Condition category
Oral Health
Date applied
07/02/2008
Date assigned
26/02/2008
Last edited
30/07/2008
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
Room B-509
Box 357475
Seattle
98195
United States of America
+1 206 543 4043
dfrc@u.washington.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

U54 DE14254

Study information

Scientific title

School-based xylitol gummy bears snacks: a randomized controlled trial

Acronym

Study hypothesis

Consumption of xylitol gummy snacks reduces S. mutans and Lactobacillus spp. levels

Ethics approval

University of Washington Internal Review Board. Date of approval: 27 March 2007 (ref: HS # 07-4857-B 01)

Study design

Randmised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

xylitol

Primary outcome measures

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 trial start date

01/04/2007

Overall trial end date

01/06/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Children attending First through Fifth grade at two elementary schools in rural Washington State, USA

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

153

Participant exclusion criteria

Children with gastrointestinal problems

Recruitment start date

01/04/2007

Recruitment end date

01/06/2007

Locations

Countries of recruitment

United States of America

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
Assistant to the Vice Provost for Research
Office of Sponsored Programs
1100 45th Street
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

Funders

Funder type

Research organisation

Funder name

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

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/18657266

Publication citations

  1. Results

    Ly KA, Riedy CA, Milgrom P, Rothen M, Roberts MC, Zhou L, Xylitol gummy bear snacks: a school-based randomized clinical trial., BMC Oral Health, 2008, 8, 20, doi: 10.1186/1472-6831-8-20.

Additional files

Editorial Notes