This study will be conduct to find the appropriate procedure to reduce the microbial pollution in surgical site after periodontal surgery. Thirty two patients who are candidate for modified widman flap surgery in jaws and could have good plaque control will be recruit. The surgery will be perform on one side of jaw which is randomly select and surgical site suture with silk (supusil , 26, 3-0) in form of direct loop and cover with periodontal pack ; after one week the patient will be recall and the pack and the sutures are removed. Three of sutures will be transfere by a sterile vial containing phosphate buffered saline. The vials will be shak for 45 minutes so that all of attached bacteria detache. The prepared solution carry to chocolate agar, blood agar, EMB culture medias and incubate in 37C for 24 hours. Then 100 landa of each of culture media is taken and added to Mc farland tubes and the colony count of bacteria will be detect with Mc farland dilution series. After 3 week interval the other side will be treat with M.W.F surgery and the surgical site is suturing with the same sutures and the patient is discharged without periodontal pack. After a week the sutures are removing and the same procedure is done and finally results will be compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201011034877N2
Registration date:2011-05-03, 1390/02/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-03, 1390/02/13
Registrant information
Name
Jaber Yaghini
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 1434 2136
Email address
j_yaghini@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Faculty of Dentistry, Isfahan University of Medical Sciences
Expected recruitment start date
2010-12-05, 1389/09/14
Expected recruitment end date
2011-03-17, 1389/12/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of microbial colony count of sutures with and without use of periodontal pak after modified widman flap surgery
Public title
Evaluation of microbial pollution related to periodontal paks after periodontal surgery. Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria
The patients who are candidate for M.W.F in 2 quadrants of a jaw or opposite jaws.
Having the equal number of teeth in both sides of jaw or in opposite jaws.
Exclusion criteria:
Smoking, having clinical or radiological problem other than periodontal disease
Use of antibiotics.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Vice Chancellor for research,Isfahan Faculty of Dentistry
Street address
Vice Chancellor for research -Isfahan Faculty of Dentistry
City
Isfahan
Postal code
Approval date
2010-05-21, 1389/02/31
Ethics committee reference number
389157
Health conditions studied
1
Description of health condition studied
Periodontal Diseases
ICD-10 code
k05.6
ICD-10 code description
Periodontal Diseases Unspecified
Primary outcomes
1
Description
Microbial colony count
Timepoint
One week after intervention
Method of measurement
Counts of microbial colony per ml
Secondary outcomes
empty
Intervention groups
1
Description
Administration of periodontal pack in intervention site
Category
Prevention
2
Description
Not using the periodontal pack in control site
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaedi Dentistry Clinic
Full name of responsible person
Dr. Jaber Yaghini
Street address
Baborahmeh st- Emam Hossein sq- Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Faculty of Dentistry, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Omid Savabi
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
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, Faculty of Dentistry, Isfahan 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
Isfahan Faculty of Dentistry
Full name of responsible person
Dr.Jaber Yaghini
Position
Proficiency in Periodontics
Other areas of specialty/work
Street address
Department of Periodontology, Faculty of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2842
Fax
Email
J_Yaghini@dnt.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Faculty of Dentistry
Full name of responsible person
Dr.Jaber Yaghini
Position
Proficiency in Periodontics
Other areas of specialty/work
Street address
Periodontology Department, Faculty of Dentistry, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2842
Fax
Email
J_Yaghini@dnt.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)