Comparative of the effect of silk suture versus poliglactin 910 suture on the amount of local microbial plaque aggregation in patients who are candidate for oral surgery: a randomized clinical trial
Objectives: To compare the effect of silk suture versus poliglactin 910 suture on the amount of local microbial plaque aggregation in patients who are candidate for oral surgery.
Design: A randomized clinical trial.
Setting and conduct: The eligible patients who are candidate for oral surgery and will refer to Dentistry School during the study period will be enrolled into the trial.
Inclusion criteria: candidate for oral surgery; having bilateral impacted third molar teeth.
Exclusion criteria: history of previous surgery of third molar teeth.
Intervention group: Suturing the surgical location of the third molar using poliglactin 910 suture.
Control group: Suturing the surgical location of the third molar using silk suture.
Primary outcome: Measuring local microbial plaque aggregation on the suture on the third and seventh days after surgery using microbiological testing.
Secondary outcome: Nothing.
Randomization: Suturing randomly the surgical location of the third molar on one side by poliglactin 910 suture and the other side by silk suture.
Blinding: Not blinded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607049014N105
Registration date:2016-07-06, 1395/04/16
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-07-06, 1395/04/16
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative of the effect of silk suture versus poliglactin 910 suture on the amount of local microbial plaque aggregation in patients who are candidate for oral surgery: a randomized clinical trial
Public title
Comparative of the effect of silk suture versus poliglactin 910 suture on the amount of local microbial plaque aggregation in patients who are candidate for oral surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: candidate for oral surgery; having bilateral impacted third molar teeth.
Exclusion criteria: history of previous surgery of third molar teeth.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: Suturing randomly the surgical location of the third molar on one side by poliglactin 910 suture and the other side by silk suture.
Blinding: Not blinded.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2016-04-13, 1395/01/25
Ethics committee reference number
IR.UMSHA.REC.1395.6
Health conditions studied
1
Description of health condition studied
Impacted teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Measuring local microbial plaque aggregation on the suture
Timepoint
on the third and seventh days after surgery
Method of measurement
using microbiological testing
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Suturing the surgical location of the third molar using poliglactin 910 suture
Category
Treatment - Surgery
2
Description
Suturing the surgical location of the third molar using silk suture
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry
Full name of responsible person
Azin Khodabakhshi
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Azin Khodabakhshi
Position
Dentistry Student
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 38381086
Fax
Email
azinkhodabakhshi1992@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Dentistry
Full name of responsible person
Dr Shapour Yaripour
Position
Mandibulofacial Surgeon
Other areas of specialty/work
Street address
School of Dentistry, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 1086
Fax
Email
yaripours@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)