|
ISRCTN
|
ISRCTN43479664
|
|
ClinicalTrials.gov identifier
|
|
|
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
|
