Introduction: Two common mouth rinses in markets are Oral-B solution and Irsha solution. The goal of this study is the comparison of the efficacy of Oral-B and Irsha fluoride mouth rinses on Streptococcus mutans. This is a randomized, single blind trial. 60 healthy girl students studying in high school with no history of taking antibiotics during recent 6 months, good oral health (at least two times of tooth brushing a day),and without rampant caries will recruit. Exclusion criteria are discontinuation of cooperation during study, and also involvement by any kind of disease and subsequent antibiotic administration during study. These girls are completely aware about the contribution in the research program and written informed consent is taken from them. These 60 students randomly allocated into two equal groups of 30 individuals.
Intervention is consumption of Oral-B and Irsha mouth rinse ,so Oral-B mouth rinse is given to one group and Irsha mouth rinse is given to another group and they are asked to use mouth rinse as long for 4 weeks, twice a day(before tooth brushing ,after breakfast and dinner .Outcome measure is counting colonies of Streptococcus mutans, so saliva of each person is collected before and after using mouth rinse and is sent to laboratory for microbial cultures. Finally data is analyzed by T-test in the 0.95 confidence.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201103085998N2
Registration date:2011-05-11, 1390/02/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-05-11, 1390/02/21
Registrant information
Name
Romina Mazaheri
Name of organization / entity
Islamic Azad University Khorasgan Branch
Country
Iran (Islamic Republic of)
Phone
00983115354053 ; 00989133135708
Email address
r.mazaheri@khuisf.ac.ir
Recruitment status
Recruitment complete
Funding source
Costs have been payed by student of dentistry(Azade Tajalli)
Expected recruitment start date
2004-10-22, 1383/08/01
Expected recruitment end date
2006-10-23, 1385/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of two fluoride mouthrinses on Streptococcus mutans of saliva
Public title
Efficacy of mouthrinses in prevention of caries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :agreement and perfect cooperation of contributors, absence of any systemic disorders ,no antibiotic coverage during recent 6 months ago, good oral health(at least two times of toothbrushing a day), uninvolvement to rampant caries, absence of any orthodontic appliance.
Exclusion criteria: discontinuation of cooperation during study ,involvement by any kind of disease during study,consumption of antibiotics during study
Age
From 15 years old to 15 years old
Gender
Female
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
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Dentistry, Islamic Azad University Khorasgan Branch
Street address
Khorasgan Branch, Islamic Azad University - Arghavanieh st -Jey st -Isfahan
City
Isfahan
Postal code
Approval date
2004-04-23, 1383/02/04
Ethics committee reference number
23810201832001
Health conditions studied
1
Description of health condition studied
microbiology of saliva
ICD-10 code
K00-K93
ICD-10 code description
Diseases of oral cavity, salivary glands and jaws
Primary outcomes
1
Description
number of colonies of Streptococcus mutans
Timepoint
befor intervention,4 weeks after intervention
Method of measurement
visual counting the number of colonies of Streptococcus mutans
Secondary outcomes
empty
Intervention groups
1
Description
consumption of Irsha mouthrinse ( 15 cc of mouthrinse for 30 seconds,2 times a day,for 4 weeks)
Category
Prevention
2
Description
consumption of Oral-B mouthrinse ( 15 cc of mouthrinse for 30 seconds,2 times a day,for 4 weeks)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Zandizadeh ,boarding high school
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tajalli
Full name of responsible person
Azade Tajalli
Street address
Khorasgan Branch, Islamic Azad University - Arghavanieh st -Jey st -Isfahan
City
isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tajalli
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
Islamic Azad University Khorasgan Branch
Full name of responsible person
Romina Mazaheri
Position
Assistant Professor, Department of Pediatrics, School of Dentistry, Islamic Azad University Khoras
Other areas of specialty/work
Street address
Khorasgan Branch, Islamic Azad University - Arghavanieh st -Jey st -Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4053
Fax
Email
r.mazaheri@khuisf.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch
Full name of responsible person
Romina Mazaheri
Position
Assistant Professor, Department of Pediatrics, School of Dentistry, Islamic Azad University Khoras
Other areas of specialty/work
Street address
Khorasgan Branch, Islamic Azad University - Arghavanieh st -Jey st -Isfahan
City
Isfahan
Postal code
Phone
+98 31 1535 4053
Fax
Email
r.mazaheri@khuisf.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Khorasgan Branch
Full name of responsible person
Romina Mazaheri
Position
Assistant Professor, Department of Pediatrics, School of Dentistry, Islamic Azad University Khorasga
Other areas of specialty/work
Street address
Khorasgan Branch, Islamic Azad University - Arghavanieh st -Jey st -Isfahan Isfahan Isfahan Iran, Islamic Republic Of 00983115354053 00989133135708 r.mazaheri@khuisf.ac.ir
City
Isfahan
Postal code
Phone
+98 31 1535 4053
Fax
Email
r.mazaheri@khuisf.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)