(1) Objectives: Decreasing pain and swelling after wisdom tooth surgery. (2) Designs: In this study, 34 patients of Tabriz faculty of dentistry will be chosen and routine wisdom tooth surgery will be done for both of their lower wisdom teeth. (3) Setting and conduct: Case side will be chosen randomly. All surgeries will be done by the same surgeon under same circumstances. (4) Participants including major eligibility criteria: Patients with bilateral impacted lower third molars of same position will be included. Patients with systemic disease will be excluded. (5) Intervention: After the operation, Barton bandage will be used for one side. Bandage won’t be used for the other side. (6) Main outcome measures (variables): Patients will be examined 48 hours after surgery. Pain would be measured one and two days after surgery. Depending on the pain severity 0 to 3 would be documented. Swelling co efficient would be measured by determining tragus- mouth corner and gonion – lateral canthus distances before and after surgery.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2012092510935N1
Registration date:2013-02-16, 1391/11/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-02-16, 1391/11/28
Registrant information
Name
Mohammad Ali Ghavimi
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 6147
Email address
ghmd@irimc.org
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2011-03-20, 1389/12/29
Expected recruitment end date
2012-03-19, 1390/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the pressure bandage use in varying the pain and swelling after lower third molar surgery.
Public title
The effect of the pressure bandage use in varying the pain and swelling after lower third molar surgery.
Purpose
Prevention
Inclusion/Exclusion criteria
Major Inclusion criteria: Having bilateral impacted third molars; Having impacted third molars in the same position.
Major Exclusion criteria: Systemic diseases; bone diseases
Age
From 18 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
1
Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz university of medical sciences
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
5166414766
Approval date
2012-07-30, 1391/05/09
Ethics committee reference number
9173
Health conditions studied
1
Description of health condition studied
Swelling
ICD-10 code
R60
ICD-10 code description
Oedema, not elsewhere classified
2
Description of health condition studied
Pain
ICD-10 code
R52.9
ICD-10 code description
Pain, unspecified
Primary outcomes
1
Description
Swelling
Timepoint
Before and 48 hours after surgery
Method of measurement
Millimeters by meterstick
Secondary outcomes
1
Description
Pain
Timepoint
24 and 48 hours after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention: Using Barton bandage that is a kind of pressure bandage during 24 hours after surgery of one side impacted wisdom tooth.
Category
Prevention
2
Description
Control: Not using Barton bandage after surgery of the other side impacted wisdom tooth.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of dentistry, Tabriz university of medical sciences
Full name of responsible person
Mohammad Ali Ghavimi
Street address
Golgasht St, Azadi Ave
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences vice chancellor for research
Full name of responsible person
Seyed Kazem Shakouri
Street address
Golgasht St, Azadi Ave
City
Tabriz
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 vice chancellor for research
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
Tabriz university of medical sciences
Full name of responsible person
Mohammad Ali Ghavimi
Position
Assistant professor
Other areas of specialty/work
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
Iran
Phone
+98 41 1553 6078
Fax
Email
m_ghavimi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mohammad Ali Ghavimi
Position
Assistant professor
Other areas of specialty/work
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
Iran
Phone
+98 41 1553 6078
Fax
Email
m_ghavimi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Mohammd Ali Ghavimi
Position
Assistant professor
Other areas of specialty/work
Street address
Golgasht St, Azadi Ave
City
Tabriz
Postal code
Iran
Phone
+98 41 1553 6078
Fax
Email
m_ghavimi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)