After approval of the project and coordinate with the laboratory Shyahid Beheshti Dental School, 60 students are selected on the basis of having the condition. Among the conditions for entry into the study sample; tooth decay or caries-free and have no periodontal disease and other gum of any kind should not be used during the study. After signing the informed consent, which was approved by the ethics committee, students will be divided into two groups of 30; then saliva sent to the laboratory and measured the salivary mutans streptococci, then randomly assigned to groups of type sag and more homogeneous stratified blocks simultaneously group A and group B xylitol chewing gum and Recaldent chewing gum, 3 times a day (every time 20 minutes) for 3 weeks. After the specified time period (3 weeks), saliva samples were collected again and are sent to the shahid Beheshti laboratory immediately and change in salivary streptococcus mutans of each group are measured, recorded and compared.
General information
Acronym
E Ch. g CPP-ACP &Z on SM
IRCT registration information
IRCT registration number:IRCT2014063018296N1
Registration date:2014-08-02, 1393/05/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-08-02, 1393/05/11
Registrant information
Name
Yosra Khateri Zadeh
Name of organization / entity
International Branch of Shahid Beheshti University Dental School
Country
Iran (Islamic Republic of)
Phone
Email address
yosra_khaterizadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
The International branch of shahid beheshti university of medical sciences dental school
Expected recruitment start date
2014-08-02, 1393/05/11
Expected recruitment end date
2014-08-07, 1393/05/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of two typs of chewing gum containing casein phosphopeptide-amorphous calcium phosphate and xylitol on amounts of streptococcus mutans.
Public title
The effect of two types of chewing gum containing CPP - ACP and xylitol on caries-causing bacteria in the mouth.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. No tooth decay or caries. 2. Lack of systemic antibiotics during the last 3 months. 3. Topical fluoride therapy during the 4-week period before baseline were not include. 4. No signs of any gingivitis or periodontal diseases. 5. Do not have habitual use of dairy xylitol or recaldent chewing gum. 6. Do not have smoking habit. 7.Have no history of systemic disease. Exclusion criterion: patients will to be excluded from the study.
Age
From 20 years old to 25 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
International Branch of Shahid Beheshti University of Medical Sciences, Dental School
Street address
19 shahid abbaspour St,vali-asr Ave, Tehran-Iran
City
Tehran
Postal code
141553693
Approval date
2014-07-22, 1393/04/31
Ethics committee reference number
1000/289
Health conditions studied
1
Description of health condition studied
Initial caries & salivary mutans streptoccus
ICD-10 code
K02.0
ICD-10 code description
Caries limited to enamel
Primary outcomes
1
Description
Streptococcus mutans
Timepoint
Baseline salivary streptococcus mutans and after chewing gum salivary SM is measured.
Method of measurement
Saliva is collected by sterile micro tubes.
Secondary outcomes
1
Description
Side effects of CPP-ACP has been not reported but people who have allergies to milk not to use the gum.
Timepoint
During of study
Method of measurement
If see any signs.
Intervention groups
1
Description
Group II: chewing gum containing CPP-ACP. After selecting individuals for entry into the study and informed consent and informed them orally A 30-member is asked daily after breakfast and after lunch and dinner take away their toothbrushes every meal a grain of chewing gum for 20 minutes and then take away the gum. These Mtah is 3 weeks. (Gum weight = 47.6 grams)
Category
Prevention
2
Description
Group I: chewing gum containing xylitol. After selecting individuals for entry into the study and informed consent and informed them orally A 30-member is asked daily after breakfast and after lunch and dinner take away their toothbrushes every meal a grain of chewing gum for 20 minutes and then take away the gum. These Mtah is 3 weeks. (Gum weight = 31 grams)
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
International Branch of Shahid Beheshti University of Medical Sciences, Dental School