This is an interventional study in a randomized clinical trial. Fifty medically healthy patients who present to the Periodontology Department of Dentistry College inter to the study. After assessment of plaque index, according to this value, each patient belongs to one of the groups; study or control in a randomized manner. Ten minutes before scaling patients rinse with 50 ml chlorhexidine or normal saline in each group. Supra gingival Scaling will be done for anterior teeth of mandible, and thereafter sampling will be done of buccal and lingual gingival grooves by means of paperpoint. These samples in a liquid transport medium, will be sent to microbiology laboratory for colony count enumeration of alpha-hemolytic streptococcus and staphylococcus aureus. This microbial flora can inter to blood circulation during scaling procedure and can be related to bacterial endocarditis in susceptible patients. So the effectiveness of an antimicrobial mouthwash can be useful in endocarditis prevention due to dental scaling in susceptible patients.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013110115233N1
Registration date:2014-01-02, 1392/10/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-02, 1392/10/12
Registrant information
Name
Samira Hajimaghsoodi
Name of organization / entity
Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1726 1255
Email address
shmaghsoodi@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Univesity of Medical Sciences.
Expected recruitment start date
2014-01-05, 1392/10/15
Expected recruitment end date
2014-02-20, 1392/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effectiveness of chlorhexidine rinse before scaling on the amount of alpha-hemolytic streptococcus and staphylococcus aureus.
Public title
mouth wash effect on oral microbial load in the time of scaling
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: all patients present to the Periodontology Department of Dentistry College who need scaling of anterior mandible teeth; lacking diabetes mellitus, HIV and current pregnancy; lacking antibiotic consumption during the past 3 month; lacking oral corticosteroid consumption during the past month; lacking necessity of antibiotic prophylaxis; lacking active dental caries or infection in the area of sampling.
Exclusion criteria: loss of tendency to participate in this study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Science
Street address
Bahonar square
City
Yazd
Postal code
Approval date
2013-03-17, 1391/12/27
Ethics committee reference number
17/1/188722/پ
Health conditions studied
1
Description of health condition studied
gingival Staphylococcus aureus colony forming unit
ICD-10 code
B95.6
ICD-10 code description
Staphylococcus aureus as the cause of diseases classified to other chapters
2
Description of health condition studied
gingival Streptococcus group A colony forming unit
ICD-10 code
B95.0
ICD-10 code description
Streptococcus, group A, as the cause of diseases classified to other chapters
Primary outcomes
1
Description
number of staphylococus ureous colonies
Timepoint
10 minutes after intervention
Method of measurement
counting staphylococus ureous colonies per each mililiter of sample
2
Description
number of stereptococus viridance colonies
Timepoint
10 minutes after intervention
Method of measurement
counting stereptococus viridance colonies per each mililiter of sampel
Secondary outcomes
1
Description
plaque index
Timepoint
before intervention
Method of measurement
number of plaque positive dental surfaces
Intervention groups
1
Description
in the case group rinsing with 50 ml chlorhrxidine 0.2% mouthwash for one minute.
Category
Prevention
2
Description
in control group rinsing with 50 ml normal saline for one minute.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Periodontology Department of Dentistry College
Full name of responsible person
Dehghan Soghra
Street address
Dentistry college, Emem street
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoughi University of Medical Science
Full name of responsible person
Mrs Maserrat
Street address
Dentistry College, Emam street
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi University of Medical Science
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
Dentistry College
Full name of responsible person
Samira Hajimaghsoodi
Position
Resident of Oral Medicine
Other areas of specialty/work
Street address
Dentistry College, Emam street
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
Email
shmaghsoodi@ssu.ac.ir shmaghsoodi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Dentistry College
Full name of responsible person
Samira Hajimaghsoodi
Position
Resident of Oral Medicine
Other areas of specialty/work
Street address
Dentistry College, Emam street
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
Email
shmaghsoodi@ssu.ac.irshmaghsoodi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Dentistry College
Full name of responsible person
Samira Hajimaghsoodi
Position
Resident of Oral Medicine
Other areas of specialty/work
Street address
Dentistry College, Emam street
City
Yazd
Postal code
Phone
+98 35 1625 5881
Fax
Email
shmaghsoodi@ssu.ac.ir shmaghsoodi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)