Evaluation of the effects of bromelain and acetaminophen in reduce postoperative pain following root canal therapy with symptomatic irreversible pulpitis in comparision with placebo and acetaminophen
Evaluation of the effect of bromelain in reducing pain in patients after endodontic treatment.
Design
A clinical trial with a control group, with parallel groups, two-way blind, randomized, phase 3 on 60 patients and a random number table was used for randomization.
Settings and conduct
The study is performed in special clinics affiliated with the School of Dentistry of the University of Medical Sciences. 60 patients with two mandibular first molars with irreversible pulpitis are selected. After endodontic treatment, half of the patients will be given placebo and acetaminophen every 6 hours and the other half will be given anaheal and acetaminophen capsules every 6 hours until the patients' pain improves.The VAS system is used to measure pain before endodontic treatment and 24, 12, 6 and 48 hours after endodontic treatment.This study is performed in a double-blind manner.Firstly a pharmacist makes anaheal and acetaminophen tablets with a similar apearance and codes one of them as Aa and the other as Ab.Then, an Aa tablet with an acetaminophen pill will be given to half of the patients and an Ab tablet with an acetaminophen will be given to the other half.
Participants/Inclusion and exclusion criteria
Condition of including: age range of all patients is 10 years and above; tooth periapical tssue is normal
Conditions for not including :pregnant women; patients with liver, kidney and coagulation problems or taking anticoagulants
Intervention groups
The intervention group is given acetaminophen and anaheal and the control group is given acetaminophen and placebo. Then, using the VAS system (visual analog scale),Both groups patients' pain is measured before treatment, 24, 12, 6 and 48 hours after it And finally compared.
Main outcome variables
Pain score after endodontic treatment in a questionnaire including VAS (Visual Analog Scale)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210802052051N1
Registration date:2021-08-29, 1400/06/07
Registration timing:prospective
Last update:2021-08-29, 1400/06/07
Update count:0
Registration date
2021-08-29, 1400/06/07
Registrant information
Name
Fatemeh Abbasi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5514
Email address
f.abbasi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-04, 1400/06/13
Expected recruitment end date
2021-09-26, 1400/07/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effects of bromelain and acetaminophen in reduce postoperative pain following root canal therapy with symptomatic irreversible pulpitis in comparision with placebo and acetaminophen
Public title
Evaluation of the effect of bromelain on pain after root canal treatment
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The age range of all patients be 10 years and older
tooth Periapical tissue be normal
Exclusion criteria:
Pregnant women do not enter the study
Patients who have kidney and coagulation problems
Patients taking anticoagulants
patient has a systemic problem
Age
From 10 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study,a simple randomization method using a table of random number is used.in this study,wich includes 60 samples,the number 00 to 60 are asssigned to the samples.then we randomly select the table point in the row direction.we select numbers smaller than the size of the study population.the select number are the individual code of the community that is selected as the sample.we will continue this until the sample size is complete and reaches the number 60.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is performed in a double-blind manner.Firstly a pharmacist makes anaheal and acetaminophen tablets with a similar apearance and codes one of them as Aa and the other as Ab.
Then, an Aa tablet with an acetaminophen pill will be given to half of the patients and an Ab tablet with an acetaminophen will be given to the other half.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics comittee of Isfahan University of Medical Sciences
Street address
IsfahanUniversity Of Medical Science,Hezar jarib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2021-06-09, 1400/03/19
Ethics committee reference number
IR.MUI.RESEARCH.REC.1400.106
Health conditions studied
1
Description of health condition studied
Pain after root canal therapy
ICD-10 code
K04.0
ICD-10 code description
Pulpitis
Primary outcomes
1
Description
Pain Score in Visual Analog Scale System (VAS)
Timepoint
Before treatment and 6,12,24and 48hours after treatment
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Evaluation of the effecacy of bromelaine in reduce postoperative pain following root canal therapy secondary consequences can be a pain reduction score
Timepoint
To measure pain befor root canal therapy , 6 ,12 ,24 and 48 hours after root canal therapy is used .
Method of measurement
Evaluation of the effecacy of bromelaine in reduce postoperative pain following root canal therapy secondary consequences pain reduction score Visual Analogue Scale can be used .
Intervention groups
1
Description
Control group:Half of the samples receiving acetaminophen 500 mg and placebo every 6 hours until the pain improved and their pain before treatment, 24, 12, 6 and 48 hours after treatment were marked on the VAS (Visual Analogue Scale) questionnaire.
Category
Placebo
2
Description
Intervention group:Half of the samples who receive acetaminophen 500mg and Anaheal 500 mg of Promon Amin health brand every 6 hours until the pain improved and their pain before treatment, 24, 12, 6 and 48 hours after treatment were marked on the VAS (Visual Analogue Scale) questionnaire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental School of Isfahan University of Medical Science
Full name of responsible person
Fatemeh Abbasi
Street address
School of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib St.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Email
f.abbasi@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Isfahan Univercity of Medical Science, Hezar jerib Ave.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 7898
Email
Research@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Abbasi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, Dental research institute, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Fax
Email
f.abbasi@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Abbasi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, Dental research institute, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 5514
Fax
Email
f.abbasi@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Abbasi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of Oral Medicine, Dental research institute, Isfahan University of Medical Sciences, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81774673461
Phone
+98 31 3792 5514
Fax
Email
f.abbasi@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available