Xylitol clinical studies for prevention: In-school xylitol gummy bear snack study

ISRCTN	ISRCTN63160504
DOI	https://doi.org/10.1186/ISRCTN63160504
Secondary identifying numbers	U54 DE14254

Submission date: 07/02/2008
Registration date: 26/02/2008
Last edited: 30/07/2008

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
Room B-509
Box 357475
Seattle
98195
United States of America

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

Study information

Study design	Randmised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Scientific title	School-based xylitol gummy bears snacks: a randomized controlled trial
Study objectives	Consumption of xylitol gummy snacks reduces S. mutans and Lactobacillus spp. levels
Ethics approval(s)	University of Washington Internal Review Board. Date of approval: 27 March 2007 (ref: HS # 07-4857-B 01)
Health condition(s) or problem(s) studied	Dental caries
Intervention	Randomisation was carried out at the level of individuals. Gummy bear snacks were packaged by the unit-dose and labeled specific to the students ID number which corresponded with the individual randomization. Three-group design: Group 1: Xylitol gummy bears, 11.7 g/day xylitol Group 2: Xylitol gummy bears, 15.6 g/day xylitol Group 3: Maltitol gummy bear (control) All groups consumed gummy bears 3 times/day for 6 weeks in the classroom during school hours only.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	xylitol
Primary outcome measure	S. mutans and Lactobacillus spp. levels in plaque samples at enrollment (baseline) and 6 weeks (end of study).
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/04/2007
Completion date	01/06/2007

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	153
Key inclusion criteria	Children attending First through Fifth grade at two elementary schools in rural Washington State, USA
Key exclusion criteria	Children with gastrointestinal problems
Date of first enrolment	01/04/2007
Date of final enrolment	01/06/2007

Locations

Countries of recruitment

United States of America

Study participating centre

Dental Public Health Sciences

Seattle
98195
United States of America

Sponsor information

University of Washington (USA)
University/education

c/o Ms Carol Zuiches
Assistant to the Vice Provost for Research
Office of Sponsored Programs
1100 45th Street
NE, Ste. 300
Seattle
98195
United States of America

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

Funders

Funder type

Research organisation

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	25/07/2008		Yes	No