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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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ClinicalTrials.gov |
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Last refreshed on:
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14 March 2016 |
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Main ID: |
NCT02692625 |
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Date of registration:
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23/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Consumption Effect of Probiotic Products on Salivary Cariogenic Bacterial Counts in Preschool Children.
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Scientific title:
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Consumption Effect of Probiotic Products on Salivary Cariogenic Bacterial Counts in Preschool Children. |
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Date of first enrolment:
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January 2015 |
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Target sample size:
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160 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02692625 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Saudi Arabia
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Contacts
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Name:
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Najlaa M Alamoudi, DSc |
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Address:
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Telephone:
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6400000 |
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Email:
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nalamoudi@kau.edu.sa |
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Affiliation:
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Name:
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Najlaa M Alamoudi, BDS, MS, DS |
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Address:
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Telephone:
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+966 2 6401000 |
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Email:
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nalamoudi2011@kau.edu.sa |
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Affiliation:
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Name:
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Najlaa M Alamoudi, BDS, MS, DS |
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Address:
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Telephone:
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Email:
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Affiliation:
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King Abdulaziz University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy children having no history of any systemic conation, having full set of
primary dentition, having high counts of salivary mutants streptococci ( = 105 CFU ),
dft score = 3, with no history of recent antibiotics administration (At least one
month prior to the intervention) .
Exclusion Criteria:
- Disapproved consent, medically compromised children, children using topical fluoride
within the 4 weeks prior to baseline except the fluoride in the toothpaste, and
children using xylitol chewing gums.
Age minimum:
3 Years
Age maximum:
6 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dental Caries
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Intervention(s)
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Dietary Supplement: (L. reuteri Prodentis®).
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Dietary Supplement: Placebo lozenges
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Primary Outcome(s)
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The salivary mutans streptococci and lactobacilli counts
[Time Frame: 2 months]
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Secondary Outcome(s)
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Dental plaque accumulation.
[Time Frame: 2 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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