Investigating the clinical effect of injectable and local dexamethasone on the complications after surgery of the impacted third molar of the mandible.
Design
After the plan is approved by the university research council and the code of ethics is obtained, the patients who meet the conditions to participate in the study will be selected. First randomization will be done and then people will be randomly divided into 3 groups. The study will be double-blinded.
Settings and conduct
surgery will be performed by a maxillofacial surgeon. The follow-up of the patients and the recording of their complications will be done by the final year dental student
Participants/Inclusion and exclusion criteria
1. Age between 17 and 35 years
2. Having personal consent
3. Having a mesioangular 3rd molar in the mandible
4. Not using antibiotics in the last three weeks
Intervention groups
I. The first group, the group that will receive only painkiller (400 mg ibuprofen) after surgery (control group).
II. The second group, the group that will receive the injectable form of dexamethasone in addition to painkillers (400 mg ibuprofen) (experimental group).
III. The third group, the group that will receive the topical form of dexamethasone in addition to painkillers (400 mg ibuprofen) (experimental group).
Main outcome variables
The maximum opening of the mouth will be checked by measuring the distance between the incisal edge of the central teeth with a ruler. This measurement will be repeated before surgery, 48 hours after surgery, and 7 days after surgery.
visual analogue scale (VAS) will be used to measure pain. In addition, the number of pills used is also effective in measuring the pain level of patients. The amount of swelling will be measured clinically, from the tragus of the ear to the outer corner of the mouth on the surgical side by a tape adjusted to the natural concavity of the patient's face.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230802059009N1
Registration date:2023-10-26, 1402/08/04
Registration timing:retrospective
Last update:2023-10-26, 1402/08/04
Update count:0
Registration date
2023-10-26, 1402/08/04
Registrant information
Name
Soheil Soltani koohbanani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3870 0528
Email address
soheil.soltani2016@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Clinical Effect of Injectable and Topical Dexamethasone on Complications After Mandibular Third Molar Surgery- A Clinical Study
Public title
Comparison of the effect of injectable and topical dexamethasone on dental surgery complications
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
age of 17 to 35
personal informed consent
having mesioangular impacted 3rd molar in the mandible
not having a history of antibiotic consumption over the last 3 weeks
Exclusion criteria:
systemic diseases such as diabetes or blood pressure
Being allergic to dexamethasone
Having pericoronitis or infection
pregnancy
drug consumption
Age
From 17 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random block method will be used to assign samples to groups. Blocks will be considered as 3 blocks. Group type selection for each person will be done through the following site.
www.sealedenvelope.com/simple-randomiser/v1/lists
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is double-blinded, and the surgeon and the researcher will not know about the patient groups. Only one person (student) who administers anesthetic and corticosteroid injection will be aware of the group of patients. The surgeon and the person who follows up the patients and records their pain and swelling levels will not know about the patient group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Moallem avenue
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Approval date
2023-03-14, 1401/12/23
Ethics committee reference number
IR.MAZUMS.REC.1401.539
Health conditions studied
1
Description of health condition studied
impacted third molars
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Swelling
Timepoint
before surgery, 2 days, and 7 days after surgery
Method of measurement
The amount of swelling will be measured clinically, from the tragus of the ear to the outer corner of the mouth on the surgical side by a tape adjusted to the natural concavity of the patient's face.
2
Description
trismus
Timepoint
before surgery, 2 days, and 7 days after surgery
Method of measurement
The maximum opening of the mouth will be checked by measuring the distance between the incisal edge of the central teeth with a ruler.
3
Description
pain after wisdom tooth surgery
Timepoint
before surgery, 2 days, and 7 days after surgery
Method of measurement
visual analogue scale (VAS) will be used to measure pain. In addition, the number of pills used is also effective in measuring the pain level of patients.
Secondary outcomes
empty
Intervention groups
1
Description
Control group: This group only receives painkillers (400 mg ibuprofen) after surgery. Patients are advised to use this painkiller every 8 hours if they feel any pain
Category
Treatment - Drugs
2
Description
Intervention group 1: In this group, after surgery, 2 ml of dexamethasone 8 mg (Daro Pasha, Tehran, Iran) will be injected into the medial pterygoid muscle with a 24-gauge syringe, and ibuprofen 400 mg will be prescribed.
Category
Treatment - Drugs
3
Description
Intervention group 2: In this group, after the surgery, 10 mg of dexamethasone sodium phosphate powder (Daro Pasha, Tehran, Iran) will be gradually placed in the socket of the extracted tooth, and 400 mg ibuprofen pain reliever will also be prescribed.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
tooba dental clinic
Full name of responsible person
Dr. Amirhossein Pakravan
Street address
moallem avenue
City
sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Email
soheil.soltani2016@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Pakravan
Street address
Moallem avenue
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Email
soheil.soltani2016@yahoo.com
Grant name
Research Deputy of Mazandaran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Soheil Soltani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Moallem avenue
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Email
soheil.soltani2016@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Amirhossein Moaddabi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Moallem avenue
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Email
a.moaddabi2@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Soheil Soltani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Moallem avenue
City
Sari
Province
Mazandaran
Postal code
۳۳۹۷۱-۴۸۱۵۷
Phone
+98 11 3304 4000
Email
soheil.soltani2016@yahoo.com
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
Undecided - It is not yet known if there will be 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