Evaluation of the effects of using dexamethasone impregnated gel foam and local injection of Dexamethasone in reduction of post impacted third molar surgery side effects in patients referring to Bushehr University of Medical Sciences Dental clinic
Comparison of the effects of using dexamethasone-impregnated gelfoam with topical injection of dexamethasone in reducing complications after impacted third molars
Design
A control trial with parallel groups, single blind, randomized, phase 4 on 114 patients was used for randomization from www.randomizer.org
Settings and conduct
A clinical trial consisted of 114 patients referred to Bushehr Dental Clinic with molars in the mandible on each side (right or left). Patients are divided into 3 groups. Each group includes 38 patients. Before starting work, patients take a panoramic radiograph to examine the location of the desired tooth, their angle and in terms of mandibular nerve involvement, and to confirm the inclusion and exit criteria. After silent surgery, it is shortened if necessary and the tissues of the dental follicle are removed. In one group of patients, after surgery, the dexamethasone-impregnated foam gel is placed in silence and sutured. In the second group, after surgery and removal of follicular tissue, the silence is washed with 50 cc of normal saline. After that, it is sutured and finally injected in the trigomandibular space. In the third group (control) after surgery and removal of follicular tissues, the silent is washed with 50cc of normal saline and no corticosteroids, either as injections or gels. Dexamethasone-impregnated foam should not be used.
Participants/Inclusion and exclusion criteria
Age over 18 years and absence of uncontrolled systemic disease and low impacted wisdom teeth with mesio angular angle
Intervention groups
Intervention group 1: Placing dexamethason impregnated gel foam in the extracted socket. Intervention group 2: intramuscular injection of dexamethasone. Intervention group 3: do not inject dexamethasone.
Main outcome variables
Pain; truisms; inflammation; swelling
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201101049209N1
Registration date:2020-11-18, 1399/08/28
Registration timing:prospective
Last update:2020-11-18, 1399/08/28
Update count:0
Registration date
2020-11-18, 1399/08/28
Registrant information
Name
Milad Parvin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3542 8269
Email address
m.parvin@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-10-29, 1399/08/08
Expected recruitment end date
2020-11-28, 1399/09/08
Actual recruitment start date
2020-11-28, 1399/09/08
Actual recruitment end date
2020-11-28, 1399/09/08
Trial completion date
2020-12-19, 1399/09/29
Scientific title
Evaluation of the effects of using dexamethasone impregnated gel foam and local injection of Dexamethasone in reduction of post impacted third molar surgery side effects in patients referring to Bushehr University of Medical Sciences Dental clinic
Public title
Evaluation of the effects of using Dexamethasone impregnated gel foam and local injection of Dexamethasone in reduction of post impacted third molar surgery side effects in patients referring to Bushehr University of Medical Sciences Dental clinic
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Third molar of mandible(mesioangular)
No pericoronitis
Absence of uncontrolled systemic disease
Age older than 18 years old
Exclusion criteria:
Presence of peicoronitis
Presence of uncontrolld systemic disease
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
114
Actual sample size reached:
114
Randomization (investigator's opinion)
Randomized
Randomization description
114 patients from Patients referred to the Oral and Maxillofacial Surgery Department of Bushehr Dental Clinic Using Random Allocation Based random number from the randomizer.org website will fall into three groups
Blinding (investigator's opinion)
Double blinded
Blinding description
The participant, outcome assessor, and data analyst have no knowledge of the type of intervention performed.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences, Salman Farsi St.
City
Bushehr
Province
Boushehr
Postal code
7518759577
Approval date
2020-10-27, 1399/08/06
Ethics committee reference number
IR.BPUMS.REC.1399.117
Health conditions studied
1
Description of health condition studied
Post opreative pain
ICD-10 code
K08.8
ICD-10 code description
Other specified disorders of teeth and supporting structures
2
Description of health condition studied
Trismus
ICD-10 code
R25.2
ICD-10 code description
Cramp and spasm
Primary outcomes
1
Description
Patients' pain
Timepoint
Baseline, 2 hours after surgery, 6 hours after surgery, 24 hours after surgery, 72 hours after surgery, and finally 7 days after surgery
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Trismus
Timepoint
Baseline, before surgery, after surgery and on the first, third and seventh days.
Method of measurement
Measuring the distance between the incisal edge at the opening of the mouth and with a caliper device in millimeters
Intervention groups
1
Description
Intervention group: Receive dexamethasone by injection into the trygmandibular space
Category
Treatment - Drugs
2
Description
Intervention group: Placement of dexamethasone-impregnated gelfoam
Category
Treatment - Drugs
3
Description
Control group: Do not take dexamethasone
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental clinic of Bushehr
Full name of responsible person
Nima Kamgar
Street address
Kuy-e-Bandar, Moallem St
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
ّFatemeh Dehghan Azad
Street address
Imam Khomeini St., in front of Bahman movie theater
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
10
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
Boushehr University of Medical Sciences
Full name of responsible person
Mohsen Salehi
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Kuy-e-Bandar, Moallem St.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Milad Parvin
Position
Dentist
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Kuy-e-Bandar, Moallem St.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Mohsen Salehi
Position
ُُُStudent
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Kuy-e-Bandar, Moallem St.
City
Bushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
m.parvin@bpums.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
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
All data can be shared after individuals are unidentified
When the data will become available and for how long
Access period is from the publication of the dissertation to 1 year after the publication of the dissertation
To whom data/document is available
Anyone can access the data.
Under which criteria data/document could be used
This data can be used for further research, provided the source is mentioned
From where data/document is obtainable
Vice Chancellor for Research, Bushehr University of Medical Sciences
What processes are involved for a request to access data/document