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

ISRCTN	ISRCTN43479664
DOI	https://doi.org/10.1186/ISRCTN43479664
Secondary identifying numbers	U54 DE14254

Submission date: 16/11/2005
Registration date: 22/11/2005
Last edited: 13/10/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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	+1 206 543 4043
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	Not Specified
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Xylitol
Primary outcome measure	Reduction in mutans streptococci level in plaque and saliva
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/04/2004
Completion date	01/03/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

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
98105
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

Study outputs

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