Comparison of newly Presented Suturing technique with Conventional Suturing on Severity of Complications Following Mandibular fully Impacted third molar Surgery
The innovative suture technique with conventional suture during mandibular fully impacted third molar surgery on the severity of postoperative complications will compare
Design
Controlled clinical trial with a parallel group, double blinded, randomized with statistical software using blocks of six
Settings and conduct
This study carried out in department of Surgery, Faculty of Dentistry, Semnan University of Medical Sciences The suture pattern will be selected randomly in the first surgery and will not be shown to the surgeon prior to the start of suturing and finishing the surgical procedure. The patient and measurer will be blind about the type of suture
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients aged between 20 and 30
Both-sided and symmetrical impaction of mandibular third molar tooth that are classified in the same class by Pell & Gregory
Meeting ASA1 systemic conditions
Collaborative patients with frequent visits for follow-up
Patients without periodontal disease
The exclusion criteria of the study include:
Pathologic lesion in the impacted tooth
Difference in follicle size around the crown of each person's sides
Taking steroids, drugs, alcohol, contraceptives
Pregnancy and lactation
History of delayed wound healing
Failure to complete follow-up sessions
Intervention groups
In the control side simple loop suture.In the case side, first the thread will be twisted around the needle holder in clockwise direction
A)Then, with the aid of the needle holder the middle of the loose thread is taken and passed around the needle holder through the twisted thread to form a loop
B)The needle holder is passed through the loop into the free end of the thread and pulled to complete the knot
Main outcome variables
Pain؛ maximal؛ oral opening rate؛ facial swelling؛ the 7th tooth distal pocket depth؛ clinical attachment loss in 7th tooth distal؛ dry sockt؛ dehiscence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181021041404N1
Registration date:2018-11-14, 1397/08/23
Registration timing:registered_while_recruiting
Last update:2018-11-14, 1397/08/23
Update count:0
Registration date
2018-11-14, 1397/08/23
Registrant information
Name
MohammadHosein Mansourian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 4780
Email address
mh.mansourian95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-07, 1397/08/16
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of newly Presented Suturing technique with Conventional Suturing on Severity of Complications Following Mandibular fully Impacted third molar Surgery
Public title
Comparison of Innovative Suture with Conventional Suture on Severity of Complications Following Mandibular fully Impacted third molar Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both-sided and symmetrical impaction of mandibular third molar tooth that are classified in the same class by Pell & Gregory
Meeting ASA1 systemic conditions
Non-smokers patients
Collaborative patients with frequent visits for follow up
Patients without periodontal disease
patients with proper oral hygiene
patients aged between 20 and 30
Exclusion criteria:
Pathologic lesion in the impacted tooth
Difference in follicle size around the crown of each person's sides
Surgical time exceeding 25 minutes
More than 5 minutes of surgical difference on both sides
Taking steroids, drugs, alcohol, contraceptives
Pregnancy and lactation
History of delayed wound healing
Failure to complete follow up sessions
Age
From 20 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
More than 1 sample in each individual
Number of samples in each individual:
2
Right and left mandibular fully impacted third molar
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize, patients are divided into two groups using the blocks of six that made by statistical software:
In the first group, the first surgery is on the lower right jaw, and in the second group, the first surgery is performed on the lower left jaw. All surgeries will be performed by an oral and maxillofacial surgeon and in one room with an assistant. The suture pattern will be selected randomly in the first surgery and will not be shown to the surgeon prior to the start of suturing and finishing the surgical procedure.
Blinding (investigator's opinion)
Double blinded
Blinding description
The suture pattern will not be shown to the surgeon(main researcher) prior to the start of suturing and finishing the surgical procedure. The patient and measurer will be blind about the type of suture.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
Vice chancellor for research, Setad building, Basij Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Approval date
2018-10-17, 1397/07/25
Ethics committee reference number
IR.SEMUMS.REC.1397.157
Health conditions studied
1
Description of health condition studied
Mandibular fully impacted third molar surgery
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
2
Description of health condition studied
Postoperative facial swelling after mandibular fully impacted third molar surgery
ICD-10 code
R22.9
ICD-10 code description
Localized swelling, mass and lump, unspecified
3
Description of health condition studied
Trismus after mandibular fully impacted third molar surgery
ICD-10 code
S03.4
ICD-10 code description
Sprain of jaw
4
Description of health condition studied
Dehiscence after mandibular fully impacted third molar surgery
ICD-10 code
T81.31
ICD-10 code description
Disruption of external operation (surgical) wound, not elsewhere classified
5
Description of health condition studied
Dry socket after mandibular fully impacted third molar surgery
ICD-10 code
K10.3
ICD-10 code description
Alveolitis of jaws
Primary outcomes
1
Description
pain
Timepoint
Before starting surgery, it is assessed that there is no pain at the surgical site.pain of the patient 12 hours after surgery and on days 7, 1, 2, 3, 4, 5, 6 after surgery will be measured.
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Swelling
Timepoint
Before starting surgery, 24 hours after surgery and the days 3rd and 7th after surgery
Method of measurement
Facial width will be measured by ticking three facial distances on a thread and then measuring it by a ruler. Horizontal: The distance between the corners of the lip to the attachment of the ear lobe on same side and the thread is subject to the cheeks. Vertical: The distance between the outer eye cantos and the mandibular angle of the same side and the thread is subject to the cheeks. Oblique: The distance from the corners of the lip and the mandibular angle of the same side and the thread is subject to the possible facial swelling (post-operative swelling)
2
Description
Maximal oral opening rate
Timepoint
Before starting surgery, 24 hours after surgery and the days 3rd and 7th after surgery
Method of measurement
It will be calculated by measuring the distance between the central margin of the upper jaw and the central edge of the lower jaw (or left in the absence of the right central) by the digital caliper (Mitutoyo, Illinois, USA).
3
Description
Dry socket
Timepoint
24 hours after surgery and the days 3rd and 7th after surgery
Method of measurement
Blums criteria
4
Description
Dehiscence
Timepoint
24 hours after surgery and the days 3rd and 7th after surgery
Method of measurement
The self-opening of sutures without patient’s intervention that define with observations
5
Description
Clinical attachment loss in 7th tooth distal
Timepoint
Before starting surgery, six months after surgery
Method of measurement
The distance between CEJ and the pocket bottom will be measured by william probe (Juya Instruments PVT, Tehran, Iran)
6
Description
The 7th tooth distal pocket depth
Timepoint
Before starting surgery, six months after surgery
Method of measurement
The distance between the gingival margin and pocket bottom will be measured by the william probe (Juya Instruments PVT, Tehran, Iran)
Intervention groups
1
Description
Intervention group:first the thread will be twisted around the needle holder in clockwise direction A)Then, with the aid of the needle holder the middle of the loose thread is taken and passed around the needle holder through the twisted thread to form a loop B)The needle holder is passed through the loop into the free end of the thread and pulled to complete the knot C)same process is repeated for the second time
Category
Treatment - Surgery
2
Description
Control group:A suture will be made on the releasing incision and two sutures will be implemented on 7th tooth distal and mesial papillae with a common knot.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Dental School
Full name of responsible person
Mohammad Esmaeelnejad
Street address
Faculty of Dentistry, Semnan University of Medical Sciences, Hefdah Shahrivar St., Saadi Square
City
Semnan
Province
Semnan
Postal code
3519-99951
Phone
+98 23 3333 4657
Email
Esaeelnejad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research center of Semnan Dental School
Full name of responsible person
Dr. Nazila Ameli
Street address
Research center, Semnan Dental School, 17 Shahrivar Blvd
City
Semnan
Province
Semnan
Postal code
35198-99951
Phone
+98 23 3333 4657
Email
Esmaeelnejad@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?