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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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TCTR |
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Last refreshed on:
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29 April 2024 |
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Main ID: |
TCTR20150915001 |
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Date of registration:
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15/09/2015 |
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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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Do the Dental Health Benefits of Yakult® Continue After Intake Stops?
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Scientific title:
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Sustainability and Mechanism of Yakult®’s Cariostatic Effects |
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Date of first enrolment:
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28/05/2012 |
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Target sample size:
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Recruitment status: |
Completed |
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URL:
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https://www.thaiclinicaltrials.org/show/TCTR20150915001 |
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Study type:
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Interventional |
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Study design:
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N/A
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Phase:
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N/A
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Countries of recruitment
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Singapore
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Contacts
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Name:
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Chin-Ying Stephen
Hsu |
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Address:
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Faculty of Dentistry, National University of Singapore, 11 Lower Kent Ridge Road
119083
Singapore
Singapore |
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Telephone:
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(65)67726832 |
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Email:
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denhsus@nus.edu.sg |
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Affiliation:
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Faculty of Dentistry, National University of Singapore |
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Name:
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Chin-Ying Stephen
Hsu |
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Address:
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Faculty of Dentistry, National University of Singapore, 11 Lower Kent Ridge Road
119083
Singapore
Singapore |
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Telephone:
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(65)67726832 |
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Email:
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denhsus@nus.edu.sg |
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Affiliation:
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Faculty of Dentistry, National University of Singapore |
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Key inclusion & exclusion criteria
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Inclusion criteria: Healthy (no systemic disease)
Exclusion criteria: Smoking
Alcoholism
Pregnancy
Prior dental restorations on the maxillary canines and premolars
Habitual consumers of Yakult® probiotic beverage
Age minimum:
21 Years
Age maximum:
40 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dental caries
Probiotics
Lactobacillus casei Shirota
Yakult
Dental caries
Dental caries susceptibility
Dental caries activity tests
Acidogenicity
Stephan curve
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Probiotics
Lactobacillus casei Shirota
Yakult
Dental caries
Dental caries susceptibility
Dental caries activity tests
Acidogenicity
Stephan curve
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Intervention(s)
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Standard Yakult (fermented milk containing live probiotic Lactobacillus casei Shirota bacteria)
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All participants received 7 x 100 ml bottles of standard Yakult at the start of the study. Participants were instructed to consume one bottle daily for 7 consecutive days, after dinner and over a period of 30 seconds.
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Experimental Dietary Supplement
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Primary Outcome(s)
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Area under the Stephan curve Before intervention (day 1); 7 and 21 days after experiment start Area under Stephan curve (pH/time) bounded by curve and pH 5.5, after 10% sucrose challenge.,Lowest pH Before intervention (day 1); 7 and 21 days after experiment start Minimum pH observed from the Stephan curve,pH recovery time Before intervention (day 1); 7 and 21 days after experiment start Duration between the two times the Stephan curve touched the horizontal line denoting pH 5.5
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Secondary Outcome(s)
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Levels of plaque Streptococcus mutans and Lactobacillus casei Shirota bacteria Before intervention (day 1); 7 and 21 days after experiment start Real-time PCR specific for S. mutans and L. casei strain Shirota bacteria,Cariogram risk assessment Experiment start (day 1) Survey; mutans streptococci and Lactobacillus counts; salivary buffer capacity
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Source(s) of Monetary Support
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Faculty of Dentistry Undergraduate Research Opportunities Programme
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Ethics review
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Status: Submitted, approved
Approval date:
Contact:
irb@nus.edu.sg
National University of Singapore Institutional Review Board
(65)65165453 Ext.
irb@nus.edu.sg
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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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04/06/2012 |
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URL:
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