Evaluating the effect of celecoxib in comparison with acetaminophen on pain management after insertion of first orthodontic wire: a randomized, double-blind, controlled trial
Determining the effectiveness of celecoxib compared to acetaminophen in controlling pain after placing the first orthodontic wire
Design
A parallel-group, double-blind, randomized clinical trial on 70 patients after receiving the first orthodontic wire.
Settings and conduct
To check the level of pain in patients in both groups, a visual analog scale (VAS) was given to the patients to record their pain level at specified times.
At the end, the obtained information will be compared with each other, then the results will be analyzed statistically.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Age 12 to 30 years
2- Treatment plan: fixed orthodontics without tooth extraction
3- According to little's irregularity index, it has a moderate rating
4- Starting orthodontic treatment with the lower jaw
Exit criteria:
1- Taking antibiotics and painkillers before orthodontic treatment
2-Pregnant and lactating women
3-Patients with a history of drug allergy
4- Patients with a history of gastrointestinal or kidney ulcer and liver or cardiovascular failure
5- History of drug addiction
6- Not having written informed consent
7. Have periodontal disease
Intervention groups
1. The group that was prescribed celecoxib 200 mg 1 hour before and 6 hours after receiving the orthodontic wire.
2. The group that was prescribed 500 mg of acetaminophen 1 hour before and 6 hours after receiving the orthodontic wire.
Main outcome variables
pain control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221109056454N1
Registration date:2023-11-21, 1402/08/30
Registration timing:prospective
Last update:2023-11-21, 1402/08/30
Update count:0
Registration date
2023-11-21, 1402/08/30
Registrant information
Name
Sara Ghasemzadeh Soroush
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8823 0329
Email address
s-ghsoroush@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effect of celecoxib in comparison with acetaminophen on pain management after insertion of first orthodontic wire: a randomized, double-blind, controlled trial
Public title
Evaluating the effect of celecoxib in comparison with acetaminophen on orthodontic pain management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patient's age is between 12 and 30 years
The treatment plan for orthodontic patients should be fixed without tooth extraction.
According to little's irregularity index, they should have a moderate rating.
Orthodontic treatment should start with the lower jaw.
Exclusion criteria:
Taking antibiotics and painkillers before orthodontic treatment
Pregnant and lactating women
Patients with history of allergy to celecoxib or acetaminophen
Patients with a history of gastrointestinal or kidney ulcer and liver or cardiovascular failure
History of drug addiction
Not having written informed consent to participate in the study
Patients with periodontal disease
Age
From 12 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization of patients into two groups under study will be done by permutation block method with size 2x35. The list of random numbers will be prepared by the thesis statistics advisor and will be provided to pharmacist. The website https://www.sealedenvelope.com will be used to generate the list of random numbers. In order to conceal the allocation, the drugs (Celecoxib and Acetaminophen) with the same weight, appearance, color are prepared in identically packaged containers and are coded according to a list of random numbers and assigned to each patient who enters the study sequentially. is allocated and the drug container receives the corresponding code.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study will be double-blind and the statistician will be blind and does not know about the groups under study. Also, the patient will be blind and does not know what medicine he is taking. But in this study, there is no need to blind the dentist because he has no role in evaluating and measuring the outcome of the study and it is the patient who self-reports using the VAS index to measure pain at the considered times. Because in this study and in general, in the placement of orthodontic wire, the same brand of wire (which is American Orthodontics (AO)) is an important issue, and the performance of the clinician in this case will not be influential or confusing.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Dentistry- Tehran University of Medical Sciences
Street address
Tehran- Quds town (west)- between South Flamak and Zarafshan, Simai Iran street- Central headquarters of the Ministry of Health, Treatment and Medical Education, block A, 13th floor
City
Tehran
Province
Tehran
Postal code
1467664961
Approval date
2023-10-21, 1402/07/29
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1402.070
Health conditions studied
1
Description of health condition studied
Pain after placing the first orthodontic wire
ICD-10 code
Z46.4
ICD-10 code description
Encounter for fitting and adjustment of orthodontic device
Primary outcomes
1
Description
Overall pain score
Timepoint
2 hours after wire placement, 6 hours after that, the first night of wire placement, 24 hours after the start, and finally on the second, third, and seventh day.
Method of measurement
The patient's score on the severity of orthodontic pain in the general state with the VAS index
2
Description
Pain score in chewing mode
Timepoint
2 hours after wire placement, 6 hours after that, the first night of wire placement, 24 hours after the start, and finally on the second, third, and seventh day.
Method of measurement
Patient's score of orthodontic pain severity in chewing state with VAS index
3
Description
Pain score in biting position
Timepoint
2 hours after wire placement, 6 hours after that, the first night of wire placement, 24 hours after the start, and finally on the second, third, and seventh day.
Method of measurement
Patient score of orthodontic pain severity in biting state with VAS index
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The group that was prescribed celecoxib 200 mg 1 hour before and 6 hours after receiving the orthodontic wire.
Category
Treatment - Drugs
2
Description
Intervention group: The group that was prescribed 500 mg of acetaminophen 1 hour before and 6 hours after receiving the orthodontic wire.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran University of Medical Sciences Faculty of Dentistry
Full name of responsible person
Atefeh Saffar Shahroudi
Street address
At the end of North Kargar Street, next to the Atomic Energy Organization, before the exit of Hakim Sharq Highway, Faculty of Dentistry, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
14399-55991
Phone
+98 21 8801 5801
Email
dentistry@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Tabasom Houshmand
Street address
North Karegar St,Tehran-Iran
City
Tehran
Province
Tehran
Postal code
14399-55991
Phone
+98 21 8801 5801
Email
sch-dentistry@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefeh Saffar Shahroudi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dr. Shahroudi's office, 1st floor, unit 2, Afra Building, , Itsar St., corner of Mehr Alley, Marzdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1464643114
Phone
+98 21 4426 9453
Email
a-shahroudi@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Atefeh Saffar Shahroudi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontic specialist
Street address
Dr. Shahroudi's office, 1st floor, unit 2, Afra Building, , Itsar St., corner of Mehr Alley, Marzdaran Blvd.
City
Tehran
Province
Tehran
Postal code
1464643114
Phone
+98 21 4426 9453
Email
a-shahroudi@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Ghasemzadeh Soroush
Position
DDS student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Unit 10, No. 2, Second Alley, North Sarsabz St., Marzdaran Blvd
City
Tehran
Province
Tehran
Postal code
1464813671
Phone
+98 21 8823 0329
Email
sarasoroosh20@gmail.com
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 non-personally identifiable information
When the data will become available and for how long
6 months after the results are published
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
In order to familiarize with the type of study for similar studies and judging
From where data/document is obtainable
Project manager, Dr. Atefeh Safar Shahroudi
a-shahroudi@tums.ac.ir
What processes are involved for a request to access data/document
Details of the requesting person and the relevant organization, the reason for the request and the process to be carried out