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ISRCTN
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ISRCTN51682476
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ClinicalTrials.gov identifier
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Public title
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Is toothpaste containing xylitol + fluoride more effective than toothpaste containing only fluoride in preventing dental caries among pre-schoolers?
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Scientific title
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A clinical trial comparing fluoride toothpaste and xylitol+fluoride toothpaste in reducing dental caries among pre-schoolers at increased risk for tooth decay: a randomised prospective trial
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Xylitol+fluoride toothpaste is more effective than fluoride toothpaste at slowing the rates of tooth decay progression in pre-schoolers
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Lay summary
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Lay summary under review
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Ethics approval
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Not provided at time of registration
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Study design
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Single-center double-blinded classroom randomized prospective clinical trial
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Countries of recruitment
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Marshall Islands
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Disease/condition/study domain
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Dental caries
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Participants - inclusion criteria
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1. Enrolled in one of four pre-schools in Majuro, Marshall Islands
2. Under age 5
3. Parent consent to participate in the trial
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Participants - exclusion criteria
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Allergy or sensitivity to fluoride toothpaste
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Anticipated start date
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01/09/2010
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Anticipated end date
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30/06/2011
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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200 participants
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Interventions
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Arm 1: supervised in-class toothbrushing once/day with xylitol+1400ppm fluoride toothpaste
Arm 2: supervised in-class toothbrushing once/day with 1400ppm fluoride toothpaste
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Primary outcome measure(s)
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Total increase in the number of primary tooth surfaces with untreated dental caries from baseline to end of school year
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Secondary outcome measure(s)
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Levels of intraoral plaque and salivary mutans streptococci (at end of school year)
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Sources of funding
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United States Health Resources and Services Administration (HRSA) (USA) - Targeted Oral Health Services Systems TOHSS Grant ref: H47MC08647
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Trial website
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Publications
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Contact name
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Dr
Ohnmar
Tut
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Address
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Republic of the Marshall Islands
Ministry of Health
Post Office Box 16
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City/town
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Majuro
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Zip/Postcode
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96960
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Country
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Marshall Islands
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Sponsor
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Republic of the Marshall Islands (Marshall Islands)
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Address
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c/o Dr Ohnmar Tut
Ministry of Health
Post Office Box 16
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City/town
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Majuro
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Zip/Postcode
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96960
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Country
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Marshall Islands
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Date applied
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18/11/2011
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Last edited
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06/01/2012
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Date ISRCTN assigned
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06/01/2012
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