Determination of mean bacterial colonies grown on 4 types of sutures following periodontal surgery in patients with periodontitis
Design
Twelve patients who needed flap treatment were included in the study
Each quadrant underwent flap surgery and one of the 4 types of sutures mentioned was used.One week after surgery, the sutures were removed, placed in buffer tubes, and transported to a laboratory.
The contents of the tubes are grown in culture medium, finally, bacterial colonies associated with each suture were counted.
Settings and conduct
All surgeries were performed by a surgeon at the Ghaedi Dental Clinic in Isfahan.
Participants/Inclusion and exclusion criteria
Patients with periodontitis who require flap surgery in all 4 quadrants
Systemic health;
Taking drugs that affect tissue inflammation
Smoking
Intervention groups
After the periodontal flap surgery, one of the monocryl, monocryl plus, silk or nylon sutures is randomly used for each quadrant.
Main outcome variables
Mean bacterial colonies grown on 4 types of sutures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220101053584N1
Registration date:2022-04-14, 1401/01/25
Registration timing:retrospective
Last update:2022-04-14, 1401/01/25
Update count:0
Registration date
2022-04-14, 1401/01/25
Registrant information
Name
Samaneh Soltani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3772 7171
Email address
s.soltani@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-10, 1395/09/20
Expected recruitment end date
2017-04-21, 1396/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the number of bacterial colonies among four types of sutures following periodontal surgery in patients with periodontics
Public title
Number of bacterial colonies around periodontal sutures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with moderate-to-severe periodontitis requiring periodontal flap surgery in 4 quadrants
Exclusion criteria:
Suffering from systemic diseases (diabetes, cardiovascular diseases, etc.)
Use of anti-inflammatory drugs or any other drugs affecting tissue inflammation
Age
From 20 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
12
More than 1 sample in each individual
Number of samples in each individual:
4
One quadrant
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Only statistical analyzer
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
Isfahan University of Medical Sciences, hezarjarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2016-10-22, 1395/08/01
Ethics committee reference number
395430
Health conditions studied
1
Description of health condition studied
Chronic periodontitis
ICD-10 code
K05.3
ICD-10 code description
Chronic periodontitis
Primary outcomes
1
Description
Average of bacterial colonies grown on sutures
Timepoint
One week after periodontal surgery
Method of measurement
Count of cultured colonies
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Monocryl suture
Category
Treatment - Devices
2
Description
Intervention group: Monocryl plus suture
Category
Treatment - Devices
3
Description
Intervention group: Silk suture
Category
Treatment - Devices
4
Description
Intervention group: Nylon suture
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaedi dental clinic
Full name of responsible person
Narges Naghsh
Street address
Jahan nama Alley, Imam Hossein Square
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3221 0175
Email
n_naghsh@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Naghsh
Street address
Dental school, Isfahan University of Medical sciences, Hezarjarib street,
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
n_naghsh@dnt.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
Narges Naghsh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Periodontics
Street address
dental school, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8007
Email
n_naghsh@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Narges Naghsh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Periodontics
Street address
dental school, Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8007
Email
n_naghsh@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Samaneh Soltani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Dental school, Lavasani street
City
Qom
Province
Ghoum
Postal code
375637185
Phone
+98 25 3772 7171
Email
s.soltani@dnt.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available