Despite the health advantages of orthodontics on the oral and dental health, the presence of orthodontic brackets creates obstacle for patients such as increased accumulation of bacterial plaques. During fixed-treatment the absolute number of salivary Streptococcus mutans, as well as the percentage of Streptococcus mutans were increased which leads to increased occurrence of demineralized lesions and dental caries. The purpose of present study was to evaluate the efficacy of fluoride-releasing elastomeric chains in the control of Streptococcus mutans level in the saliva and surrounding the orthodontic appliances plaque.
Sixty patients, who would undergoing fixed-orthodontic appliance treatment would selected and randomly divided into 2 groups of 30.patients must would in overall health situation and do not have any systemic disease In group 1 fluoride-release elastomeric chains would used and conventional elastomeric chains used in group 2. Saliva would collected On days initial, 7, 14, 28, from both groups, and bacterial plaques sample would collected on days initial, 28. At day 28, the fluoride-release and conventional elastomeric chains would removed. All samples would transferred for microbial culture in order to counting the Streptococcus mutans colonies.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT201110317959N1
Registration date:2012-02-12, 1390/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-12, 1390/11/23
Registrant information
Name
Samaneh Sadeghy
Name of organization / entity
Post graduate student
Country
Iran (Islamic Republic of)
Phone
+98 71 1628 0801
Email address
sadeghysa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Office of Vice Chancellor for Research of Shiraz University of Medical Sciences
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-01-15, 1390/10/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the effect of fluoride–releasing elastomeric chains on the number of Streptococcus mutans in orthodontic patients.
Public title
Clinical evaluation of the effect of fluoride–releasing elastomeric chains on the number of Streptococcus mutans in orthodontic patients.
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria are:18-28 years old؛ teeth with normal size؛ are in overall health situation؛ do not used antibiotics within the previous 2 weeks. Exclusion criteria: lake of above criteria
Age
From 18 years old to 28 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical Committee on Shiraz Medical Science University
Street address
Ethical Committee on Shiraz Medical Science University; Medicine faculty; Zand Blv;
City
Shiraz
Postal code
-
Approval date
2011-12-01, 1390/09/10
Ethics committee reference number
CT-90-3596
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
R19.8
ICD-10 code description
Other specified symptoms and signs involving the digestive system and abdomen
Primary outcomes
1
Description
Streptpcpccus mutans bacteria
Timepoint
on days 0; 7; 14; 28
Method of measurement
counting number of Streptococcus mutans colonies
Secondary outcomes
empty
Intervention groups
1
Description
study group: fluoride releasing elastomeric chains would used
Category
Prevention
2
Description
control group: conventional elastomeric chains used
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics, Dentistry Faculty
Full name of responsible person
Dr Samaneh Sadeghy
Street address
Dentistry Faculty; Qom abad Ave
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Office of Vice Chancellor for Research of Shiraz University of Medical Sciences
Full name of responsible person
Dr Gholam Reza Hattam
Street address
Shiraz Medical Science University; zand.blv
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Office of Vice Chancellor for Research of Shiraz 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
Orthodontic Research Center
Full name of responsible person
Dr Samaneh Sadeghi
Position
Post graduate
Other areas of specialty/work
Street address
Faculty of Dentistry of Shiraz Medical Science University; Qom abad
City
Shiraz
Postal code
71956-15878
Phone
+98 71 1628 9913
Fax
+98 71 1628 0801
Email
samaneh_sa82@yahoo.com samaneh.sa82@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Orthodontic research center; dental faculty of shiraz medical science
Full name of responsible person
Dr Zohre Hedayati
Position
Master of Science in Orthodontics
Other areas of specialty/work
Street address
Department of Orthodontics,Dentistry faculty; Qom abad
City
Shiraz
Postal code
71345-1836
Phone
+98 71 1628 0801
Fax
+98 71 1628 0801
Email
hedayatz@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Orthodontic Research Center of Dental Faculty
Full name of responsible person
Dr Samaneh Sadeghy
Position
Post graduat student
Other areas of specialty/work
Street address
Department of Orthodontics, dentistry faculty
City
Shiraz
Postal code
71956-15878
Phone
+98 71 1628 0801
Fax
+98 71 1628 0801
Email
samaneh_sa82@yahoo.com samaneh.sa82@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)