Comparison the prophylactic effect of Indomethacin and Diclofenac Sodium in reducing pain after surgical removal of mandibular horizontal impacted third molar
Comparison of the effect of indomethacin and diclofenac prophylaxis in reducing pain after mandibular horizontal third molar surgery.
Design
Clinical trial with two parallel groups, triple blind, randomized, phase 2 and 3 on 90 patients.
Settings and conduct
The questionnaire form will be given to all people in the study. The information of the first stage of the questionnaire will be completed. This form will include demographic information and, in addition, measure the pain level of the person after third molar tooth surgery. Pain after dental surgery will be recorded by Visual Analogue Scale (VAS) based on the pain ruler. This study will be conducted in Resalat Clinic and Sadaf Clinic of Shahrekord Dental School in 1401.
Participants/Inclusion and exclusion criteria
Inclusion criteria
Patients' satisfaction with participating in the study
Patients aged 18-35 years
mandibular horizontal impacted third molar
Exclusion criteria
Dissatisfaction of patients to continue the study
Those who have used ketorolac
Intervention groups
They will be randomly divided into one of two groups, A and B, using the permutation block method, in one group of the painkiller indomethacin and in the other group, the painkiller diclofenac sodium tablet will be used as a pain prevention drug.
Then, each person will be given one of the two types of drugs of group A or B, 30 minutes before the dental surgery.
Main outcome variables
The group under review
Age
sex
Pain 6 hours after surgery
Pain 12 hours after surgery
Pain 24 hours after surgery
Drug side effects
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221004056088N1
Registration date:2022-10-15, 1401/07/23
Registration timing:registered_while_recruiting
Last update:2022-10-15, 1401/07/23
Update count:0
Registration date
2022-10-15, 1401/07/23
Registrant information
Name
Babak Hasanalizad mazhar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5622 7033
Email address
info@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-08, 1401/07/16
Expected recruitment end date
2022-11-07, 1401/08/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the prophylactic effect of Indomethacin and Diclofenac Sodium in reducing pain after surgical removal of mandibular horizontal impacted third molar
Public title
Comparison the effect of Indomethacin and Diclofenac Sodium in reducing pain after surgical removal of mandibular third molar
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients' satisfaction with participating in the study
Patients' satisfaction with participating in the study
mandibular horizontal impacted third molar
Patients without gastrointestinal ulcer
Not taking painkillers or other drugs for 24 hours before surgery
Not having a history of addiction to drugs or painkillers
Patients who are not pregnant or breastfeeding.
Known insensitivity to common non-steroidal anti-inflammatories and analgesics
No history of nasal polyps, bronchospasm or angioedema caused by non-steroidal anti-inflammatory drugs.
People who are able to take medicine orally.
Exclusion criteria:
Dissatisfaction of patients to continue the study
Those who have used ketorolac
Age
From 18 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Care provider
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
They will be randomly divided into one of two groups, A and B, using the permutation block method, in one group of the painkiller indomethacin (Aria Pharmaceutical Company, Tehran, Iran) (75 mg) ) and in the other group, the painkiller diclofenac sodium tablet (Alborz Pharmaceutical Company, Qazvin, Iran) (100 mg) will be used as a pain prevention drug.
Then, each person will be given one of the two types of drugs of group A or B, 30 minutes before the dental surgery. The study will be conducted in a triple-blind manner
Blinding (investigator's opinion)
Triple blinded
Blinding description
The study will be conducted in a triple-blind manner so that blinding will be established for the maxillofacial specialist doctor, statistical analyst and volunteer patients. The blinding of the specialist doctor is done in such a way that the drugs will be given to the specialist doctor by his assistant, without his knowledge of the type of drug, in the same boxes named with A and B. On the other hand, to blind the patient, he will be told that he will be given one of the two drugs, indomethacin or diclofenac sodium, randomly and without his knowledge of its type. In order to blind the statistical analyst, the information will be provided to him in the form of two groups B and A, where the type of drug in each group is not known, and the result will be checked.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahrekord University of Medical Sciences
Street address
mellate gharbi
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817858935
Approval date
2022-10-04, 1401/07/12
Ethics committee reference number
IR.SKUMS.MED.REC.1401.038
Health conditions studied
1
Description of health condition studied
pain after surgical removal of mandibular horizontal impacted third molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Pain 6 hours after surgery and pain 12 hours after surgery and pain 24 hours after surgery
Method of measurement
The level of pain expressed by patients after horizontal third molar surgery
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group A will use indomethacin tablet painkiller as a pain prevention drug.
Category
Prevention
2
Description
Intervention group: Intervention group B will use the painkiller diclofenac sodium tablet as a pain prevention drug.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Sadaf Clinic, Shahrekord Faculty of Dentistry
Full name of responsible person
Babak Hasanalizadmazhar
Street address
blue square
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817858985
Phone
+98 38 3222 4320
Email
goooolnaz75@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Arsalan Khaledifar
Street address
Rahmatiye
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817853685
Phone
+98 38 3226 0869
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord University of Medical Sciences
Proportion provided by this source
50
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
Shahre-kord University of Medical Sciences
Full name of responsible person
Babak Hasanalizadmazhar
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Elahie
City
Tehran
Province
Tehran
Postal code
2222222222
Phone
.
Email
goooolnaz75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Alireza Tamizifar
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Kashani Avenue
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8817858912
Phone
+98 38 3222 1456
Email
galexy9494@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Babak Hasanalizadmazhar
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Rahmatiye
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
1964814311
Phone
009832224320
Email
goooolnaz75@gmail.com
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