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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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IRCT |
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Last refreshed on:
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22 February 2018 |
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Main ID: |
IRCT2014063018296N1 |
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Date of registration:
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2014-08-02 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The effect of two types of chewing gum containing CPP - ACP and xylitol on caries-causing bacteria in the mouth.
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Scientific title:
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The effect of two typs of chewing gum containing casein phosphopeptide-amorphous calcium phosphate and xylitol on amounts of streptococcus mutans. |
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Date of first enrolment:
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2014-08-02 |
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Target sample size:
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60 |
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Recruitment status: |
Complete |
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URL:
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http://en.irct.ir/trial/16637 |
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Study type:
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interventional |
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Study design:
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Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention.
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Phase:
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N/A
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Countries of recruitment
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Iran (Islamic Republic of)
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Contacts
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Name:
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Yosra Khaterizadeh
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Address:
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Dental Clinic, Shahid Beheshti Center, South Jamalzadeh st., Azadi Ave
1454663349
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 6691 7171 |
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Email:
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Yosra_khaterizadeh@yahoo.com |
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Affiliation:
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International Branch of Shahid Beheshti University of Medical Sciences, Dental School |
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Name:
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Yosra Khaterizadeh
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Address:
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Dental Clinic, Shahid Beheshti Center, South Jamalzadeh st., Azadi Ave.
1454663349
Tehran
Iran (Islamic Republic of) |
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Telephone:
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+98 21 6691 7171 |
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Email:
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Yosra_khaterizadeh@yahoo.com |
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Affiliation:
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International Branch of Shahid Beheshti University of Medical Sciences, Dental School |
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Key inclusion & exclusion criteria
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Inclusion 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.
Exclusion criteria:
Age minimum:
20 years
Age maximum:
25 years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Initial caries & salivary mutans streptoccus.
Caries limited to enamel
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Caries limited to enamel
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Intervention(s)
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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)
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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)
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Intervention 1: 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). Intervention 2: 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).
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Prevention
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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International branch of shahid beheshti university of medical sciences &health services dental s
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Ethics review
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Status: Approved
Approval date:
Contact:
International Branch of Shahid Beheshti University of Medical Sciences, Dental School
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