Xylitol Clinical Studies for Prevention - Xylitol Frequency Study (Gum 2)

ISRCTN	ISRCTN43479664
DOI	https://doi.org/10.1186/ISRCTN43479664
Protocol serial number	U54 DE14254
Sponsor	University of Washington (USA)
Funder	National Institute of Dental and Cranio-facial Research (NIDCR) (USA) - ref: U54 DE14254

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Peter Milgrom
Scientific

Dental Public Health Sciences
1959 NE Pacific Street
Rm B-509
Box 357475
Seattle, Washington
98195
United States of America

Phone	+1 206 543 4043
Email	dfrc@u.washington.edu

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	Gum 2
Study objectives	Increasing reduction in mutans streptococci level in plaque and saliva to increasing frequency of xylitol use at the same total daily dose.
Ethics approval(s)	University of Washington Internal Review Board - Application#: 04-2024-B 01. Approved 17/06/2004.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Xylitol
Primary outcome measure(s)	Reduction in mutans streptococci level in plaque and saliva
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/03/2005

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	132
Key inclusion criteria	Adult, male & female, with screening plaque mutans streptococci level greater than 10,000 CFU/ml
Key exclusion criteria	1. Gastro-intestinal diseases/problems 2. Phenylalanine intolerant
Date of first enrolment	01/04/2004
Date of final enrolment	01/03/2005

Dental Public Health Sciences

Seattle, Washington
98195
United States of America

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	24/03/2006		Yes	No