Protocol summary

Study aim
The evaluation of the local dexamethasone effect on reducing pain and swelling to local use into third molar socket in mandibular impacted third molar surgery on patients referred to the Special Clinic of Shiraz Dental School.
Design
Clinical trial with control group, with parallel groups, random allocation using binary block division, double blind, second phase on 30 patients, the random allocation procedure is determined by the statistical consultant.
Settings and conduct
In this study, a clinical trial is performed on the patients referred to the Special Clinic of Shiraz Dental School and the patients are 18 to 30 years old who have bilateral mesioangular impacted third molar with similar clinical and radiographic condition after obtaining informed consent, randomly enter the study. In first tooth surgery, gelfoam impregnated with half vial of 4 gram dexamethasone Zahravi Pharmaceutical Company and in second surgery performed one week after the first surgery, gelfoam without dexamethasone is inserted into the socket of the extracted tooth and the area is sutured. 1, 3 and 10 days later, the swelling is measured with a white paper tape from the tragus to the corner of the lip and pain is measured by Visual Analog Scale Questionnaire. The patient and the person who measures pain and swelling are blinded in the study.
Participants/Inclusion and exclusion criteria
Participants: The patients with no immune system problems, with bilateral impacted mandibular third molars and age-group 18 to 30 years old. Participants not allowed: The patients with immune system problems, infection and aphthous after surgery.
Intervention groups
Immediately after surgery on both sides, randomly one side with dexamethasone-impregnated gelfoam and the other side are placed with gelfoam without dexamethasone.
Main outcome variables
Pain and swelling are assessed 1, 3 and 10 days later.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220117053746N1
Registration date: 2022-04-09, 1401/01/20
Registration timing: retrospective

Last update: 2022-04-09, 1401/01/20
Update count: 0
Registration date
2022-04-09, 1401/01/20
Registrant information
Name
farhad ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 3193
Email address
ghorbanif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-19, 1400/11/30
Expected recruitment end date
2022-03-21, 1401/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Evaluation of the Local Effect of Dexamethasone on Reducing Pain and Swelling after Impacted Third Molar Surgery
Public title
The Evaluation of the Local Effect of Dexamethasone on Reducing Pain and Swelling after Impacted Third Molar Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No immune system problems Having third molar tooth located on both sides of mandible
Exclusion criteria:
Somebody has immune system problems Infection or aphthous in the mouth after surgery
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
The patient and the person who measures pain and swelling after treatment do not know what kind of treatment has been performed.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz Dental School, Ghasrodasht Street
City
Shiraz
Province
Fars
Postal code
7184836165
Approval date
2022-01-05, 1400/10/15
Ethics committee reference number
IR.SUMS.DENTAL.REC.1400.123

Health conditions studied

1

Description of health condition studied
Impacted Third Molar
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The amount of pain and swelling
Timepoint
1, 3 and 10 days later
Method of measurement
Pain based on VAS in range of 0 to 10 and swelling based on a white paper tape from the tragus to the corner of the lip are measured.

Secondary outcomes

1

Description
Pain
Timepoint
1, 3 and 10 days later
Method of measurement
Pain is measured by Visual Analog Scale Questionnaire.

2

Description
Swelling
Timepoint
1, 3 and 10 days later
Method of measurement
Swelling is measured with a white paper tape from the tragus to the corner of the lip.

Intervention groups

1

Description
Intervention Group: In one side, impregnated gelfoam with half of 4-gram vial of dexamethasone made in Zahravi Pharmaceutical Company is put inside the socket of extracted and impacted tooth.
Category
Treatment - Drugs

2

Description
Control Group: On the other side, gelfoam without dexamethasone is put inside the extracted and impacted tooth.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Dental School
Full name of responsible person
Farhad Ghorbani
Street address
Shiraz Dental School, Ghasrodasht Street
City
Shiraz
Province
Fars
Postal code
7184836165
Phone
+98 71 3626 3193
Email
Ghorbanif@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farhad Ghorbani
Street address
Shiraz Dental School, Ghasrodasht Street
City
Shiraz
Province
Fars
Postal code
7184836165
Phone
+98 71 3626 3193
Email
Ghorbanif@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Farhad Ghorbani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht Street
City
Shiraz
Province
Fars
Postal code
7184836165
Phone
+98 71 3626 3193
Email
Ghorbanif@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farhad Ghorbani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht Street
City
Shiraz
Province
Fars
Postal code
7184836165
Phone
+98 71 3626 3193
Email
Ghorbanif@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farhad Ghorbani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz Dental School, Ghasrodasht Street
City
Shiraz
Province
Fars
Postal code
7184836165
Phone
+98 71 3626 3193
Email
Ghorbanif@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
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