kamyabi1244@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
arash shahravan
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa St., Faculty of Dentistry
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+34 32119028
Fax
Email
arashahravan@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Homa kamyabi
Position
Dentistry student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shafa St., Faculty of Dentistry
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9028
Fax
Email
h.kamyabi1244@gmail.com
Web page address

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
No - There is not 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
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable peopleav,u n,
When the data will become available and for how long
Start the access period 6 months after printing the results
To whom data/document is available
Data will only be available to researchers in academia and academia
Under which criteria data/document could be used
There are no other conditions for using data
From where data/document is obtainable
Homa Kamyabi, h.kamyabi1244@gmail.com Dr Rahim Fereidooni, rahim.fereidooni71@yahoo.com Dr Arash Shahravan,l arashahravan@gmail.com
What processes are involved for a request to access data/document
The applicant sends emails to each researcher and their introduction and reasons for requesting data at the latest after one month of data
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