Comparison the effect of infiltration injection of dexamethasone and methylprednisolon on post endodontic pain in molars with necrosis pulp
Design
Clinical trial without control group, double blind, Simple random allocation:The computer selects random numbers between 0 and 1 if the random number is <0.5, one goes to group A, and if the random number is> 0.5, then the individual goes to group B.Sample size is 80 people. The trial phase is 2-3
Settings and conduct
This study is done at Yasuj Dental School.
After anesthetic injection, one of the drugs Dexamethasone or methylprednisolone becomes injected, and 6, 12, 24 and 48 hours after the root canal therapy, pain is measured. blindness is performed using the medication sticker, both the patient and the dentist will be unaware of the content of the medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who need endodontic treatment for high and low molar teeth; being at the age of 18-60 years; patients with ASA 1 or 2
; Teeth do not have any periapical lesions.
Non Inclusion criteria:
Patients who have received anti-inflammatory or analgesic medications within the last 8 hours; requiring antibiotic prophylaxis; Having systemic disease which are contraindicated with endodontic treatment; being pregnant or lactating.
Intervention groups
Intervention group 1: injection of dexamethasone (1ml) in bacal vestibule after anesthesia.
Intervention group 2: injection of methylprednisolone (1ml) in bacal vestibule after anesthesia.
Main outcome variables
pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180104038222N1
Registration date:2018-11-02, 1397/08/11
Registration timing:prospective
Last update:2018-11-02, 1397/08/11
Update count:0
Registration date
2018-11-02, 1397/08/11
Registrant information
Name
Sheyda Yeganegiasl
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3333 7286
Email address
sheyda94yeganegi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-06, 1397/08/15
Expected recruitment end date
2018-11-22, 1397/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of infiltration injection of dexamethasone and methylprednisolone on post endodontic pain in molars with necrosis pulp
Public title
The effect of dexamethasone and methylprednisolone on post endodontic pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Required endodontic treatment in upper or lower molar teeth
between 18 and 60 years of age
Patients who are in healthy condition ASA 1 or 2
No periapical pathosis
Exclusion criteria:
Patients who have received anti-inflammatory or analgesic drugs within last 8 hours
Have a periodontal abscess or acute endodontic disease or any periodontal disease
They need antibiotic prophylaxis
Pregnant or lactating
Have mental disabilities
Have systemic disease which are contraindicated with endodontic treatment
Have an acute infection
Sensitivity to Dexamethasone and Methyl Prednisolone
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random allocation using random allocation software:The computer selects random numbers between 0 and 1. If the random number is <0.5, one goes to group A, and if the random number is> 0.5, then the individual goes to group B
.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blindness is done using the medication sticker, and both the patient and the dentist do not know the medication content.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Yasouj University of Medical Sciences
Street address
Shahid Motahari blvd
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2017-12-15, 1396/09/24
Ethics committee reference number
IR.YUMS.REC.1396.136
Health conditions studied
1
Description of health condition studied
Post treatment endodontic pain
ICD-10 code
K08
ICD-10 code description
Other specified disorders of teeth and supporting structures
Primary outcomes
1
Description
Post treatment endodontic pain intensity
Timepoint
level of pain before root canal treatment and after 6,12, 24 and 48 hours
Method of measurement
Heft-parker visual analoug scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Injection of 4 mg per cc dexamethasone in buccal vestibule after anesthetic injection. The drug is made in Iran and from the Alborz Pharmaceuticals Company with the chemical composition of C22H29FO5. The half-life of the drug is 36-54 hours. The severity of pain is recorded at 6, 12, 24, and 48 hours after treatment.
Category
Treatment - Drugs
2
Description
Intervention group 2: injection of 40 mg per cc of methylprednisolone in buccal vestibule after anesthetic injection. The drug is made in Iran and from Caspian Supply Company with chemical composition of C22H30O5. The half-life of the drug is 18-26 hours. The severity of pain is recorded at 6, 12, 24 and 48 hours after treatment
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic affiliated by Yasouj University of Medical Sciences
Full name of responsible person
Mohammad Karim Layeghnejad
Street address
Dental clinic, Shohadaye Haft Ave.
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3322 8274
Email
Mohammad.layegh@yums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Mohammad karim Layegh Nejad
Street address
Shahid Motahari blvd
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3333 7251
Email
Mohammad.layegh@yums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Sheyda Yeganegi Asl
Position
ُStudent
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 8, 4th alley, Ayatollah Kashani Ave
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591931873
Phone
+98 74 3322 8071
Email
Mohammad.layegh@Yums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sheyda Yeganegi Asl
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 8, 4th alley, Ayatollah Kashani Ave
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591931873
Phone
+98 74 3322 8071
Email
Mohammad.layegh@yums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Sheyda Yeganegi Asl
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No. 8, 4th alley, Ayatollah Kashani Ave
City
Yasouj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591931873
Phone
+98 74 3322 8071
Email
Mohammad.layegh@yums.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
Undecided - It is not yet known if there will be a plan to make this available
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