Evaluation of the Bacterial Species and the Mean Number of Bacterial Colonies on Vicryl and Antibacterial Vicryl Sutures Used In Mandibular Third Molar Surgery
this study aims to determine the efficiency of antibacterial vicryl suture in comparison with vicryl suture in the reduction of bacterial colony count and species after surgical extraction of mandibular wisdom teeth.
Design
a double-blinded clinical trial, parallel-group design of 27 self-control participants enrolled between May and July 2019
Settings and conduct
27 patients selected between May and July 2019 among whom in the dentistry faculty of Isfahan university of medical sciences, Isfahan, Iran. After achieving local anesthesia by lidocaine 2% with epinephrine1:80000, a mucoperiosteal flap is elevated and the wisdom tooth is extracted. After that, two interrupted vicryl and antibacterial vicryl sutures are randomly placed in the mesial and distal part of the flap. Location of each suture for each patient is mentioned in patient’s form (i.e. “1M” means vicryl suture in mesial and “2D" means antibacterial vicryl suture in distal) After 1 week, sutures are removed and sent to the microbiological laboratory in less than 1 hour, while protected in saline.
this study of a double-blinded one in which none of the patients, surgeon, and microbiological technician were aware of the exact location of vicryl and antibacterial vicryl sutures.
Participants/Inclusion and exclusion criteria
having mandibular third molar indicated for surgery is the inclusion criteria and any confounding factor for bacterial count and species would be the exclusion criteria.
Intervention groups
After the surgical extraction of the third molar tooth, two interrupted vicryl and antibacterial vicryl sutures are randomly placed in the mesial and distal part of the flap. After 1 week, sutures are removed and sent to the microbiological laboratory.
patients are self-control in this study.
Main outcome variables
type of suture material; predominant bacterial species; count of bacterial colonies
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131205015665N3
Registration date:2020-05-04, 1399/02/15
Registration timing:retrospective
Last update:2020-05-04, 1399/02/15
Update count:0
Registration date
2020-05-04, 1399/02/15
Registrant information
Name
Milad Etemadi-Shalamzari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 1391 3237
Email address
etemadi@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-10, 1398/02/20
Expected recruitment end date
2019-07-11, 1398/04/20
Actual recruitment start date
2019-05-26, 1398/03/05
Actual recruitment end date
2019-07-11, 1398/04/20
Trial completion date
2019-07-11, 1398/04/20
Scientific title
Evaluation of the Bacterial Species and the Mean Number of Bacterial Colonies on Vicryl and Antibacterial Vicryl Sutures Used In Mandibular Third Molar Surgery
Public title
Evaluation of Antibacterial Suture Efficacy on Reduction of Bacterial Adhesion in Impacted Lower Third Molar Surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having type A mesioangular mandibular third molar indicated for surgical removal
having appropriate radiographic imaging
age between 18-30
absence of obvious infection and/or extensive caries lesion in the oral cavity
Exclusion criteria:
systemic health problems
systemic or oral medication affecting normal oral microbial flora and colonization
smoking and drug addiction
alcohol addiction
presence of intraoral inflammation before the surgery
pregnancy and lactation
known or suspected allergy to suture and other materials using in this study
presence of removable prosthesis in the oral cavity
loss of sutures before suture removal appointment
presence of infection after surgery or any other situation with the need for antibiotic therapy
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
30
More than 1 sample in each individual
Number of samples in each individual:
2
one suture will be placed in the distal and the other in the mesial part of the flap which one of them is vicryl (control) and the other is antibacterial vicryl (case)suture.
Actual sample size reached:
27
More than 1 sample in each individual
Actual sample size in each individual:
2
one suture was placed in the distal and the other in the mesial part of the flap which one of them was vicryl (control) and the other was antibacterial vicryl (case)suture.
Randomization (investigator's opinion)
Randomized
Randomization description
pseudorandomization will be done in this study. after considering an ID for each patient number from 1 to 27, in patients with an odd ID number, vicryl suture is placed in the mesial part and antibacterial vicryl suture in the distal part of the flap. in patients with an even ID number, the antibacterial suture is placed in the mesial part of the flap, while the vicryl suture is placed in the distal part.
Blinding (investigator's opinion)
Double blinded
Blinding description
for blinding the participants: they will not be aware of the exact location of the vicryl and vicryl plus sutures in the mesial and distal part of the flap.
for blinding the surgeon: both violet-colored suture materials will be peeled open out of the sight of the surgeon and then given o him for placing the sutures in the mesial and distal part of the flap.
for blinding the technician of the microbiological laboratory: tubes containing the suture materials, will be coded as (1) for vicryl and (2) for vicryl plus .
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan university of medical sciences
Street address
oral and maxillofacial surgery department, dentistry faculty, Isfahan university of medical sciences,Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2019-05-07, 1398/02/17
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.038
Health conditions studied
1
Description of health condition studied
comparison of mean number of bacterial colonies and predominant species on antibacterial vicryl and vicryl sutures
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mean number of bacterial colonies (cfu/ml) on vicryl and antibacterial vicryl suture materials
Timepoint
1 week after surgery
Method of measurement
calculation of mean number of bacterial colonies grown in blood agar culture medium
2
Description
determining the predominant species
Timepoint
1 week after surgery
Method of measurement
gram coloring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: 27 patients selected between May and July 2019 and January 2019 among patients in the dentistry faculty of Isfahan university of medical sciences, Isfahan, Iran. After achieving local anesthesia by lidocaine 2% with epinephrine1:80000, a mucoperiosteal flap is elevated and the third molar tooth is extracted. After that, an interrupted vicryl suture is randomly placed in the mesial or distal part of the flap. Location of each suture for each patient is mentioned in patient’s form (i.e. “1M” means vicryl suture in mesial and “2D" means antibacterial vicryl suture in distal) After 1 week, the suture is removed and sent to the microbiological laboratory in less than 1 hour, while protected in saline. the suture is transferred to the thioglycolate culture media and processed within 1 hour. For each sample, a one-tenth diluted solution with 0.9% NaCl is made and 100µL of it was used on blood agar culture medium and then Incubation is done in 37 degrees of temperature for 2-4 days. Gram coloring is done and cellular morphology is assessed under an optical microscope.
Category
Treatment - Other
2
Description
Intervention group 2: 27 patients selected between May and July 2019 and January 2019 among patients in the dentistry faculty of Isfahan university of medical sciences, Isfahan, Iran. After achieving local anesthesia by lidocaine 2% with epinephrine1:80000, a mucoperiosteal flap is elevated and the third molar tooth is extracted. After that, an interrupted antibacterial vicryl suture is randomly placed in the mesial or distal part of the flap. Location of each suture for each patient is mentioned in patient’s form (i.e. “1M” means vicryl suture in mesial and “2D" means antibacterial vicryl suture in distal) After 1 week, the suture is removed and sent to the microbiological laboratory in less than 1 hour, while protected in saline. the suture is transferred to the thioglycolate culture media and processed within 1 hour. For each sample, a one-tenth diluted solution with 0.9% NaCl is made and 100µL of it was used on blood agar culture medium and then Incubation is done in 37 degrees of temperature for 2-4 days. Gram coloring is done and cellular morphology is assessed under an optical microscope.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Dentistry faculty of Isfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi Shalamzari
Street address
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar--jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5581
Email
etemadi@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo Javanmard
Street address
Vice-chancellor in research affairs, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
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
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi Shalamzari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5581
Email
etemadi@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi Shalamzari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5581
Email
etemadi@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Milad Etemadi Shalamzari
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral and maxillofacial surgery, dentistry faculty, Isfahan university of medical sciences, Hezar-jerib st., Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5581
Email
etemadi@dnt.mui.ac.ir
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
There is no further information
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
study protocol;
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
no other condition
From where data/document is obtainable
sending request email to "sameenrah@gmail.com"
What processes are involved for a request to access data/document
10 days after sending a request to "sameenrah@gmail.com", data will be sent.