Xylitol Clinical Studies for Prevention - Xylitol Snack Foods among Adults Study (Gum 3)

ISRCTN	ISRCTN25845456
DOI	https://doi.org/10.1186/ISRCTN25845456
Secondary identifying numbers	U54 DE14254

Submission date: 16/11/2005
Registration date: 02/12/2005
Last edited: 20/08/2009

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

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	+1 206 685 4183
Email	dfrc@u.washington.edu

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title
Study acronym	Gum 3
Study objectives	Reduction in mutans strepotococci by xylitol snack foods is equivalent to xylitol chewing gum among adults
Ethics approval(s)	University of Washington Internal Review Board - Application#: 05-5945-B 01. Approved 29/03/2005.
Health condition(s) or problem(s) studied	Dental Caries
Intervention	Please note that this trial was stopped during the recruitment phase due to reconsideration of power calculations and insufficient resources. An alternative approach to gaining the information was used and the results have been published in http://www.ncbi.nlm.nih.gov/pubmed/18267030. Interventions: Two group design with positive control. Equivalence study, xylitol Gummy Bears (10.4 g/day) compared to xylitol chewing gum (10.3 g/day).
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Xylitol
Primary outcome measure	Reduction in mutans streptococci level in plaque
Secondary outcome measures	Not provided at time of registration
Overall study start date	15/05/2005
Completion date	01/04/2006
Reason abandoned (if study stopped)	Lack of funding/sponsorship

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	140
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	15/05/2005
Date of final enrolment	01/04/2006

Locations

Countries of recruitment

United States of America

Study participating centre

Dental Public Health Sciences

Seattle, Washington
98195
United States of America

Sponsor information

University of Washington (USA)
University/education

Carol Zuiches
Asst Vice Provost for Research
Office of Sponsored Programs
1100 45th St.
NE, Ste. 300
Seattle, Washington
98195
United States of America

Phone	+1 206 543 4043
Email	gcsvcs@u.washington.edu
Website	http://www.washington.edu/research/osp/index.php
"ROR"	https://ror.org/00cvxb145

Funders

Funder type

Government

National Institute of Dental and Cranio-facial Research (NIDCR) (USA), ref: U54 DE14254

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan