1.Comparison of pain intensity in surgery and extraction of wisdom tooth between injectable betamethasone group and oral betamethasone
2.Comparison of swelling intensity in surgery and extraction of wisdom tooth between injectable betamethasone group and oral betamethasone
3.Comparison of Trismus Severity in Surgery and Wisdom Tooth Extraction in Injectable Betamethasone and Oral Betamethasone
Design
The randomized double-blinded clinical trial
Settings and conduct
24 patients referred to the Tabriz dental school with the third molar in a similar situation and with the same degree of difficulty are included in the study and randomly divided into two groups of 12 people.Before having the surgery, in the first group betamethasone will be injected to the Vestbol and in second group, 2 mg oral betamethasone was taken.
The severity of pain is measured 6 hours, day 1 and 3 after surgery.Trismus determined by measuring the maximum opening of the mouth and inflation is specified as tragus reference points to the corner of the lips at 48 hours and 7 days after surgery
Participants/Inclusion and exclusion criteria
Entry criteria :
1. Age limit is between 18 to 35 years old
2. The symmetric presence of impacted third molars in two directions of lower jaw
3. The difficulty level of one side surgery is equal comparing to the other side
Exit criteria:
1-Usage of drugs that can interfere the treatment process
2-Having the systemic diseases
3-Existence of perryonitis or infection or pain during operation
4-Contraindications to steroids
5-Recent use of non-steroidal inflammatory drugs
6-Pregnancy
Intervention groups
Injectable betamethasone group and oral betamethasone group
Main outcome variables
injectable betamethasone/oral betamethasone; time of pain (Pain is measured 6,24 and 36 hours after surgery); Pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180117038415N2
Registration date:2018-08-31, 1397/06/09
Registration timing:retrospective
Last update:2018-08-31, 1397/06/09
Update count:0
Registration date
2018-08-31, 1397/06/09
Registrant information
Name
Ali Mortazavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5965
Email address
mortazavia@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-15, 1397/03/25
Expected recruitment end date
2018-08-16, 1397/05/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of injectable betamethasone with oral betamethasone in mandibular wisdom teeth surgery.
Public title
Comparing the effect of injectable betamethasone with oral betamethasone in mandibular wisdom teeth surgery.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age limit is between 18 to 35 years old
The symmetric presence of impacted third molars in two directions of lower jaw
The difficulty level of one side surgery is equal comparing to the other side
Exclusion criteria:
Usage of drugs that can interfere the treatment process
Having the systemic diseases
Existence of pericronite or infection or pain during operation
Contraindications to steroids
Recent use of non-steroidal inflammatory drugs
Pregnancy
Age
From 18 years old to 35 years old
Gender
Both
Phase
2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
24
More than 1 sample in each individual
Number of samples in each individual:
2
impacted third molar of mandible
Randomization (investigator's opinion)
Randomized
Randomization description
Referring patients to Tabriz Faculty Of Dentistry for mandibular wisdom teeth surgery from 15/06/2018 to 16/082018 are numbered, after observing the entry and exit requirements of the study. Then, using a random number table, we select 24 numbers from this table and enter the subject.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the participating patients and physician will be informed of the type of treatment intervention (1- Injectable betamethasone or 2-Oral betamethasone), however, the evaluator of the results will not be aware of the intervention method, so the study will be single-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166615953
Approval date
2018-08-06, 1397/05/15
Ethics committee reference number
IR.TBZMED.REC.1397.380
Health conditions studied
1
Description of health condition studied
Impacted wisdom teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Pain intensity
Timepoint
6,24 and 36 hours after surgery
Method of measurement
Visual Analogue Scale
2
Description
Inflation
Timepoint
48 hours , 7 days
Method of measurement
tragus reference points to the corner of the lips
3
Description
Trismus
Timepoint
48 hours , 7 days
Method of measurement
The maximum opening of the mouth
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Injection of 2 mg betamethasone to the Vestbol before having the surgery
Category
Treatment - Drugs
2
Description
Second intervention group: Consumption of 2 mg oral betamethasone before having the surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, IRAN
Full name of responsible person
Ali Mortazavi
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem Jouyban
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Mortazavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Mortazavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Mortazavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Golgasht Ave, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
mortazavia@tbzmed.ac.ir
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The data obtained from the participants, including the pain intensity , inflation and Trismus of these individuals, can be presented in the form of a table. The protocol for the study, which is routine methods, has no problems with its publication. Statistical analysis can also be provided. In this study, an informed consent form will be used that can be published without mentioning the person's name and personal details. A clinical study report can be made after the necessary analyzes.
When the data will become available and for how long
Start the access period 9 months after publishing the results
To whom data/document is available
For researchers in Dental school of Tabriz University
Under which criteria data/document could be used
For scholars working in other academic and academic institutions, if approved by the project implementer
From where data/document is obtainable
Dr. Ali Mortazavi, email or phone
Dental school of Tabriz University, Oral & Maxillofacial Surgery Department
9143175166 0098 ، aliweb001@gmail.com
What processes are involved for a request to access data/document
After receiving the request will be answered within a week.