The aim of this study is to compare the effect of Sling and Single interrupted suture on pain, swelling, trismus, dehiscence, probing pocket depth & clinical attachment loss of adjacent second molars after extraction of impacted & semi-impacted mandibular third molars. The study design is randomized clinical trial in a parallel method. The included population is 18 patients who candidates for surgical extraction of mandibular third molars with bilaterally identical level of impaction. Patients with bilaterally different level of impaction & tissue coverage patients with systemic disease or any inflammation and periodontal disease will be excluded from the study. The sample size will be 36 bilateral surgical extractions in two suture group (each group 18 surgery). Bilateral operation will be done under local anesthesia by the same surgeon to prepare the triangular flap and minimum ostectomy in both sides. After removal of the tooth, the distal surface of the flap will be closed with sling suture technique in one side (group1) and single interrupted suture technique in the other side (group2). Suture technique for each side will be randomized & patients will be unaware. All patients will do same postoperative instruction. Clinical examination will be evaluated immediate, 2, 7& 14 days after operation. Probing pocket depth & clinical attachment level will be recorded after 22 weeks by one student.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017100436551N1
Registration date:2017-11-11, 1396/08/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-11-11, 1396/08/20
Registrant information
Name
Farzad Aghdashi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2230 4904
Email address
aghdashi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2017-10-12, 1396/07/20
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Sling and Single interrupted suture on post-operation complications after extraction of impacted mandibular third molars
Public title
Influence of Sling suture on post-operation complications after extraction of mandibular third molars
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria:patients who have mandibular third molars with bilaterally identical level of impaction. age 18<<25 years; nonsmoker; no systemic diseases; no pregnancy or lactation; no medication in the last 6 months ; no inflammation, such as acute pericoronitis or periodontal disease, in the oral cavity.
exclusion criteria: patients whose level of impaction & tissue coverage are not bilaterally symmetrical,age >25 years; smokers; patients with systemic disease; pregnancy or lactation period;use medication in the last 6 months;any inflammation such as acute pericoronitis and periodontal disease
Age
From 18 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
randomization will be done by flipping a coin.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Sciences
Street address
Velenjak, Daneshju Blv
City
Tehran
Postal code
Approval date
2017-10-23, 1396/08/01
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.523
Health conditions studied
1
Description of health condition studied
complication of third molar surgery
ICD-10 code
T88.9
ICD-10 code description
complication of surgical and medical care, unspecified
single interrupted suture: is used to approximate
the buccal and lingual flaps. The needle penetrates the outer surface of the first flap.The under surface of the opposite flap is engaged, and, the suture is brought back to the initial side, the knot is tied
Category
Treatment - Surgery
2
Description
Sling suture:The needle engages the outer surface of the flap and,encircles the tooth. The outer surface of the same flap of the adjacent inter dental area is engaged.The suture is returned to the initial site, and the knot is tied.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry Faculty of Shahid Seheshti University of Medical Science
Full name of responsible person
Dr. Seyed Farzad Aghdashi
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Ghazi Tabatabaie Clinic
Full name of responsible person
Dr. Seyed Farzad Aghdashi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Investigator
Full name of responsible person
Dr. Seyed Farzad Aghdashi
Street address
Velenjak, Daneshju Blv.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Investigator
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Farzad Aghdashi
Position
Oral and maxillofacial surgery
Other areas of specialty/work
Street address
Velenjak, Daneshju Blv
City
Tehran
Postal code
Phone
+98 21 2230 4904
Fax
Email
dr.aghdashi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Farzad Aghdashi
Position
Oral and maxillofacial surgeon
Other areas of specialty/work
Street address
Velenjak, Daneshju Blv
City
Tehran
Postal code
Phone
+98 21 2230 4904
Fax
Email
dr.aghdashi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nasrin Roohandeh
Position
Student
Other areas of specialty/work
Street address
City
Tehran
Postal code
Phone
Fax
Email
nassrin.rhnd.93@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)