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Xylitol Clinical Studies for Prevention - Xylitol Frequency Study (Gum 2)
ISRCTN ISRCTN43479664
DOI 10.1186/ISRCTN43479664
ClinicalTrials.gov identifier
EudraCT number
Public title Xylitol Clinical Studies for Prevention - Xylitol Frequency Study (Gum 2)
Scientific title
Acronym Gum 2
Serial number at source U54 DE14254
Study hypothesis Increasing reduction in mutans streptococci level in plaque and saliva to increasing frequency of xylitol use at the same total daily dose.
Lay summary
Ethics approval University of Washington Internal Review Board - Application#: 04-2024-B 01. Approved 17/06/2004.
Study design Randomised controlled trial
Countries of recruitment United States of America
Disease/condition/study domain Dental caries
Participants - inclusion criteria Adult, male & female, with screening plaque mutans streptococci level greater than 10,000 CFU/ml
Participants - exclusion criteria 1. Gastro-intestinal diseases/problems
2. Phenylalanine intolerant
Anticipated start date 01/04/2004
Anticipated end date 01/03/2005
Status of trial Completed
Patient information material
Target number of participants 132
Interventions 4 group design. Control (sorbitol gum) group and 3 xylitol gum groups who consumed 10.32 g xylitol per day. All 4 groups chewed 12 pellets of gum per day. Xylitol groups evenly divided the 12 gums into 2, 3, or 4 chewing frequency. Controls chewed sorbitol gums 4 times per day.
Primary outcome measure(s) Reduction in mutans streptococci level in plaque and saliva
Secondary outcome measure(s) Not provided at time of registration
Sources of funding National Institute of Dental and Cranio-facial Research (NIDCR) (USA) - ref: U54 DE14254
Trial website
Publications 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16556326
Contact name Prof  Peter  Milgrom
  Address Dental Public Health Sciences
1959 NE Pacific Street
Rm B-509
Box 357475
  City/town Seattle, Washington
  Zip/Postcode 98195
  Country United States of America
  Tel +1 206 543 4043
  Fax +1 206 685 4258
  Email dfrc@u.washington.edu
Sponsor University of Washington (USA)
  Address Carol Zuiches
Asst Vice Provost for Research
Office of Sponsored Programs
1100 45th St.
NE, Ste. 300
  City/town Seattle, Washington
  Zip/Postcode 98105
  Country United States of America
  Tel +1 206 543 4043
  Fax +1 206 685 1732
  Email gcsvcs@u.washington.edu
  Sponsor website: http://www.washington.edu/research/osp/index.php
Date applied 16/11/2005
Last edited 13/10/2009
Date ISRCTN assigned 22/11/2005
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