to determine the effect of ibubrofenlysine with asetaminophen&gelofen after root canal therapy in teeth with ireversibie pulpitis
Design
.Clinical trial has a control group with parallel intervention, single blinded and randomise
Settings and conduct
The subjects were 60 people who were selected from individuals referring to the department of Endodontics of Kermanshah Dentistry School. Individuals are randomly divided into two groups of intervention and control. The type of intervention in the envelopes with A, B name Have been placed and the person giving the envelopes to patients is blinded to the type of intervention in each envelope.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Candidates for Root therapy
Age over 12 years
Ability to read and understand the visual analog scale
Exclusion criteria: Use of other anti pain drug before treatment; Cystic teeth;
Hopless teeth; sensitivity to the drugs present in the study; Age under 12 years ;liver problems; history of chemotherapy; Inability to read and understand the visual analog scale; Heart problems; Kidney disease; Stomach problem
Intervention groups
The intervention group 1 includes those who receive ibuprofen lysine 400 mg.
The intervention group 2 contains people who receive gelofen 400 mg and acetaminophen 500 mg.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140527017880N8
Registration date:2019-07-29, 1398/05/07
Registration timing:registered_while_recruiting
Last update:2019-07-29, 1398/05/07
Update count:0
Registration date
2019-07-29, 1398/05/07
Registrant information
Name
Roohollah Sharifi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1722 2400
Email address
r.sharifi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effect of ibuprofen lysine & gelofen - acetaminophen on postoperative endodontic dental pain with irreversible pulpaitis
Public title
Comparative evaluation of the effect of ibuprofen lysine & gelofen - acetaminophen on pain
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Candidates for Root thtapy
Age over 12 years
Ability to read and understand the visual analog scale
Exclusion criteria:
Useof other anti pain drug befor treatment
Cystic teeth
Hopless teeth
sensitivity to the drugs present in the study
Age under 12 years
liver problems
history of chemotherapy
Heart problems
Kidney disease
Stomach problem
Age
From 12 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
.We prepare 2 group packes first A and second B
We put in A packets ibubrofenlysin and in packets B gelofen with asetaminophen acourding to randomization number table .
packets A goes to pair number and packets B goes to unique number patients.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patient and who share the packets are unaware of packets contain
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Sciences
Street address
Shahid beheshti Blvd.Building number 2
City
Kermanshah
Province
Kermanshah
Postal code
67146673159
Approval date
2019-03-21, 1398/01/01
Ethics committee reference number
IR.KUMS.REC.1398.134
Health conditions studied
1
Description of health condition studied
Irreversible pulpitis
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain
Timepoint
8,16,24 and 48 hour after treatment
Method of measurement
visual analog scale
Secondary outcomes
empty
Intervention groups
1
Description
30 patients received ibuprofen-lysine coated tablets at a dose of 400 mg after treatment.
Category
Treatment - Drugs
2
Description
Control group: 30 patients received gelofen 400 mg with acetaminophen 500 mg after treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Root Therapy, School of Dentistry, Kermanshah University of Medical Sciences
Full name of responsible person
roholah sharifi
Street address
Shariati Street, above Shura Street
City
kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3728 7517
Email
roholahsharifi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid najafi
Street address
shahid beheshti Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 2615 5925
Fax
+98 83 3837 0541
Email
farid_n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
56
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
Kermanshah University of Medical Sciences
Full name of responsible person
Rohola Sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dabir azam Avenue. kosar building
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Fax
+98 83 1722 2400
Email
r.sharifi@kums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Roholla sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shariati avenue
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Fax
+98 83 1722 2400
Email
r.sharifi@kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Roholla sharifi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shariati avenue
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3722 2400
Fax
+98 83 3722 2400
Email
r.sharifi@kums.ac.ir
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 data after Unidentifiable can be potentially publish
When the data will become available and for how long
Start the access period 3 months after printing results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
.
From where data/document is obtainable
dr roholla sharifi
tel:09122177490
imail:r.sharifi@kums.ac.ir
What processes are involved for a request to access data/document