compare the prophylactic effects of amitriptyline 25 mg, ibuprofen 400mg and placebo in patients with irreversible pulpitis to control pain and complete anesthetic effects.
Design
Double-blind randomized clinical trial with parallel groups design of 60 adult patients
Settings and conduct
This study was conducted in endodontic ward of Isfahan Dentistry college.Patients were randomly assigned to one of three study groups( similar Capsules were filled with one of medicines: Amitriptyline 25mg,ibuprofen 400 mg and placebo)patients,researcher and health care providers were not aware of type of drugs.Medications were administered as a single dose and at least 60-90 minutes before procedure..pain score were recorded on the Visual Analogue Scale,in different time :before, during and after procedure.
Participants/Inclusion and exclusion criteria
Entry requirements: Age>18 years old,Healthy candidates with no specific systemic diseases,Do not using any analgesic drugs within 4 hours before referral,Diagnosis of irreversible pulpitis based on pulp vitality tests;Non-entry conditions:Using analgesic drugs before refer,Medical allergy to NSAIDs and Amitriptyline,Teeth with a history of trauma and teeth that have recently been endodontically or orthodontically experienced in the last 6 months,Pregnancy and Lactation
Intervention groups
First group:Patients who received Amitriptyline 25mg capsule orally,second group:Patients who received Ibuprofen 400 mg capsule orally.Control group:Patients who received Placebo capsule that include Starch powder
Main outcome variables
Amitriptyline 25mg,ibuprofen 400mg and placebo had same effect on pain control during the endodontics procedure.The type of treated teeth had no effect on drug performance.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181208041882N2
Registration date:2020-07-04, 1399/04/14
Registration timing:retrospective
Last update:2020-07-04, 1399/04/14
Update count:0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
behrooz heydari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3820 8699
Email address
b.heydari@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-11-22, 1397/09/01
Actual recruitment end date
2019-04-09, 1398/01/20
Trial completion date
2019-04-09, 1398/01/20
Scientific title
Evaluation and Comparison the effects of amitriptyline, ibuprofen and placebo in patients with irreversible pulpitis
Public title
Evaluation and Comparison the effects of amitriptyline, ibuprofen and placebo in patients with irreversible pulpitis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy candidates with no specific systemic diseases(specially heart,hepatic and renal diseases)
Do not use any analgesic drugs within 4 hours before referral
Diagnosis of irreversible pulpitis based on pulp vitality tests
Exclusion criteria:
Using analgesic drugs before refer
Medical allergy to NSAIDs and Amitriptyline
Teeth with a history of trauma and teeth that have recently been endodontically or orthodontically experienced in the last 6 months
Pregnancy and Lactation
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study participants, dentists, and researcher unaware of the assigned intervention. Patients in three groups received medications in the same package.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study participants, health care provider and researcher unaware of the assigned intervention. Patients in three groups received medications in the same package.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of yazd university of medical sciences
Street address
shahid sadoughi university of medical science,shohadaye Gomnam Blvd,Alem Sq
City
yazd
Province
Yazd
Postal code
8915173143
Approval date
2018-11-27, 1397/09/06
Ethics committee reference number
IR.SSU.MEDICINE.REC.1397.135
Health conditions studied
1
Description of health condition studied
irreversible pulpitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Reduction in patient pain score
Timepoint
Pain score on presentation,Pain score during injection,Pain score during procedure,Pain score at home(the first 6-8 hours )
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Amitriptyline 25mg, 1 or 2 hours before injecting the Anesthetic drug,patient receive one of the same capsules orally.manufactured by Daru Pakhsh
Category
Treatment - Drugs
2
Description
Intervention group: Ibuprofen 400 mg,1 or 2 hours before injecting the Anesthetic drug,patient receive one of the same capsules orally.manufactured by Raha Pharmaceutical Isfahan
Category
Treatment - Drugs
3
Description
Control group: Placebo,Starch powder,1 or 2 hours before injecting the Anesthetic drug,patient receive one of the same capsules orally
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan University Of Medical Sciences,Dentistry college
Full name of responsible person
Jalil modaresi
Street address
Isfahan University of medical sciences,Hezar jarib Ave,Azadi Sq
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
+98 31 3668 2006
Email
education@mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
مسعود میرزایی
Street address
shahid sadoughi university of medical sciences,shahidan Gomnam Blvd,Alem Sq
City
yazd
Province
Yazd
Postal code
8915173149
Email
b.heydari@ssu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
behrooz heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
shahid sadoughi university of medical sciences,shohadaye Gomnam Blvd,Alem Sq
City
yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
behrooz heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical pharmacy
Street address
shahid sadoughi university of medical sciences,shohadaye Gomnam Blvd,Alem Sq
City
yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Behrooz heydari
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Clinical Pharmacy
Street address
Shahid Sadoughi University of medical sciences,Shohadaye Gomnam Blvd,Alem Sq
City
yazd
Province
Yazd
Postal code
8915173143
Phone
+98 35 3820 3410
Email
b.heydari@ssu.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
After nonrecognition, all data can be share
When the data will become available and for how long
6 months after publication
To whom data/document is available
All of researchers
Under which criteria data/document could be used
Nothing
From where data/document is obtainable
Behrooz Heydari email: b.heydari@ssu.ac.ir
What processes are involved for a request to access data/document
Request your information by email. The data will be sent after a week.