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Xylitol for healthy teeth and ears project
ISRCTN ISRCTN84269958
DOI 10.1186/ISRCTN84269958
ClinicalTrials.gov identifier
EudraCT number
Public title Xylitol for healthy teeth and ears project
Scientific title Xylitol for acute otitis media and early childhood caries
Acronym N/A
Serial number at source R40 MC03622
Study hypothesis Xylitol syrup reduces the incidence of dental caries and acute otitis media
Lay summary Not provided at time of registration
Ethics approval University of Washington Institutional Review Board, initial approval granted on 19 July 2005 (ref: HSD# 04-4039-B 01). The approval has been renewed annually on 17 August 2006 (ref: HSD# 04-4039-B 02) and 12 August 2007 (ref:HSD# 04-4039-B 03).
Study design Randomised controlled trial
Countries of recruitment Marshall Islands
Disease/condition/study domain Dental caries and acute otitis media
Participants - inclusion criteria Children aged 6-15 months of age living in Laura or Delap district of Majuro Atoll, the Marshall Islands
Participants - exclusion criteria Children with known gastrointestinal problems
Anticipated start date 01/04/2006
Anticipated end date 15/01/2008
Status of trial Completed
Patient information material
Target number of participants 102
Interventions Three group design:
1. Xylitol syrup 8 g/day divided into 2 doses + 1 dose of sorbitol = 3 doses/day
2. Xylitol syrup 8 g/day divided into 3 doses + 0 dose of sorbitol = 3 doses/day
3. Xylitol syrup 2.66 g/day in a single dose (positive control) + 2 doses of sorbitol = 3 doses/day

Duration of interventions: 12 months
Primary outcome measure(s) 1. Dental caries, assessed at baseline (at randomization), mid study (5-6 months), and 12 months (end of study period)
2. Acute otitis media (incidence rate). Children were assessed as symptoms suggestive of acute otitis media arose throughout the follow-up period (12 months)
Secondary outcome measure(s) No secondary outcome measures
Sources of funding Maternal and Child Health Bureau - Health Resources and Services Administration (MCHB - HRSA) (USA)
Trial website
Publications 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19581542
Contact name Prof  Peter  Milgrom
  Address Dental Public Health Sciences
1959 NE Pacific Street
Rm B-509
Box 357475
  City/town Seattle
  Zip/Postcode 98195
  Country United States of America
Sponsor University of Washington (USA)
  Address c/o Ms Carol Zuiches
University of Washington
Office of Sponsored Programs
1100 45th St. NE
Ste. 300
  City/town Seattle
  Zip/Postcode 98195
  Country United States of America
  Tel +1 206 543 4043
  Email gcsvcs@u.washington.edu
  Sponsor website: http://www.washington.edu/research/osp/index.php
Date applied 07/02/2008
Last edited 31/08/2011
Date ISRCTN assigned 26/02/2008
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