Comparison of the effect of local and intramuscular injection of dexamethasone on the amount of mouth opening, pain and swelling following surgical removal of impacted mandibular third molars
Comparison of the effect of local and intramuscular injection of dexamethasone on the amount of mouth opening, pain and swelling following surgical removal of impacted mandibular third molars
Design
In this study, 25 patients referred to dental clinics (facial and maxillofacial surgery) who have similar bilateral impacted third molar are selected. After obtaining written consent about their willingness to participate in the study, they will receive intramuscular and local dexamethasone injection and surgury will done.during and after and in next follow ups measurements will done.
Settings and conduct
this study will be done at OMF department of tabriz dental school.25 patients who have inclusion criteria will be selected and after obtaining consent they will receive intramuscular or local injection and surgury will done. measurements will evaluate in 1st,2nd and 7th days after surgery.
Participants/Inclusion and exclusion criteria
The criteria for entering the study includes the difficulty of surgical process of each side should be equal compared to the other side, the patients should have double-sided impacted third molar teeth and are similar with Paul and Gregory's classification, patient's consent for surgery.
Intervention groups
In these groups, intramuscular or local dexamethasone injection will perform then local anesthesia will perform. after surgical incision and bone removal third molar will extract. Then the tissue will suture with Silk suture 3 O and the patient will discharge. Measurements will taken in the later follow ups.
Main outcome variables
mouth opening؛swelling؛pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180905040955N1
Registration date:2019-05-31, 1398/03/10
Registration timing:registered_while_recruiting
Last update:2019-05-31, 1398/03/10
Update count:0
Registration date
2019-05-31, 1398/03/10
Registrant information
Name
Hamidreza Mohammadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3344 4598
Email address
hamidreza.mohammadi.pajuhan@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-07-21, 1398/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of local and intramuscular injection of dexamethasone on the amount of mouth opening, pain and swelling following surgical removal of impacted mandibular third molars
Public title
Comparison of the effect of local and intramuscular injection of dexamethasone on side effects following surgical removal of impacted mandibular third molars
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
difficulty of surgical process on both side of surgery should be equal
patient's consent for surgery.
patients should have same impacted lower third molars on both side according to pell and gregory category.
Exclusion criteria:
use of drugs that interact with treatment plan
systemic diseases
smoking
pericronitis, infection or pain on the site of surgery
contraindication for use of corticostreoids
recent history of using NSAIDs
patients with GI problems
allergy to NSAIDs
pregnancy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
-
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics committee of tabriz university of medical sciences
Street address
No 69, Mandana street, Golbad street, Tabriz
City
tabriz
Province
East Azarbaijan
Postal code
5715938861
Approval date
2018-07-27, 1397/05/05
Ethics committee reference number
IR.TBZMED.REC.1397.475
Health conditions studied
1
Description of health condition studied
pain,edema and trismus after impacted lower third molar surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
1st day and 3rd day and 7th day after surgery
Method of measurement
visual analogue scale
2
Description
edema
Timepoint
1st day and 3rd day and 7th day after surgery
Method of measurement
flexible ruler
3
Description
mouth opening
Timepoint
1st day and 3rd day and 7th day after surgery
Method of measurement
flexible ruler
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this group, local dexamethasone injection will perform then local anesthesia will perform. after surgical incision and bone removal third molar will extract. Then the tissue will suture with Silk suture 3 O and the patient will discharge. Measurements will taken in the later follow ups.
Category
Treatment - Surgery
2
Description
Intervention group: In this group, intramuscular dexamethasone injection will perform then local anesthesia will perform. after surgical incision and bone removal third molar will extract. Then the tissue will suture with Silk suture 3 O and the patient will discharge. Measurements will taken in the later follow ups.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz dental school
Full name of responsible person
Saeid Nezafati
Street address
Taneshgah str,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5715938861
Phone
+98 44 3344 4598
Email
hamidreza.mohammadi.pajuhan@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saeid Nezafati
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5715938861
Phone
+98 44 3344 4598
Email
hamidreza.mohammadi.pajuhan@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
1
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
Tabriz University of Medical Sciences
Full name of responsible person
Saied Nezafati
Position
professor
Latest degree
Specialist
Other areas of specialty/work
oral and maxillofacial surgery
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5715938861
Phone
+98 44 3344 4598
Email
hamidreza.mohammadi.pajuhan@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saied Nezafati
Position
professor
Latest degree
Specialist
Other areas of specialty/work
oral and maxillofacial surgery
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5715938861
Phone
+98 44 3344 4598
Email
hamidreza.mohammadi.pajuhan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Saied Nezafati
Position
professor
Latest degree
Specialist
Other areas of specialty/work
oral and maxillofacial surgery
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5715938861
Phone
+98 44 3344 4598
Email
hamidreza.mohammadi.pajuhan@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD