comparison of the effect of Vicryl plus suture material on the accumulation of Enterococcus and E.coli microorganisms on adjacent silk sutures with different distances
Design
clinical trial with control group; four parallel group in 20 patient; double blind; randomized
Settings and conduct
surgical area is randomly divided into four sites, which one vicryl plus suture and three silk sutures at dictance of three, six and nine millimeters of vicryl plus will be placed in it. One week after the surgery, the sutures will be separated and placed in a BHI transfer suspension and transmitted to the microbiological laboratory within twelve hours.Then microorganisms will be cultivate to the specific culture medium of each bacteria from the fluid transfer medium. After culture on the media and placing the culture plate in an incubator at 37 ° C for twenty-four hours, the growth of the bacteria will be checked and the number of colonies (CFU units) will be counted
Participants/Inclusion and exclusion criteria
patients who indicated implant surgery of two adjacent implants, constitute the statistical population of the study.
patients with periodontal disease, systemic diseases, or taking other medicines will be excluded from the study
Intervention groups
First intervention group: Use silk suture at a distance of nine millimeters of vicryl plus suture
Second intervention group: Use silk suture at a distance of nine millimeters of vicryl plus suture
Third intervention group: Use silk suture at a distance of nine millimeters of vicryl plus suture
Control group: use of Vicryl plus suture that is multi-strand and contains Triclosan as an antimicrobial material
Main outcome variables
accumulation of bacteria on surgical sutures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180714040460N3
Registration date:2019-01-26, 1397/11/06
Registration timing:registered_while_recruiting
Last update:2019-01-26, 1397/11/06
Update count:0
Registration date
2019-01-26, 1397/11/06
Registrant information
Name
Nima Nadafpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
n_nadaf@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-02-04, 1397/11/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Vicryl plus suture material on the accumulation of Enterococcus and E.coli microorganisms on adjacent silk sutures
Public title
Accumulation of oral microorganisms around the suture materials in implant surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who have indication for implant surgury in at least two adjacent implant sites
Exclusion criteria:
to have periodontal diseases
to have systemic diseases
to take other medicines
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
4
very patient has four suture materials in his mouth as sample
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
After implantation, the surgeon uses four sutures with similar sequences in all patients and one week after surgery, sutures will be delivered to the microbiologist as numerical codes so microbiologist an patient don’t know the type of sutures
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of central organization of Islamic Azad university
Street address
No. 4, Neyestan 10, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2018-05-27, 1397/03/06
Ethics committee reference number
IR.IAU.DENTAL.REC.1397.007
Health conditions studied
1
Description of health condition studied
surgical site infection around surgical suture materials
ICD-10 code
A48.8
ICD-10 code description
Other specified bacterial diseases
Primary outcomes
1
Description
accumulation of bacteria on surgical sutures
Timepoint
counting colony forming units after bacterial culture on culture medium
Method of measurement
counts of colonies with naked eye
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Use silk suture at a distance of nine millimeters of vicryl plus suture
Category
Prevention
2
Description
Intervention group: Use silk suture at a distance of six millimeters of vicryl plus suture
Category
Prevention
3
Description
Intervention group: Use silk suture at a distance of three millimeters of vicryl plus suture
Category
Prevention
4
Description
Control group: use of Vicryl plus suture that is multi-strand and contains Triclosan as an antimicrobial material
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Private office of Dr.Nima Naddaf Pour
Full name of responsible person
Nima Naddaf Pour
Street address
Unit.24 , No.38 , Juy pa alley , Sarv cross , Paknejad blvd , Saadat Aabad town
City
Tehran
Province
Tehran
Postal code
1998798331
Phone
+98 21 2676 7768
Email
n_nadaf@dentaliau.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ardavan Etemadi
Street address
No. 4, Neyestan 10, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4570
Email
a-etemadi@farabi.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Nima Nadafpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit.24 , No.38 , Juy pa alley , Sarv cross , Paknejad blvd , Saadat Aabad Town
City
Tehran
Province
Tehran
Postal code
1998798331
Phone
+98 21 2676 7768
Fax
Email
n_nadaf@dentaliau.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nima Nadafpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit.24 , No.38 , Juy pa alley , Sarv cross , Paknejad blvd , Saadat Aabad Town
City
Tehran
Province
Tehran
Postal code
1998798331
Phone
+98 21 2676 7768
Fax
Email
n_nadaf@dentaliau.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nima Nadafpour
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Unit.24 , No.38 , Juy pa alley , Sarv cross , Paknejad blvd , Saadat Aabad Town
City
Tehran
Province
Tehran
Postal code
1998798331
Phone
+98 21 2676 7768
Fax
Email
n_nadaf@dentaliau.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 more information with respect to the subject