Comparison of the effect of dexamethasone and prednisolone on complications of bilateral wisdom tooth surgery
Design
This study was without a control group
Phase 1-2 on 16 patients
No parallel group
BlindedT
Settings and conduct
This clinical trial is performed on 16 patients referred to the Oral and Maxillofacial Surgery Department of Ahvaz Jundishapur University, who must be systemically healthy. Patients should have almost identical impacted wisdom teeth in the mandible, which is assessed by panoramic imaging.
Participants/Inclusion and exclusion criteria
Patients with systemic health
Intervention groups
In this study, there is a group receiving two drugs
The first group received 40 mg oral methylprednisolone tablets
The second group received dexamethasone 8 mg oral tablets
Main outcome variables
⦁ Measurement of swelling after impacted wisdom tooth surgery with drug treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211207053314N1
Registration date:2021-12-11, 1400/09/20
Registration timing:prospective
Last update:2021-12-11, 1400/09/20
Update count:0
Registration date
2021-12-11, 1400/09/20
Registrant information
Name
Masoud Hajizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 1374 3422
Email address
hajizadeh.ma@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-05-06, 1401/02/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of dexamethasone and methylprednisolone on complications of wisdom teeth surgery in patients refer to ahvaz dental school
Public title
Comparison of the effect of dexamethasone and methylprednisolone on complications of wisdom teeth surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with systemic health
Exclusion criteria:
Any patient who has a long history of taking aspirin and other medications or corticosteroids
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
16
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ahwaz University of Medical Sciences
Street address
No 7، Bakhshayesh Ave، Fatemi Ave، West Shariati Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6198685353
Approval date
2021-11-23, 1400/09/02
Ethics committee reference number
IR.AJUMS.REC.1400.527
Health conditions studied
1
Description of health condition studied
Comparison of the effect of dexamethasone and methylprednisolone on reducing auction complications
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
⦁ Measurement of swelling after impacted wisdom tooth surgery with drug treatment
Timepoint
1،3،5،7 day
Method of measurement
Nylon thread and millimeter ruler
Secondary outcomes
1
Description
Mouth opening rate
Timepoint
1،3،5،7 day
Method of measurement
collis
Intervention groups
1
Description
Intervention group 1: Prednisolone tablets (40 mg) orally of Abu Reihan company are used 12 hours before and 12 hours after surgery The second intervention group used oral dexamethasone (8 mg) tablets of Abu Reihan company 12 hours before and 12 hours after surgery.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahwaz Dental School
Full name of responsible person
Ershad Hemati
Street address
Dental school، Dey Ave ، Golestan town
City
Ahwaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5170
Fax
+98 61 3320 5320
Email
dental-research@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehdi Ahmadi Moghadam
Street address
Golestan, Valiasr St., Ahvaz University of Medical Sciences
City
َAhwaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Masoud Hajizadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 7، Bakhshayesh Ave، Fatemi Ave، West Shariati Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5170
Email
masoudfmz@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Ershad Hemati
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 4، Pahlavan Ave، Keyanpars Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5170
Email
masoudfmz@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoud Hajizadeh
Position
student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No 7، Bakhshayesh Ave، Fatemi Ave، West Shariati Blvd
City
Ahwaz
Province
Khouzestan
Postal code
6135715775
Phone
+98 61 3320 5170
Email
masoudfmz@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
Undecided - It is not yet known if there will be 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
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
Title and more details about the data/document
Part of the data can be shared
When the data will become available and for how long
Access starts 3 months after the results are published
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
There are no conditions And all colleagues can use all the data
From where data/document is obtainable
Email address
What processes are involved for a request to access data/document
Finally one week after requesting data or documentation