Contact information
Type
Scientific
Primary contact
Prof Peter Milgrom
ORCID ID
Contact details
Dental Public Health Sciences
1959 NE Pacific Street
Rm B-509
Box 357475
Seattle
Washington
98195
United States of America
+1 206 543 4043
dfrc@u.washington.edu
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
U54 DE14254
Study information
Scientific title
Acronym
Gum 2
Study hypothesis
Increasing reduction in mutans streptococci level in plaque and saliva to increasing frequency of xylitol use at the same total daily dose.
Ethics approval
University of Washington Internal Review Board - Application#: 04-2024-B 01. Approved 17/06/2004.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Dental caries
Intervention
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.
Intervention type
Drug
Phase
Not Specified
Drug names
Xylitol
Primary outcome measures
Reduction in mutans streptococci level in plaque and saliva
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/04/2004
Overall trial end date
01/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
Adult, male & female, with screening plaque mutans streptococci level greater than 10,000 CFU/ml
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
132
Participant exclusion criteria
1. Gastro-intestinal diseases/problems
2. Phenylalanine intolerant
Recruitment start date
01/04/2004
Recruitment end date
01/03/2005
Locations
Countries of recruitment
United States of America
Trial participating centre
Dental Public Health Sciences
Seattle, Washington
98195
United States of America
Sponsor information
Organisation
University of Washington (USA)
Sponsor details
Carol Zuiches
Asst Vice Provost for Research
Office of Sponsored Programs
1100 45th St.
NE
Ste. 300
Seattle
Washington
98105
United States of America
+1 206 543 4043
gcsvcs@u.washington.edu
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
National Institute of Dental and Cranio-facial Research (NIDCR) (USA) - ref: U54 DE14254
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16556326
Publication citations
-
Results
Ly KA, Milgrom P, Roberts MC, Yamaguchi DK, Rothen M, Mueller G, Linear response of mutans streptococci to increasing frequency of xylitol chewing gum use: a randomized controlled trial [ISRCTN43479664]., BMC Oral Health, 2006, 6, 6, doi: 10.1186/1472-6831-6-6.