What is the difference between topical and oral ibuprofen in pain control in terms of pain intensity and duration of analgesia?
Design
Clinical trial, randomized to 20 patients
Settings and conduct
Department of Surgery, School of Dentistry, Islamic Azad University. Divided into 2 groups of 10 people.
In the first group, the patient is placed in a semi-supine position. After anesthesia, incision, and removal of the flap with a surgical milling, some of the bone covering the tooth is removed and after the tooth section and extraction. The area is rinsed, then the ibuprofen 400mg tablet is divided into several parts and placed with gelfoam as a carrier of ibuprofen inside the extracted tooth socket.
Second group: The second group is given ibuprofen 400 mg orally 20 minutes before impacted wisdom tooth surgery.
Participants/Inclusion and exclusion criteria
Be in the age range of 18 to 35 and have the indication for surgery to extract the wisdom tooth of the mandible. Systemic disease for exclusion.
Intervention groups
Intervention group: Evaluation of the effectiveness of topical ibuprofen on reducing pain after impacted wisdom tooth surgery
Control group: Evaluation of the effectiveness of oral ibuprofen on reducing pain after impacted wisdom tooth surgery
Main outcome variables
Pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210501051150N1
Registration date:2021-05-31, 1400/03/10
Registration timing:prospective
Last update:2021-05-31, 1400/03/10
Update count:0
Registration date
2021-05-31, 1400/03/10
Registrant information
Name
Fatemeh Azimifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2206 9849
Email address
arbehnaz@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-15, 1400/03/25
Expected recruitment end date
2021-10-02, 1400/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of topical and oral ibuprofen on pain relief after mandibular third incisor surgery
Public title
The effect of topical and oral ibuprofen on pain relief
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Indications for surgical extraction of mandibular wisdom teeth
Exclusion criteria:
systemic disease
Age
From 18 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, use a simple random dedicated method to help the computer. In this method, a list of numbers from 1 to 20 is prepared. Randomly lists this list called numbers. Depending on the time of your entry into the surgical department of the School of Dentistry, another of these numbers is assigned to the patient and based on the list in the list is available to the intervention group (subject that ibuprofen is associated with jelfoam) and the control group (group that ibuprofen Produces food) is allocated.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
In one group, oral ibuprofen is used and in the other group, topical ibuprofen is used with the same condition as the patients.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of AZAD University of dental Sciences
Street address
Aseman12 shargi , paknezhad, و saadat abad ,
City
tehran
Province
Tehran
Postal code
1998181887
Approval date
2021-01-27, 1399/11/08
Ethics committee reference number
IR.IAU.DENTAL.REC.1399.266
Health conditions studied
1
Description of health condition studied
Impacted tooth
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain intensity
Timepoint
Measurement of pain before the intervention and up to 12 hours after the intervention.
Method of measurement
visual analogue scale for pain
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After surgery and extraction of the impacted wisdom tooth, ibuprofen has divided 400 mg into several parts and put it with gelfoam in socket.
Category
Treatment - Other
2
Description
Control group: Ibuprofen 400 mm is given orally to patients 20 minutes before surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
University Hospital Azad Islamic
Full name of responsible person
Fatemeh Azimi Fard
Street address
Tehran Province, Tehran, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arbehnaz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
DR. Arash Azizi
Street address
No. 9, Pasdaran St., 9th Neystan
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arbehnaz@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Hossein Tafzali Shadpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 9, Pasdaran St., 9th Neystan
City
Tehran
Province
Tehran
Postal code
1946853314
Phone
+98 21 2256 4571
Email
arbehnaz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Azimi Fard
Position
Dentist
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Aseman12 shargi , Paknezhad, و Saadat abad
City
Tehran
Province
Tehran
Postal code
1998181887
Phone
009822069849
Email
arbehnaz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Azimifard
Position
Dentist
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Aseman12 shargi , Paknejad, و Saadat abad
City
Tehran
Province
Tehran
Postal code
1998181887
Phone
+98 21 2206 9849
Email
arbehnaz@yahoo.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
Upon completion of the study, confidential information such as patient details, etc. will be deleted and other information will be provided to researchers.
When the data will become available and for how long
One year
To whom data/document is available
All dentist student
Under which criteria data/document could be used
Information on the outcome and pain pressure can be distributed in this study
From where data/document is obtainable
1. Library of the School of Dentistry of Tehran Azad University
Phone 02122006660
Postal Code 1916393813
2. fatemeh.azimifard@gmail.com
3.arbehnaz@yahoo.com
What processes are involved for a request to access data/document
1. An official request or a letter from the library of the School of Dentistry of the Azad University can use all the information as soon as possible.
2. The request can be accessed through the mentioned e-mail address within ten days fatemeh.azimifard@gmail.com