Xylitol for healthy teeth and ears project

ISRCTN	ISRCTN84269958
DOI	https://doi.org/10.1186/ISRCTN84269958
Secondary identifying numbers	R40 MC03622

Submission date: 07/02/2008
Registration date: 26/02/2008
Last edited: 31/08/2011

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
98195
United States of America

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Prevention
Scientific title	Xylitol for acute otitis media and early childhood caries
Study objectives	Xylitol syrup reduces the incidence of dental caries and acute otitis media
Ethics approval(s)	University of Washington Institutional Review Board, initial approval granted on 19 July 2005 (ref: HSD# 04-4039-B 01). The approval has been renewed annually on 17 August 2006 (ref: HSD# 04-4039-B 02) and 12 August 2007 (ref:HSD# 04-4039-B 03).
Health condition(s) or problem(s) studied	Dental caries and acute otitis media
Intervention	Three group design: 1. Xylitol syrup 8 g/day divided into 2 doses + 1 dose of sorbitol = 3 doses/day 2. Xylitol syrup 8 g/day divided into 3 doses + 0 dose of sorbitol = 3 doses/day 3. Xylitol syrup 2.66 g/day in a single dose (positive control) + 2 doses of sorbitol = 3 doses/day Duration of interventions: 12 months
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Xylitol
Primary outcome measure	1. Dental caries, assessed at baseline (at randomization), mid study (5-6 months), and 12 months (end of study period) 2. Acute otitis media (incidence rate). Children were assessed as symptoms suggestive of acute otitis media arose throughout the follow-up period (12 months)
Secondary outcome measures	No secondary outcome measures
Overall study start date	01/04/2006
Completion date	15/01/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	15 Months
Sex	Both
Target number of participants	102
Key inclusion criteria	Children aged 6-15 months of age living in Laura or Delap district of Majuro Atoll, the Marshall Islands
Key exclusion criteria	Children with known gastrointestinal problems
Date of first enrolment	01/04/2006
Date of final enrolment	15/01/2008

Locations

Countries of recruitment

Marshall Islands
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
University of Washington
Office of Sponsored Programs
1100 45th St. 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/index.php
"ROR"	https://ror.org/00cvxb145

Funders

Funder type

Government

Maternal and Child Health Bureau - Health Resources and Services Administration (MCHB - HRSA) (USA)

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	01/07/2009		Yes	No