Comparison of bacterial colonization in the quality of wound healing following the use of nylon and vicryl sutures in third molar surgeries.
Design
At least 29 people who will use one type of suture on each side of the jaw. Two types of suture will be used in each person and the results of these two sides will be compared. The RAND function of Excel software will be used for randomization.
Settings and conduct
After wisdom tooth surgery, a type of suture is used on each side of the jaw. This study is single blind, because the patient does not know which suture will be inserted on which side of his jaw. 7 days later, the suture will be pulled. Then a part of the suture will be removed. It will be sent to the departments of microbiology and pathology of the university to check the microbial culture and the presence of bacterial colonies and the degree of inflammation around the threads.
Participants/Inclusion and exclusion criteria
The conditions for the study will be: good general health status, without specific systemic diseases or oral diseases and non-smoker.
Exclusion criteria: age older than 35 years old; people with a history of systemic disease and poor health; smoking and alcohol consumption.
Intervention groups
The use of vicryl and nylon sutures in mandibular wisdom teeth surgery in each person. We will not have an intervention or control group. The same treatment method will be applied to all people.
Main outcome variables
The degree of colonization of bacteria - the color of the oral mucosa - the color and consistency of the repair tissue - the amount of pus discharge - the amount of bleeding - the inflammatory reaction of the tissue sample - the presence of bacterial colonies in the tissue sample
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220705055371N1
Registration date:2022-08-19, 1401/05/28
Registration timing:prospective
Last update:2022-08-19, 1401/05/28
Update count:0
Registration date
2022-08-19, 1401/05/28
Registrant information
Name
masome kordinia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3223 5193
Email address
m.kordinia@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-11, 1401/06/20
Expected recruitment end date
2023-05-10, 1402/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of bacterial colonization in the quality of healing following the use of nylon and vicryl suturies in oral surgeries
Public title
Investigating the effect of nylon and vicryl suture on the quality of wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Good general health status
No specific systemic diseases or oral diseases
Non-smoker
Exclusion criteria:
Age older than 35 years old
Poor health
Alcohol consumption
Age
To 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
29
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is done in a simple way and by using the option of generating random numbers on the Kitset.ir site and electronically. unit, candidates for bilateral wisdom tooth surgery. Based on the calculated sample size, random numbers are generated without repetition. Then, according to the generated numbers, a nylon suture thread is placed in the right side of the patient's jaw and in The left side of Vicryl suture thread is used and vice versa for the next number.
Blinding (investigator's opinion)
Single blinded
Blinding description
The surgeon will know the suture used, but the patient does not know that a different suture will be used for him and what type of suture will be used on each side.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University of Medical Sciences
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647745
Approval date
2022-07-04, 1401/04/13
Ethics committee reference number
IR.MUBABOL.REC.1401.052
Health conditions studied
1
Description of health condition studied
Comparison of the colonization of Staphylococcus aureus at the site of nylon and vicryl sutures in third molar surgeries.
ICD-10 code
B95.6
ICD-10 code description
Staphylococcus aureus as the cause of diseases classified elsewhere
2
Description of health condition studied
Comparison of colonization of enterococcus bacteria at the site of nylon and vicryl sutures in third molar surgeries.
ICD-10 code
B95.2
ICD-10 code description
Enterococcus as the cause of diseases classified elsewhere
3
Description of health condition studied
Comparison of colonization of Escherichia coli [E. coli ] bacteria at the site of nylon and vicryl sutures in third molar surgeries.
ICD-10 code
B96.2
ICD-10 code description
Escherichia coli [E. coli ] as the cause of diseases classified elsewhere
4
Description of health condition studied
Comparison of the colonization of Streptococcus mutans at the site of nylon and vicryl sutures in third molar surgeries.
ICD-10 code
B95.4
ICD-10 code description
Other streptococcus as the cause of diseases classified elsewhere
5
Description of health condition studied
Comparison of the colonization of Other and unspecified infectious diseases grown at the site of nylon and vicryl sutures in third molar surgeries.
ICD-10 code
B99
ICD-10 code description
Other and unspecified infectious diseases
Primary outcomes
1
Description
Bacterial colonization rate
Timepoint
At the beginning of the study
Method of measurement
Based on preparation of warm slides and biochemical tests and according to diagnostic tables
2
Description
The color of the oral mucosa
Timepoint
7 days after tooth extraction
Method of measurement
Using the Hilling index modified from the article of Masse et al
3
Description
The color and consistency of the restorative tissue
Timepoint
7 days after tooth extraction
Method of measurement
Using the Hilling index modified from the article of Masse et al
4
Description
The rate of pus discharge
Timepoint
7 days after tooth extraction
Method of measurement
Using the Hilling index modified from the article of Masse et al
5
Description
Bleeding rate
Timepoint
7 days after tooth extraction
Method of measurement
Using the Hilling index modified from the article of Masse et al
6
Description
Inflammatory reaction of tissue sample
Timepoint
7 days after tooth extraction
Method of measurement
Observing the number of inflammatory cells under a microscope with a magnification of *400
7
Description
Presence of bacterial colony in tissue sample
Timepoint
7 days after tooth extraction
Method of measurement
The presence or absence of bacterial colonies under the microscope
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Surgical site sutured with Vicryl suture
Category
Treatment - Surgery
2
Description
Intervention group2: Surgical site with nylon suture
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, Babol University of Medical Sciences
Full name of responsible person
Dr Arezo Javani
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 911 316 1339
Fax
+98 11 3219 0181
Email
m.kordinia@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Dr mehdi rajabnia
Street address
Ganj Afrooz St., Babol University of Medical Sciences
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 911 316 1339
Fax
+98 11 3219 7667
Email
m.kordinia@mubabol.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Babol 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
Babol University of Medical Sciences
Full name of responsible person
Arezo Javani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol University of Medical Sciences, Ganj Afrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3223 5193
Fax
Email
m.kordinia@mubabol.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Arezo Javani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol University of Medical Sciences, Ganj Afrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3223 5193
Fax
Email
m.kordinia@mubabol.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Arezo Javani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Babol University of Medical Sciences, Ganj Afrooz St.
City
Babol
Province
Mazandaran
Postal code
4717647754
Phone
+98 11 3223 5193
Fax
Email
m.kordinia@mubabol.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
Access starts 6 months after the results are published
To whom data/document is available
The data will be accessible to researchers working in academic and scientific institutions and people who are also engaged in industry.
Under which criteria data/document could be used
These data can be used with the intention of using them in medical work and after obtaining permission from the ethics committee and following legal procedures from the university and obtaining permission from the project manager and the research department of Babol Dental School.
From where data/document is obtainable
To receive the desired documents, please send a message to the email below.
khashayarirload@yahoo.com
What processes are involved for a request to access data/document
After receiving the email and obtaining permission from the ethics committee and the research department of Babol University of Medical Sciences, documents or data files will be sent to the applicant.