Comparison of the effect of four suture materials on the accumulation of Enterococcus and E.coli microorganisms in patients undergoing dental implant surgery
comparison of the effect of Vicryl Plus, Vicryl, Silk and Nylon sutures on the accumulation of Enterococcus and E.coli microorganisms in patients undergoing Implant Surgery
Design
randomized clinical trial; no cotrol group; single blind
Settings and conduct
surgical area (including the space required to place two adjacent implants) is randomly divided into four sites, and each suture materials including vicryl, vicrtyl plus , silk and Nylon will be placed in each surgical site at a distance of three millimeters from the adjacent suture. One week after the patient's surgery, the sutures will be separated and placed in a brain heart infusion (BHI) transfer suspension, which all aerobic and anaerobic microorganisms can grow, 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 by a sterilized loop. 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 colony forming units (CFU) will be counted. The mean and standard deviation of the CFU of each suture for each microorganism will be calculated by the kruskal-wallis test, and also between the two sutures will be compared with the Mn-Yo-Whitney test.
Participants/Inclusion and exclusion criteria
Enterococcus and E.coli microorganisms on sutures of 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
Use of various suture materials in the surgical sites in all patients
Main outcome variables
accumulation of bacteria on surgical sutures
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180617040117N1
Registration date:2018-10-31, 1397/08/09
Registration timing:prospective
Last update:2018-10-31, 1397/08/09
Update count:0
Registration date
2018-10-31, 1397/08/09
Registrant information
Name
Ardavan Etemadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2256 4571
Email address
a-etemadi@farabi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-03, 1397/08/12
Expected recruitment end date
2018-12-03, 1397/09/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of four suture materials on the accumulation of Enterococcus and E.coli microorganisms in patients undergoing dental implant surgery
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:
The patient should not have any periodontal diseases
The patient should not have any systemic diseases
The patient should not take any other medicines
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
20
More than 1 sample in each individual
Number of samples in each individual:
4
Every patient has four suture materials in his mouth as sample
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
After implantation, the surgeon uses four types of suture materials with random sequences and one week after surgury, sutures will be delivered to the microbiologist as numerical codes so microbiologist doesn’t know the type of suturs.
Placebo
Not used
Assignment
Single
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
2018-10-13, 1397/07/21
Ethics committee reference number
IR.IAU.DENTAL.REC.1397/31
Health conditions studied
1
Description of health condition studied
surgical site infection
ICD-10 code
ICD-10 code description
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: The same intervention is applied to all patients, and the intervention involves the use of four different types of suture material
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
private office of Dr.ardavan Etemadi
Full name of responsible person
Ardavan Etemadi
Street address
No.12 , Narenjestan7 Ave, Farmaniye Town
City
Tehran
Province
Tehran
Postal code
1957944931
Phone
+98 21 2611 2096
Email
a-etemadi@farabi.tums.as.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
1
Public or private sector
Private
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
Ardavan Etemadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 4, 10th Neyestan, Pasdaran
City
Tehran
Province
Tehran
Postal code
1957944931
Phone
+98 21 2256 4571
Fax
+98 21 2611 2094
Email
a-etemadi@farabi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ardavan Etemadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.12 , Narenjestan7 Ave , Farmaniyeh Town
City
Tehran
Province
Tehran
Postal code
1957944931
Phone
+98 21 2611 2096
Email
a-etemadi@farabi.tums.as.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Ardavan Etemadi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.12 , Narenjestan7 Ave , Farmaniyeh Town
City
Tehran
Province
Tehran
Postal code
1957944931
Phone
+98 21 2611 2096
Email
a-etemadi@farabi.tums.as.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