Condition category
Oral Health
Date applied
07/02/2008
Date assigned
26/02/2008
Last edited
31/08/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Milgrom

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R40 MC03622

Study information

Scientific title

Xylitol for acute otitis media and early childhood caries

Acronym

Study hypothesis

Xylitol syrup reduces the incidence of dental caries and acute otitis media

Ethics approval

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).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Xylitol

Primary outcome measures

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 trial start date

01/04/2006

Overall trial end date

15/01/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Children aged 6-15 months of age living in Laura or Delap district of Majuro Atoll, the Marshall Islands

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

102

Participant exclusion criteria

Children with known gastrointestinal problems

Recruitment start date

01/04/2006

Recruitment end date

15/01/2008

Locations

Countries of recruitment

Marshall Islands

Trial participating centre

Dental Public Health Sciences
Seattle
98195
United States of America

Sponsor information

Organisation

University of Washington (USA)

Sponsor details

c/o Ms Carol Zuiches
University of Washington
Office of Sponsored Programs
1100 45th St. NE
Ste. 300
Seattle
98195
United States of America
+1 206 543 4043
gcsvcs@u.washington.edu

Sponsor type

University/education

Website

http://www.washington.edu/research/osp/index.php

Funders

Funder type

Government

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19581542

Publication citations

  1. Results

    Milgrom P, Ly KA, Tut OK, Mancl L, Roberts MC, Briand K, Gancio MJ, Xylitol pediatric topical oral syrup to prevent dental caries: a double-blind randomized clinical trial of efficacy., Arch Pediatr Adolesc Med, 2009, 163, 7, 601-607, doi: 10.1001/archpediatrics.2009.77.

Additional files

Editorial Notes