Comparison between the effects of dexamethasone and betamethasone on decreasing the complications after the surgical extraction of mandibular impacted third molars
The aim of this clinical trial is to compare the efficacy of dexamethasone and betamethasone on reducing complications after impacted mandibular third molar surgery. Inclusion criteria includes: third mandibular molar impaction classification referred to Pell and Gregory (Class II III) and the same difficulty of the surgery on both sides. Exclusion criteria includes: systemic disease; presence of pericoronitis infection or pain before surgery; steroid contraindication and recent history of inflammatory non-steroidal drug use.
Twenty adult patients of both genders who have bilateral impacted third molars with similar situations and are referred to Oral and Maxillofacial Department, will be chosen.
Dexamethasone or betamethasone is injected in the vestibule at the site of surgery in the first operation. Next appointment will be held at least two weeks later, which the other drug is injected in the same manner after the surgery.
Pain is assessed on 2nd and 7th day after the surgery using Visual Analog Scaling.
Swelling is measured by facial reference point from tragus to the lip commissural and measurement of trismus is performed by using the inter incisor distance before, 2 and 7 days after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201312093750N4
Registration date:2014-01-20, 1392/10/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-01-20, 1392/10/30
Registrant information
Name
Bahman Derakhshan
Name of organization / entity
International Campus, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 1149
Email address
dbahmand@irimc.org
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-09-08, 1392/06/17
Expected recruitment end date
2013-12-08, 1392/09/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between the effects of dexamethasone and betamethasone on decreasing the complications after the surgical extraction of mandibular impacted third molars
Public title
Effect of dexamethasone and betamethasone on decreasing the complications after the surgical extraction of mandibular impacted third molars
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age between 15 and 30 years; Pell and Gregory classification (class II or III); Equivalent degree of surgical difficulty comparing one side with the other.
Exclusion criteria: Use of medication that could interfere with the healing process; Systemic disease; Pericoronitis ,infection or pain at the time of operation; Contraindications for using steroids; Recent history of non-steroidalanti inflammatory drug use; pregnant woman
Age
From 15 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Both patient and the person who performs the measurments are blinded from the corticosteroid used in each surgery. None of the surgoun and the assistant will perform the assessments.
The randomization of the groups is done using 4-row blocks.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th floor, Central University Building, Ghods Ave, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2013-09-07, 1392/06/16
Ethics committee reference number
1193/130/د/92
Health conditions studied
1
Description of health condition studied
mandibular impacted third molar
ICD-10 code
K01.1
ICD-10 code description
Primary outcomes
1
Description
Pain
Timepoint
2nd and 7th day after intervention
Method of measurement
Visual analogue scale
2
Description
Maximum mouth opening
Timepoint
Before and 2 and 7 days after the intervention
Method of measurement
Ruler
3
Description
Swelling
Timepoint
Before and 2 and 7 days after intervention
Method of measurement
Paper strip
Secondary outcomes
empty
Intervention groups
1
Description
Infiltrate injection of betamethasone (4 mg) corticosteroids at the buccal vestibule around the site of surgery
Category
Treatment - Drugs
2
Description
Infiltrate injection of dexamethasone (8 mg) corticosteroids at the buccal vestibule around the site of surgery
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
International Campus, School Of Dentistry ,Tehran University of Medical Sciences
Full name of responsible person
Dr. Bahman Derakhshan
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Sayed Jalal Pourhashemi
Street address
School of Dentistry, Mahan Blvd, Khani-Abad No
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
International Campus, School Of Dentistry ,Tehran University of Medical Sciences
Full name of responsible person
Dr.Bahman Derakhshan
Position
Faculty member/ Assistant professor
Other areas of specialty/work
Street address
School of Dentistry, Mahan Blvd, Khani-Abad No
City
Tehran
Postal code
Phone
+98 21 5585 1151
Fax
+98 21 5585 1141
Email
b-derakhshan@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
International Campus, School Of Dentistry ,Tehran University of Medical Sciences
Full name of responsible person
Dr. Bahman Derakhshan
Position
Faculty member/Assistant Professor
Other areas of specialty/work
Street address
School of Dentistry, Mahan Blvd, Khani-Abad No
City
Tehran
Postal code
Phone
+98 21 5585 1151
Fax
Email
b-derakhshan@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)