The aim of this study is to evaluate pain and swelling after extraction of impacted mandibular third molar in two different types of suturing. Inclusion criteria are: having the same degree of impaction in both mandibular third molars; age between 15 to 25 years; nonsmoker; no systemic disease; no pregnancy or lactation; no medication taken in the last 6 months that could influence wound healing after surgery; no inflammation; absence of pain on the impacted molar region.
14 cases who meet the inclusion criteria are selected from the referred patients to the oral and maxillofacial surgery department of School of Dentistry, Tehran University of Medical Sciences, International Campus.
In this split mouth technique study, after surgical removal of both mandibular third molars, reflected flap is turned back to its place and sutured in a figure of eight technique and on the other side reverse figure of eight technique is used to close the flap.
Facial measurements from tragus to the lip commissure is used for horizontal swelling, and from lateral cantus to the mandibular angle for vertical swelling and are recorded just before and 7 days after surgery. Severity of pain is assessed by a VAS questionnaire and is filled by the patient on day 7 post operation.
Scince both type of sutures are regularly used in wound closure, there is no special suture related complication for the patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311263750N1
Registration date:2014-01-11, 1392/10/21
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-01-11, 1392/10/21
Registrant information
Name
Bahman Derakhshan
Name of organization / entity
International Campus, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5585 1149
Email address
dbahmand@irimc.org
Recruitment status
Recruitment complete
Funding source
International Campus, Tehran University of Medical Sciences
Expected recruitment start date
2013-11-24, 1392/09/03
Expected recruitment end date
2014-01-23, 1392/11/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of pain and swelling after extraction of impacted mandibular third molar in two different types of suturing.
Public title
Evaluation of pain and swelling after extraction of impacted mandibular third molar in two different types of suturing.
Purpose
Treatment
Inclusion/Exclusion criteria
Age between 15 to 25 years; nonsmoker; no systemic disease and to be in good general health; no pregnancy or lactation; no medication in the last 6 months that could influence wound healing after surgery; no inflammation, such as acute pericoronitis or periodontal disease, in the oral cavity and without any pain on the impacted molar region
Age
From 15 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
14
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients are randomly divided into two groups by flipping a coin. Suturing technique of reverse figure of eight is compared to figure of eight technique as the control group.
Patients and the observer are blinded to the suture design.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
6th floor, Ghods Ave., Central University Bulding, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2013-11-23, 1392/09/02
Ethics committee reference number
92/D/130/1910
Health conditions studied
1
Description of health condition studied
Mandibular Impacted 3rd Molar
ICD-10 code
K01.1
ICD-10 code description
An impacted tooth is a tooth that has failed to erupt because of obstruction by another tooth.
Primary outcomes
1
Description
Pain
Timepoint
Days 0 and 7
Method of measurement
Visual Analog Scale
2
Description
Vertical Swelling
Timepoint
Days 0 and 7
Method of measurement
Paper strip (mm)
3
Description
Horizontal Swelling
Timepoint
Days 0 and 7
Method of measurement
Paper strip (mm)
Secondary outcomes
empty
Intervention groups
1
Description
Suturing technique of reverse figure of eight is compared to figure of eight technique as the control group
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
International Campus, Tehran University of Medical Sciences
Full name of responsible person
Dr. Bahman Derakhshan
Street address
School Of Dentistry, Mahan Blvd, Khani Abad No
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Seyed Jalal Pourhashemi
Street address
School of Dentistry, Mahan Blvd, Khani-Abad No
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
International Campus, Tehran University of Medical Sciences
Full name of responsible person
Dr.Bahman Derakhshan
Position
Faculty member/ Assistant professor
Other areas of specialty/work
Street address
School of Dentistry, Mahan Blvd, Khani-Abad No
City
Tehran
Postal code
Phone
+98 21 5585 1149
Fax
Email
b-derakhshan@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
International Campus, Tehran University of Medical Sciences
Full name of responsible person
Dr. Bahman Derakhshan
Position
Faculty member/Assistant Professor
Other areas of specialty/work
Street address
School of Dentistry, Mahan Blvd, Khani-Abad No
City
Tehran
Postal code
Phone
+98 21 5585 1149
Fax
Email
b-derakhshan@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
International Campus, Tehran University of Medical Sciences
Full name of responsible person
Dr. Bahman Derakhshan
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
b-derakhshan@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)