Comparison of the effect of meloxicam with ibuprofen on the duration of analgesia after mandibular impacted third molar surgery
Design
Clinical trial with parallel, double-blind, randomized groups, phase 3 on 15 patients
Settings and conduct
The study was performed in the surgery department of the School of Dentistry of the Islamic Azad University and a private office and the patient and the researcher and examiner were kept blind.
Participants/Inclusion and exclusion criteria
Age range 17 to 35 years
Having bilateral impcted wisdom teeth
Absence of systemic disease
Absence of inflammation
Intervention groups
Half an hour to an hour before the start of surgery, the patient was randomly given Meloxicam and Profane once.
Main outcome variables
Duration of analgesia after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170307032929N3
Registration date:2020-09-18, 1399/06/28
Registration timing:retrospective
Last update:2020-09-18, 1399/06/28
Update count:0
Registration date
2020-09-18, 1399/06/28
Registrant information
Name
Fina Navi
Name of organization / entity
Islamic Azad University Tehran Dental Branch
Country
Iran (Islamic Republic of)
Phone
+98 912 201 5179
Email address
f_navi@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2020-04-09, 1399/01/21
Actual recruitment start date
2019-10-23, 1398/08/01
Actual recruitment end date
2020-08-12, 1399/05/22
Trial completion date
2020-08-12, 1399/05/22
Scientific title
Comparison of the Effectiveness of Meloxicam and Profen in duration of analgesia after mandibular impacted third molar surgery
Public title
Effect of Meloxicam and Profen in analgesia after mandibular impacted third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age range of 17 to 35
Requires bilatral surgery of mandibular impacted third molar
Exclusion criteria:
Acute or chronic inflammation
Taking other medications
Pregnancy
Contraindication of study drugs for patient
Systemic problems
Age
From 17 years old to 35 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
15
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The mandibular quadrants were divided into case and control groups, and one of the two test pills was randomly given to each individual during two visits for surgery on each side of the mandible.
In each sample, meloxicam and profen were given one by one. In this way, if in the first patient we gave meloxicam for the left surgery, in the second patient we gave meloxicam for the right surgery.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study was performed on 15 people in the age range of 17 to 35 years with complete satisfaction. They were informed that two approved painkillers were being used. The surgeon, examiner, and patient were not aware of the name of the drug, and the drug was taken out of the coded box by the assistant and given to the patient. The amount of pain was noted on a piece of paper during the hours specified by the patient.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran Islamic Azad University of Medical Sciences
Street address
Unit 3،No. 23، Abbasi Alley،Shahran Ave، Tehran Town
City
Tehran
Province
Tehran
Postal code
1478676641
Approval date
2019-07-14, 1398/04/23
Ethics committee reference number
IR.IAU.DENTAL.REC.1398.030
Health conditions studied
1
Description of health condition studied
Removal of impacted mandibular third molar
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Duration of analgesia
Timepoint
The patient is given medicine half an hour before the start of surgery and the pain is recorded 2, 4, 6, 10, 15 hours after the surgery.
Method of measurement
In the study of the effect of meloxicam and profen on duration of analgesia after mandibular impacted third molar surgery, the method of measuring the variable can be visual analog scale.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient was randomly given a 15 mg Meloxicam tablet half an hour before the start of surgery, and the patients were told they can use an volatile drug such as acetaminophen if they had severe pain so in this group that use volatile dug our study would end.
Category
Treatment - Surgery
2
Description
Control group: The patient was randomly given a 400 mg Profen tablet half an hour before the start of surgery, and the patients were told they can use an volatile drug such as acetaminophen if they had severe pain so in this group that use volatile dug our study would end
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Islamc Azad University of Medical Science Dental Branch Faculty of dentistry-Department os Su
Full name of responsible person
Shima Naderkhani
Street address
No. 23, Abbasi Alley, Shahran Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1478676641
Phone
+98 21 4431 1450
Email
www.naderkhani.shima@gmail.com
2
Recruitment center
Name of recruitment center
4th Floor, Karoon Building, West Bolvar Ferdos Ave , Tehran
Full name of responsible person
Shima Naderkhani
Street address
No. 23, Abbasi Alley, Shahran Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1478676641
Email
www.naderkhani.shima@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Islamic Azad University, Tehran Dental Branch
Full name of responsible person
Arash Azizi
Street address
No. 9, Pasdaran St., 9th Neyestan, Tehran Town
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
drarashazizi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research, Islamic Azad University, Tehran Dental Branch
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fina Navi
Position
Oral and Maxillofacial surgeon
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.9 ,9th Neyestan, Pasdaran St, Tehran Town
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
f_navi@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shima Naderkhani
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 23, Abbasi Alley, Shahran Ave, Tehran Town
City
Tehran
Province
Tehran
Postal code
1478676641
Phone
+98 21 4431 1450
Email
www.naderkhani.shima@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shima Naderkhani
Position
Dentistry Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No. 23, Abbasi Alley, Shahran Ave
City
Tehran
Province
Tehran
Postal code
1478676641
Phone
+98 21 4431 1450
Email
www.naderkhani.shima@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
Participants' data file, consent form, number one and two information form, research method, statistical analysis and related tables will be shared.
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions will also be available, as well as people working in industry
Under which criteria data/document could be used
Access to information forms is only possible for researchers in this field
From where data/document is obtainable
Reasearcher Ms.Shima Naderkhani, contact number: 09128509183, address: No. 23, Abbasi Alley, Shahran Ave, Tehran Town Email: www.naderkhani.shima@gmail.com
What processes are involved for a request to access data/document
Request by email and the result will be commiunicated to them as soon as possible